Cognitive impairment and upper limb impairment are common complications following stroke, but rehabilitation interventions targeting post-stroke cognitive and upper limb motor deficits remain understudied. Transcutaneous electrical nerve stimulation, including transcutaneous vagus nerve stimulation (tVNS) and transcutaneous spinal cord stimulation (tSCS), can potentially alleviate cognitive impairment and promote motor recovery. Although tVNS and tSCS may facilitate neuroplasticity following stroke, their effects on cognitive and upper limb motor outcomes have not been sufficiently studied. Therefore, the proposed clinical trial will investigate the effects of tVNS and tSCS on cognitive function and upper limb motor function in people with chronic stroke.

A three-arm sham-controlled single-blind parallel-group randomised controlled trial will be performed with people with chronic stroke. All participants (n=90) will be randomly allocated to receive 18 sessions of intervention with different stimulation protocols (tVNS, tSCS and sham stimulation) at a 1:1:1 ratio. All participants will receive upper limb exercises concurrent with the corresponding stimulation protocols for 45 min in each session, three sessions per week, for 6 weeks. The primary outcomes will be the Montreal Cognitive Assessment and Fugl-Meyer Assessment for Upper Extremity. The secondary outcomes will be the Rivermead Behavioural Memory Test, Digit Span Test, Trail Making Test, Wolf Motor Function Test, maximum isometric voluntary contraction of the elbow, muscle stiffness of the elbow extensor and flexor, Arm Activity Measure, Oxford Participation and Activity Questionnaire and 12-item Short-Form Survey. All outcomes will be assessed at baseline, after 9 and 18 sessions of the intervention, and 1 month after the cessation of the intervention.

Ethical approval has been obtained from the Human Subjects Ethics Committee of The Hong Kong Polytechnic University (HSEARS20221011002). The results yielded from this study will be submitted for publication in peer-reviewed journals and at international conferences.

NCT05615610.

Patients undergoing anterior cruciate ligament reconstruction (ACLR) and patellar fracture frequently present with substantial pain, swelling and inflammation. These pathophysiological changes not only intensify postoperative pain but also compromise the intra-articular environment via mechanical compression and localised microcirculatory deficits, thereby impeding recovery. Conventional interventions for postoperative swelling, such as cryotherapy and physical agent modalities, are commonly applied yet exhibit limited efficacy. Multilayer low-stretch bandage (MLB), with its gradient compression properties, has recently demonstrated superior swelling control and functional restoration; however, existing research primarily assesses short-term outcomes and lacks a systematic analysis across the postoperative continuum—acute, subacute and chronic phases—as well as long-term follow-up. This study therefore employs a multi-temporal intervention design and extended follow-up to evaluate the effectiveness of MLB in managing swelling, modulating pain and enhancing long-term knee function and activities of daily living across different recovery stages. The findings aim to furnish high-level evidence for knee rehabilitation protocols, refine clinical practice and ultimately improve patient quality of life.

This prospective, single-blind, randomised controlled trial will enrol 36 patients following ACLR and patellar fracture. Participants will be allocated at a 1:1 ratio through computerised randomisation to either an experimental group receiving MLB plus conventional rehabilitation, or a control group receiving conventional rehabilitation alone. The study spans 12 weeks, with follow-up assessments scheduled at baseline (T0), 4 weeks (T1), 8 weeks (T2) and 12 weeks (T3). Outcome measures comprise the Hospital for Special Surgery (HSS) Knee Rating Score, affected limb oedema regression rate, Visual Analogue Scale (VAS) pain score, knee range of motion, quadriceps and hamstring muscle strength, centre of pressure (COP) displacement parameters, proprioceptive testing, the 36-Item Short Form Health Survey (SF-36) and the Holden Walking Function Classification. A subsequent 1-year follow-up will assess long-term efficacy and patient satisfaction, while adverse events are strictly monitored throughout the entire study period. Adherence to Consolidated Standards of Reporting Trials guidelines is maintained, and a single-blind design ensures that both participants and assessors remain unaware of group assignments. This trial aims to establish an evidence-based foundation for optimising postoperative rehabilitation in this patient population.

Ethical approval for the study was obtained from the Medical Ethics Committee of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School (2025-0141-01). The results of the study will be published in a peer-reviewed medical journal.

ClinicalTrials.gov chiCTR2500100566. Registration date is 10 April 2025.

Cognitive impairment is a common consequence after stroke. Intermittent theta burst stimulation (iTBS) has emerged as a promising cognitive therapy. However, traditional iTBS typically employs lower doses and one-size-fits-all stimulation targets, which may not fully capitalise on the potential of this therapy and warrants further evaluation for both efficacy and safety. This study aims to evaluate the efficacy and safety of high-dose iTBS targeting the individualised frontoparietal cognitive network (FCN) identified by precision functional neuroimaging for post-stroke cognitive impairment (PSCI).

This is a prospective, double-blind, sham-controlled, parallel-group randomised controlled trial. 60 eligible participants with PSCI will be randomly assigned (1:1) to an active iTBS or a sham-controlled group. The active group will receive high-dose iTBS (3600 pulses/day) at 80% resting motor threshold targeting the left individualised FCN, guided by a real-time neuronavigation system. The sham group will follow identical procedures using a sham coil. Both groups will also undergo conventional computerised cognitive training. The intervention will be administered on workdays over a period of 3 weeks, totalling 15 workdays. The primary outcome is the change in Montreal Cognitive Assessment scores from baseline to immediately post-treatment. Secondary outcomes include long-term change in global cognition, activities of daily living and specific cognitive domains (assessed by a comprehensive neuropsychological battery covering memory, attention, executive function and language), as well as mood. Assessments occur at baseline, post-treatment and 3-month follow-up. Safety outcomes, specifically the number of adverse events related to iTBS, will be monitored and recorded throughout the trial.

This study has been approved by the Medical Ethics Committee of the China Rehabilitation Research Center. The results of this study will be published in peer-reviewed scientific journals and disseminated at academic conferences.

NCT05953415.

This systematic review and meta-analysis aims to provide an overview of the effectiveness of digital physiotherapy interventions on pain, physical functions and quality of life for patients with knee osteoarthritis.

Systematic review and meta-analysis using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) approach.

A systematic search of electronic databases, including MEDLINE, EMBASE, Web of Science, PsycInfo, CINAHL, Scopus and Cochrane Library, was conducted on 19 February 2025.

We included randomised controlled trials which compared digital physiotherapy interventions to standard physiotherapy care for patients with knee osteoarthritis. Main outcomes included pain, physical functions and quality of life.

25 studies met the inclusion criteria, and 18 studies were eligible for meta-analysis. The primary author conducted the initial search, selected articles and extracted data from eligible studies, which were independently checked by a second reviewer. Risk of bias (ROB) was assessed by Cochrane ROB-2 tool. Quality of evidence was evaluated by the GRADE approach.

Overall, digital physiotherapy was associated with a small but statistically significant improvement in physical function (SMD=0.24, 95% CI 0.13 to 0.35); an overall meta-analysis was not performed for pain and quality of life due to considerable heterogeneity. Subgroup analyses revealed both video-conferencing and app- or web-based physiotherapy significantly reduced pain (SMD=–0.53, 95% CI –1.06 to –0.01 and SMD=–0.47, 95% CI –0.70 to –0.25, respectively) and physical function (SMD=0.32, 95% CI 0.10 to 0.54 and SMD=0.30, 95% CI 0.09 to 0.50 respectively). Digital physiotherapy interventions with individualised exercise components also reduced pain (SMD=–0.43, 95% CI –0.66 to –0.21) and improved physical function (SMD=0.30, 95% CI 0.17 to 0.43), when compared with non-exercise interventions.

There was moderate-quality evidence to support the use of digital physiotherapy interventions in improving pain and function in patients with knee osteoarthritis. Subgroup analyses revealed low-to-moderate quality evidence in using video-conferencing and app-/web-based physiotherapy and interventions with exercise components to treat patients with knee osteoarthritis. Overall, there were limited high-quality trials in drawing a robust conclusion. High ROB and huge heterogeneity were observed across studies. Further research should minimise the ROB and investigate the effect of different digital modalities, intervention components and length of follow-up.

This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.

A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.

The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.

Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.

Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.

The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.

ISRCTN74668529.

Chronic low back pain (CLBP) is a leading cause of disability worldwide, significantly affecting patients’ quality of life. Functional restoration programmes (FRPs) are recommended to improve functional abilities and alleviate kinesiophobia, but the integration of emerging technologies like immersive virtual reality (VR) remains underexplored. VR has shown potential in reducing pain and enhancing motor imagery (MI), but its application in group-based rehabilitation for CLBP is novel. This study protocol aims to assess the feasibility and acceptability of adding immersive VR to multicentre FRPs for CLBP.

This multicentric, prospective, single-arm exploratory pilot study assesses the acceptance of incorporating an immersive VR headset into FRP for patients with CLBP. Participants will include healthcare providers and patients from centres in the Lombaction network. Patients will engage in standard FRP alongside three weekly VR sessions targeting trunk mobility and pain reduction. The primary objective is to evaluate the acceptance of the VR device among healthcare providers and patients (Unified Theory of Acceptance and Use of Technology 2-based questionnaire). Secondary outcomes include acceptability, usability (System Usability Scale), adherence, safety and effects on kinesiophobia, MI, pain levels and functional capacities. Data collection includes baseline and post-intervention questionnaires, adherence monitoring and standardised scales (eg, Tampa Scale for Kinesiophobia, Dallas Pain Questionnaire).

Ethical approval was granted by Comité de Protection des Personnes Sud-Est VI on 10 January 2025; all participants will provide written informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summaries to participating centres.

NCT06724679.

Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.

Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.

The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.

CTRI/2024/06/068838.

The main clinical symptoms of patients with chronic rotator cuff injuries (CRCI) include pain and/or limitation of movement, which severely reduce the function of the shoulder joint. Local injection of corticosteroid with local anaesthetics can control the inflammatory response and effectively relieve patients’ pain in the short term. In addition, rehabilitation exercises are considered an important tool for improving shoulder function. However, due to the presence of pain or substandard execution of movements, it is often difficult for patients to achieve the desired therapeutic effect. Although there are many options for digital rehabilitation, relatively few purely conservative treatments have been used for patients with CRCI. And even fewer studies have addressed how to improve exercise accuracy in such patients.

This protocol comprises three phases. First, shoulder active motion data will be collected from patients with CRCI and analysed using K-means clustering to define distinct clinical rehabilitation stages based on movement patterns and biomechanical principles. The clinical stages will be validated using one-way analysis of variance (ANOVA) and cross-tabulation to evaluate interstage functional differences and clinical consistency. Second, a shoulder rehabilitation system with real-time feedback will be developed, and its usability evaluated through a pilot study incorporating the System Usability Scale, Simulator Sickness Questionnaire and semistructured interviews. Finally, a randomised controlled trial will be conducted. 60 participants will be randomly allocated to either G1 (corticosteroid injection+digital rehabilitation) or G2 (corticosteroid injection+traditional home rehabilitation). The primary outcome is the Constant-Murley Score. Secondary outcomes include range of motion, Numerical Rating Scales, University of California at Los Angeles Shoulder Score, movement accuracy and exercise attitude questionnaire. Between-group comparisons will use independent t-tests or Mann-Whitney U tests, and within-group changes will be analysed with repeated measures ANOVA or Friedman test, with post hoc Bonferroni-adjusted comparisons.

The protocol was approved by the Medical Ethics Committee of Gongli Hospital, Pudong New Area, Shanghai (number: GLYY1s2024-031). All participants will provide informed consent prior to enrolment. The study findings will be disseminated through publication in a peer-reviewed journal or presentations at relevant national and international academic conferences.

ChiCTR2500097903.

Postoperative rehabilitation after anterior cruciate ligament reconstruction (ACLR) is crucial for functional recovery. Prehabilitation, performed before surgery, is considered to optimise the patient’s condition and improve postoperative outcomes. However, the evidence supporting the effectiveness of standardised prehabilitation protocols remains insufficient, particularly in comparison to conventional home rehabilitation programmes. This study aims to evaluate the impact of a 2-week standardised preoperative prehabilitation programme versus home rehabilitation training on perioperative functional outcomes and medium-term to long-term recovery in ACLR patients through a randomised controlled trial, providing evidence-based guidance for optimising rehabilitation pathways.

This study is a single-centre, prospective, assessor-blinded, randomised controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to the experimental group (receiving 2 weeks of standardised preoperative rehabilitation) or the control group (receiving 2 weeks of home-based rehabilitation training). Both groups will undergo 12 weeks of standardised rehabilitation postoperatively. The outcome measures include International Knee Documentation Committee Score (IKDC), Knee Injury and Osteoarthritis Outcome Score, Visual Analogue Scale, muscle strength, joint range of motion, anterior cruciate ligament-Return to Sport after Injury Index and Tegner score. The assessment time points are as follows: baseline (T0), 1–3 days preoperatively (T1), postoperative day 1 (T2), 30 days (T3), 90 days (T4), 180 days (T5) and 360 days (T6). All assessments will be performed at fixed time intervals within the same department of rehabilitation medicine, with the testing order randomised. The primary outcome (IKDC) will be analysed using a linear mixed model (LMM), including time, group and their interaction as fixed effects, with individuals as random effects. Secondary outcomes will be analysed using LMM, repeated measures analysis of variance or ² tests. Missing data will be handled using the multiple imputation method, under the assumption that data are missing completely at random and effect sizes will be evaluated using Cohen’s d (α=0.05).

This study has received approval from the Ethics Committee of the Second Affiliated Hospital of Xi’an Jiaotong University (Number: 2025012). All participants will provide written informed consent after reviewing documentation containing comprehensive details regarding the study procedures, risks and benefits, enabling informed decision-making about participation. The findings generated from this research will be disseminated via publication in an open-access, peer-reviewed journal and presented at relevant scientific conferences.

ChiCTR2500097293.

Adolescent idiopathic scoliosis (AIS) involves three-dimensional structural spinal changes, frequently accompanied by scapular dyskinesis (SD) and proprioceptive dysfunction. Although physiotherapeutic scoliosis-specific exercises effectively correct spinal alignment, their efficacy in addressing SD and associated sensorimotor deficits remains underexplored. This randomised controlled trial (RCT) will evaluate whether integrating upper limb proprioceptive neuromuscular facilitation (PNF) with conventional physical therapy yields synergistic improvements in scapular kinematics and proprioceptive function in AIS.

This single-centre RCT will be conducted at the Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 48 adolescents with AIS will be randomly assigned to either a control group (n=24) receiving conventional physical therapy or an experimental group (n=24) receiving combined conventional therapy and upper limb PNF interventions. Both groups will follow a structured 60 min rehabilitation programme, administered five sessions per week for 8 weeks (including two outpatient sessions and three home training sessions per week). Follow-up assessments will be conducted at 12 weeks postintervention to evaluate the maintenance of therapeutic effects. Primary outcomes will include the scapular balance angle and the active relocation test for shoulder proprioception. Secondary outcomes will comprise the scapular index, the lateral scapular slide test, normalised surface electromyography (root mean square, %muscle activation degree) of the upper trapezius, lower trapezius, serratus anterior, posterior deltoid and infraspinatus during standardised tasks, posture analysis, Cobb angle, angle of trunk rotation and the Simplified Chinese version of the Scoliosis Research Society-22 questionnaire for health-related quality of life. Data will be analysed using Analysis of Covariance and linear mixed-effects models, adjusted for baseline values, following the intention-to-treat principle.

The study protocol has been approved by the Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (Approval No. TJ-IEB2025-018) and has been registered on ClinicalTrials.gov. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.

ChiCTR2500099252.

Upper limb task-oriented training (UL-TOT) is a complex intervention in which practice conditions related to motor learning principles are applied to enhance upper limb motor recovery after stroke. The Template for Intervention Description and Replication guidelines suggest that detailed reporting of a complex intervention is essential in published studies. Therefore, this review aimed to determine the extent to which practice conditions related to motor learning principles were reported in UL-TOT stroke clinical trials.

A comprehensive search was done using appropriate keywords in PubMed, CINAHL, Web of Science, Scopus and Cochrane databases from 2000 to 2024. Two reviewers independently conducted title screening, abstract screening and full-text evaluation based on the inclusion and exclusion criteria. A third reviewer resolved the conflicts between the two reviewers during the screening process. Finally, the articles that fulfilled the criteria were included for data extraction.

23 802 studies were retrieved, and 166 studies were retained. Practice conditions such as practice variability (98%), dosage (97%) and movement complexity (96%) were reported more frequently, task selection for practice (75%), challenging and progressive task practice (76%) were reported frequently, practice order (57%), practice distribution (51%), feedback type (44%) and timing (44%) were reported occasionally. Feedback frequency (37%) was reported rarely.

Practice conditions such as practice variability, dosage, movement complexity, task selection, challenging and progressive task practice were reported consistently, while practice distribution, order and feedback were reported inconsistently. Developing a standard checklist for practice conditions related to motor learning principles can improve detailed reporting of practice conditions in future UL-TOT stroke clinical trials. This can help researchers replicate and reliably implement the intervention in specific populations and build on and create more effective interventions.

To understand healthcare professionals’ views on current physiotherapy service provision in children with congenital heart disease (CHD), how physiotherapy could be better used post-cardiac surgery and perceived barriers to service expansion.

Cross-sectional survey using a one-off self-completed online questionnaire, with open and closed questions, in June–August 2024.

Each of the 12 level 1 paediatric cardiac surgical centres in the UK National Health Service and Children’s Health Ireland.

Healthcare professionals providing clinical care to children undergoing cardiac surgery.

80 responses were obtained, with at least one response from each centre. Healthcare professionals conduct motor, developmental and functional evaluations across all age groups, with referrals to physiotherapy primarily based on physical examination (39, 87%). They expressed dissatisfaction with community physiotherapy services (64, 81%) compared with inpatient services (29, 36%), although they indicated that expanding services would positively impact patients and families. There is a lack of consensus regarding intervention frequency, duration and which patient groups should be prioritised. Respondents identified a lack of funding as the primary barrier to service expansion (76, 95%). Reported barriers for families included volume of medical appointments (69, 86%), transportation (66, 83%) and finances (62, 78%).

Healthcare professionals appreciate the positive impact physiotherapy can have on post-surgical management of children with CHD. The importance of expanding services was emphasised. However, to effectively support clinical practice, it is crucial to understand which patient groups should be prioritised and at what stage, as well as determining the optimal amount of physiotherapy that positively impacts patient outcomes.

Many amputees experience phantom limb pain (PLP). Pharmacological management is the mainstay of treatment, but effectiveness is limited, and it is associated with significant side effects. Sensory discrimination training (SDT) is a non-pharmacological treatment for PLP. Previously, SDT required a clinician, or carer, to administer it, creating a barrier to real world use. In this trial, an automated SDT device (SP1X, 2pd Ltd, Middlesbrough, United Kingdom) for the self-management of PLP will be investigated for efficacy.

The Phantom Relief is a decentralised, randomised, placebo-controlled, mixed-methods, superiority trial. Participants will take part from their own homes, using an electronic data capture tool to complete all trial documentation. Eligible, consenting individuals with PLP (intensity rated as ≥4 on a 0–10 scale; n=100) will be randomised to receive the SP1X device (intervention group) or a placebo device SP1X7 (placebo group). The first and second treatment sessions will be observed via video call to provide set-up guidance and any additional advice needed. The primary outcome measure will be the McGill Pain Questionnaire revised (SF-MPQ-2). Outcome measures will be collected at baseline, 3 weeks (immediately post intervention) and 3 months follow-up. Statistical analysis will be carried out by a blinded statistician (analysis of covariance model conditioning on the baseline and stratification factors). Semi-structured interviews will be carried out with a sub-sample (n=10–15) of intervention group participants. Participants will be provided with their allocated device for home use. Online video calls will be used to instruct participants on how to set up and use the device by the research assistant (RA). The RA will observe the first and second treatment sessions and provide any additional advice needed. Participants in both groups will be asked to use the device for 60 min/day for at least 15 days of the 21-day treatment period and to record device use in a study diary.

Approval has been obtained from Teesside University School of Health and Life Sciences Research and Ethics Committee, the North of Scotland Research Ethics Service, Health Research Authority, and a letter of no objection was obtained from the Medicines and Healthcare products Regulatory Authority. The results will be disseminated through peer-reviewed articles, conference presentations and a doctoral thesis.

NCT04103983.

Parkinson’s disease is the second most prevalent neurodegenerative disease worldwide, with up to 70% of patients exhibiting freezing of gait (FOG). FOG is defined as transient episodes when one is unable to effectively engage in the stepping process (despite the intention to walk), which decreases or completely ceases forward movement. Although several FOG triggers have been identified, eliciting FOG remains challenging in research, hindering progress in research and therapy. Virtual reality (VR) offers a promising approach to evoke FOG during overground walking by combining environmental and neuropsychological triggers. This project aims to validate an existing open-source VR-FOG toolbox that integrates multiple triggers.

A within-subject repeated measures crossover study design with a 1-hour washout period will be used for this project to validate the VR-FOG toolbox. This will consist of three blocks (baseline non-VR, VR non-FOG and VR-FOG). All participants will first complete a baseline walking trial without VR, then be randomised to either the VR non-FOG environment—a virtual replica of the laboratory—or the VR-FOG environment containing multiple virtual FOG triggers. After a 1-hour washout period, they will complete the remaining VR condition. A crossover design will minimise ordering effects of VR conditions on FOG frequency and duration. Twenty participants with Parkinson’s disease with FOG will be tested at St. Pölten University of Applied Sciences (Austria) and 20 at the University of Exeter (UK) and will be recruited from local communities. Multisite testing will verify that the VR-FOG environment triggers FOG regardless of testing location.

Ethical approval was obtained from the Lower Austrian Ethics Commission and the University of Exeter review boards. All data will be anonymised, used solely for this project and securely stored in General Data Protection Regulation-compliant repositories. Study results will be presented at scientific conferences and published in peer-reviewed journals.

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

NCT06156176

Multiple sclerosis (MS) competence is crucial for caregivers of people with MS (PwMS). Having validated MS-specific tools to measure caregivers’ Sense of Competence (SoC) is fundamental to understand if they are coping with their role and/or need support and training. The aim of the study was to develop and validate the Caregiver SoC questionnaire for caregivers of PwMS (CareSoC-MS), a self-report questionnaire, to assess SoC in MS caregivers.

Cross-sectional study.

Italy.

191 MS caregivers (sex: 48.7% females; age: 58.6±12.6 years; education: 62.8% high-school/university) self-administered the 27-item CareSoC-MS questionnaire. Psychometric evaluation consisted of analyses of structural validity and reliability, construct validity and discriminant validity. The final version of the CareSoC-MS includes 14 items covering 4 relevant SoC domains: L1-Psychological well-being, L2-Impact on personal social life, L3-Efficacy of the provided care and L4-Satisfaction with one’s own performance as a caregiver.

The 14-item CareSoC-MS is a psychometrically valid questionnaire with no ceiling or floor effects. Test–retest reliability analysis showed significant intraclass correlation coefficients for L1 (0.80), L2 (0.96), L3 (0.88) and L4 (0.61). L1 and L2 were correlated with self-reported measures of burden, anxiety and depression. Care recipient disability was correlated with L1 and L2, caregiver sex with L1, and caregiver age with L3.

The CareSoC-MS is a valid self-report questionnaire that can be used in clinical practice and research. CareSoC-MS could inform healthcare professionals about how informal caregivers feel capable to face the caregiving requests and, in turn, could help prevent or postpone caregiver burden.

Due to the documented benefits of peripheral resistance training (RT) and inspiratory resistance training, known as inspiratory muscle training (IMT), in patients with cardiovascular disease, both exercise forms are regularly used in cardiac rehabilitation. However, little is known about the haemodynamic responses to different intensities of dynamic RT, isometric RT, and IMT in patients with coronary artery disease (CAD). This study is designed to evaluate and compare the acute haemodynamic responses elicited by different RT and IMT modalities in patients with CAD.

This study design is a prospective, single-centre, randomised crossover trial. A total of 20 participants with CAD will be included. All participants will undergo four different exercise training interventions: IMT, isometric wall squat training (IWS), dynamic leg press training (DLP) and isometric handgrip training (IHG). For each intervention, participants will perform two intensity modalities in randomised order: IMT (low vs high), IWS (low vs moderate), DLP (low vs high) and IHG (low vs moderate). The primary outcomes are the acute exercise-induced haemodynamic responses (esp. systolic blood pressure, pulse rate, stroke volume, cardiac output) across the different exercise training interventions, as well as the changes in haemodynamic responses during the recovery phase for each intervention. Secondary outcomes include changes in tissue oxygen saturation, oxygen saturation, and perceived dyspnoea and exertion. The study period is planned for 2025.

The study has been approved by the Ethics Committee of the German Sport University Cologne (Ethical Approval Code: 209/24). The findings will be disseminated through international peer-reviewed publications. This study is supported by the Alexander von Humboldt Foundation via the partnership with the Coordenacão de Aperfeicoamento de Pessoal de Nível Superior (CAPES)(CAPES-Humboldt Research Fellowship for Experienced Researchers) and by research funding from Edwards Lifesciences LLC (Limited Liability Company).

German Clinical Trials Register DRKS00035668.

Approximately half of stroke survivors experience persistent upper limb dysfunction, which impairs self-care, reduces independence and lowers quality of life. Electroacupuncture is an established intervention with evidence supporting its role in improving upper limb motor function following ischaemic stroke. Motor imagery training (MIT), which activates the sensorimotor cortex through the mental rehearsal of movement, has shown promise as an adjunctive therapy in stroke rehabilitation. The concurrent application of electroacupuncture and MIT may enhance sensorimotor recovery by promoting the integration of central and peripheral neural pathways, potentially establishing a central–peripheral–central closed-loop circuit. However, empirical evidence supporting this integrative approach remains limited.

This study aims to investigate the effects of electroacupuncture synchronised with MIT on upper limb function in patients with ischaemic stroke. In addition, longitudinal analysis of multimodal neuroimaging data will be used to explore the associated neural mechanisms.

A total of 72 patients with ischaemic stroke will be enrolled and randomly assigned (1:1) to receive either electroacupuncture synchronised with MIT or electroacupuncture. Each group will undergo 20 treatment sessions over 4 weeks (5 times per week). All participants will also receive standardised conventional rehabilitation training.

The primary outcome is the Fugl-Meyer Assessment for the upper extremity. Secondary outcomes include the Modified Barthel Index for activities of daily living, the Modified Ashworth Scale (MAS) for spasticity, Brunnstrom stages, the 17-item Hamilton Depression Rating Scale, the Chinese version of the Massachusetts Acupuncture Sensation Scale and the Kinaesthetic and Visual Imagery Questionnaire. Assessments will be conducted at baseline, mid-treatment, post-treatment and at 8-week follow-up. In addition, functional connectivity of the cerebral cortex will be assessed using functional near-infrared spectroscopy and electroencephalography, which may serve as potential biomarkers of treatment response.

This study has been approved by the Ethics Committee of Shanghai Second Rehabilitation Hospital (approval number: 2025-18-01) and has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR; registration number: ITMCTR2025001311). The study will be conducted in accordance with the Declaration of Helsinki, relevant local regulations and applicable clinical guidelines. Informed consent will be obtained from all participants or their legal guardians, where applicable. The results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

ITMCTR2025001311.

Globally, millions of abdominal surgeries are performed annually, placing a substantial burden on public health systems worldwide. Postoperative pulmonary complications (PPCs) are common negative consequences after major abdominal surgery that can worsen recovery outcomes. Although the effect of prehabilitation has been frequently investigated in this population, the feasibility and efficacy of delivering a supervised, intensive exercise programme within a limited preoperative period remain underexplored.

This randomised controlled trial (RCT) aims to evaluate the effectiveness of the SUPERvised PREhabilitation with Personalised, Aerobic training, Respiratory muscle training and patient EDucation (SUPER-PREPARED) multi-model to reduce the incidence of PPCs among the population undergoing abdominal surgery.

The SUPER-PREPARED trial will be a single-centre, prospective, two-arm RCT. A total of 120 participants will be recruited and randomly allocated to either the SUPER-PREPARED group or the usual care group. The primary outcome is the incidence of PPCs, assessed at specific time points (1 day before discharge and 1 month, 6 months and 1 year after surgery). The secondary outcomes include patient-centred measures (functional capacity, quality of life), clinical measures (respiratory muscle function, pulmonary function) and postoperative recovery metrics (postoperative intestinal ventilation timing, length of intensive care unit (ICU) stay, length of postoperative hospital stay, postoperative hospitalisation expenses and readmission rate). The detailed criteria defining PPCs and the schedule of the study are displayed in tables. Data analysis will be independently conducted by two experienced clinicians via the per-protocol analysis.

This study will be conducted in strict accordance with the Declaration of Helsinki (2024). The protocol was approved by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (2024 nianshen No. 2049). The final results will be disseminated by peer-reviewed journals and presentations at academic conferences.

ChiCTR2500102615.

Ankle injuries are highly prevalent in athletes and often lead to chronic instability, impaired postural control and altered gait mechanics that compromise performance and delay return to sport. Although specialised footwear and insoles are widely used to enhance stability and normalise gait, their true efficacy in athletic populations remains uncertain, warranting a systematic synthesis of current evidence.

This protocol follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include randomised, quasiexperimental and observational studies published up to 30April2025 that involve athletes with acute or chronic ankle injuries and evaluate footwear or insole interventions on balance and/or gait parameters. Five electronic databases (PubMed, Cochrane Library, Web of Science, Scopus, CINAHL) will be searched with tailored Medical Subject Headings (MeSH) terms and keywords. Two reviewers will independently screen records, extract data and assess methodological quality using the Effective Public Health Practice Project tool, which evaluates six domains: selection bias, study design, confounders, blinding, data collection methods and withdrawals/drop-outs, providing a global rating of strong, moderate or weak. Certainty of the body of evidence will be graded using the Grading of Recommendations Assessment, Development and Evaluation framework. Results will be synthesised narratively, grouping findings by intervention type, outcome measure, sport and assessment method.

No ethical approval is required as the review uses previously published data. Findings will be shared via peer-reviewed publication and scientific conferences.

Prospectively registered in PROSPERO under CRD420251031083.