Conectar
Poststroke motor dysfunction places a heavy burden on individuals and society. Virtual reality (VR) offers enhanced motor skill transfer and active rehabilitation by overcoming the scenario-specific constraints of conventional therapies. Validating the efficacy of VR rehabilitation could lead to scalable and cost-effective solutions, potentially enabling home-based rehabilitation. However, the widespread clinical application remains constrained by the lack of rehabilitation-specific VR and multidimensional quantitative assessments. The aim of this study was to investigate the multidimensional effects and neural mechanisms of VR rehabilitation in poststroke motor recovery.
This study is a prospective, randomised, controlled clinical trial protocol designed to evaluate the effects of multisensory VR training on motor dysfunction in patients who had a stroke using multidimensional assessments. The trial consists of a baseline assessment, a 4-week intervention period and an endpoint assessment. A total of 40 patients who had a stroke will be randomly allocated in a 1:1 ratio to either a VR combined with treadmill group or a treadmill-only group. The primary outcome measure is the Fugl-Meyer Assessment of Lower Extremity score, while secondary outcomes include three-dimensional gait analysis, the Berg Balance Scale score, the activities of daily living score and functional near-infrared spectroscopy results. Safety will be evaluated by monitoring the incidence of adverse events. This study aims to determine whether VR rehabilitation offers superior efficacy in improving motor function in patients who had a stroke by using a multidimensional assessment approach, including neural coupling function, muscle movement mechanics and clinical performance. The findings will provide robust, high-quality evidence to support the broader application of VR in clinical practice.
The trial was approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (2022–155). This study protocol was registered with the clinicaltrials.gov (NCT06275516). The results will be published in a peer-reviewed journal or presented at a conference.
Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.
A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.
This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.
Neck pain is a common issue among the working-age population, with a high recurrence rate and one of the highest healthcare costs globally. Exercise is proposed as one of the key components in managing this condition, and electrotherapy is established as a safe and proven analgesic measure. Telemedicine improves access to healthcare by removing geographical barriers and reducing costs, allowing consultations from any location and supporting the work-life balance of the patient.
The aim of this study is to compare the efficacy of e-Health versus a face-to-face programme in the therapeutic management of non-specific neck pain through exercise and analgesic electrotherapy.
A randomised clinical trial with 100 participants suffering from non-specific neck pain will be conducted. Participants will be evenly divided into two groups to receive analgesic electrotherapy combined with a cervical exercise programme delivered either via an e-Health programme or face-to-face programme. A total of 24 sessions will be administered over 8 weeks. Data collected will include demographic and clinical information, disability, pain intensity, fear of movement, sleep quality, catastrophising, quality of life and range of motion. Assessments will be conducted at the start of the study (baseline), at 8 weeks (post-treatment), and 2 months after completing the intervention (follow-up).
This protocol has been approved by the Andalusian Biomedical Research Ethics Coordinating Committee (SICEIA) with number register (SICEIA-2024-000820) on 25 September 2024. Findings will be disseminated through publications in peer-reviewed journals and presentations at international and national conferences.
ClinicalTrials.gov (NCT06842381).
Single-modality motor rehabilitation is often insufficient to address the complex functional restoration needs of patients with chronic ankle injuries following surgery. Research indicates that non-invasive neuromodulation techniques, such as intermittent theta-burst stimulation (iTBS), may enhance motor recovery by increasing cortical excitability and facilitating neural network reorganisation. Compared with exercise therapy alone, this study aims to explore the rehabilitation efficacy of combining iTBS with exercise therapy in patients with chronic ankle injuries following surgery. It also investigates the associated cortical network modulation, providing scientific evidence to optimise rehabilitation strategies for these patients.
This study is a prospective, multicentre, randomised controlled trial with single-blind assessment. A total of 28 patients with chronic ankle injuries following surgery were enrolled and randomly assigned to either the experimental group or the control group according to centre-stratified randomisation. The experimental group will receive iTBS combined with exercise therapy, while the control group will receive sham iTBS combined with exercise therapy. Both groups will undergo one session per day, 5 days per week, for a total of 3 weeks. The primary outcome measure will be the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score (AOFAS). Secondary outcome measures will include isokinetic muscle strength assessment of the ankle dorsiflexor and plantarflexor muscles, Visual Analogue Scale (VAS) scores, ankle joint range of motion (ROM) and the 10-Metre Walk Test. Functional near-infrared spectroscopy (fNIRS) and transcranial magnetic stimulation (TMS) will also be used to assess cortical functional activity and neurophysiological changes. All outcome measures will be collected at baseline prior to enrolment, post-intervention at week 3, and at follow-up at week 6. Primary outcomes analyses will use group-by-time comparisons to examine between-group differences in functional and neurophysiological measures.
The study has received approval from the Medical Ethics Committee of Jiangsu Province (Suqian) Hospital (Application No. 2025-SR-0333). All participants will provide written informed consent before enrolment. Results will be disseminated through peer-reviewed journals and scientific conferences.
ChiCTR2500110905.
V1.0.
Chronic low back pain (CLBP) remains a leading cause of disability worldwide and imposes a substantial personal and socioeconomic burden. Despite exercise being the first-line recommended intervention in clinical guidelines, its efficacy on pain relief remains modest and the hypoalgesia induced by exercise seems to be limited in individuals with musculoskeletal pain. Previous transcranial direct current stimulation (tDCS) studies have mainly targeted the motor cortex, yielding heterogeneous results, underscoring the need to evaluate alternative brain areas. Recently, tDCS studies targeting the dorsolateral prefrontal cortex (DLPFC) may enhance endogenous pain modulation and thereby potentiate the response to exercise. This study aims to compare the effects of adjunctive anodal DLPFC tDCS combined with a standardised exercise programme versus sham tDCS combined with the same exercise programme on pain and function in adults with CLBP.
This is a single-centre, triple-blinded, parallel-group randomised controlled trial. 48 participants with CLBP will be randomly assigned to receive either anodal tDCS over the left PFC combined with exercises, or sham tDCS combined with the same exercise programme, over nine sessions during a 3-week period. The primary outcome is the change in the multidimensional impact of CLBP, assessed using the Core Outcome Measures Index, from baseline to postintervention (week 4). Secondary outcomes include pain intensity, disability, psychological factors (fear-avoidance beliefs, catastrophising, anxiety, depression), measured at baseline, postintervention and at 12- and 24-week follow-up. Functional brain connectivity via electroencephalography and neuromuscular function of the erector spinae (flexion–relaxation phenomenon) will be measured at baseline and postintervention.
This study was approved by the Commission Cantonale d’Ethique de la Recherche sur l’être humain (CCER) in December 2022 (reference number: 2022-D0077). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed publications and presentations at national and international conferences.
This multi-centre, randomised controlled trial (RCT) investigates the effects of intensive upper limb (UL) motor training on neurophysiological and functional recovery in individuals with cervical spinal cord injury (c-SCI) during the sub-acute phase. The study aims first to assess neurophysiological adaptations in the central and peripheral nervous systems and functional changes to evaluate the impact of intensive UL motor training on recovery. Second, it determines dose dimensions and their correlation with neural and functional improvements.
A total of 44 individuals with c-SCI within 13 weeks post-injury will be recruited from five rehabilitation centres in Belgium and the Netherlands. They will be randomised into an intervention group, receiving six additional hours of goal-directed UL training per week for 8 weeks, or a control group receiving standard care. Primary outcomes are changes in resting motor threshold, a proxy for corticospinal tract integrity; compound muscle action potential amplitude, indicating peripheral nerve excitability and functionality; and assessments of strength, sensory function and prehension, with the primary comparison between groups at baseline and after the intervention period. Secondary outcomes cover additional neurophysiological assessments and motor function. Dose dimensions will be quantified and related to primary and secondary outcomes.
The central medical ethics committees, METC Máxima MC (NL84212.015.23) and MEC Gent (B6702023000227), as well as local ethics committees, reviewed and approved this trial. The protocol is registered (ClinicalTrials.gov; NCT06065384). The findings of this RCT will be disseminated through articles in peer-reviewed journals and at neurological rehabilitation conferences.
Non-specific low back pain (NSLBP) is one of the leading causes of disability worldwide. Emerging evidence suggests that altered diaphragmatic function may be associated with lumbar pain, impaired trunk stabilisation and functional disability. Manual diaphragmatic techniques have been proposed as an intervention to modulate diaphragmatic tension, mobility and neuromyofascial relationships; however, their effectiveness has not yet been synthesised using rigorous systematic review methods.
This protocol follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidance and has been prospectively registered in PROSPERO. Randomised controlled trials evaluating manual techniques specifically applied to the diaphragm in adults with NSLBP will be eligible. The primary outcomes will include pain intensity and functional disability; secondary outcomes will include lumbar mobility, respiratory function, quality of life and adverse events. Searches will be performed in PubMed/MEDLINE, Cochrane CENTRAL, PEDro, CINAHL, Scopus, Embase and clinical trial registries without language or date restrictions. Two reviewers will independently perform study selection, data extraction and risk-of-bias (RoB) assessment using the Cochrane RoB 2 tool. Where appropriate, a random-effects meta-analysis will be conducted; the certainty of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Substantial clinical and methodological heterogeneity is anticipated across trials, which may limit the feasibility of quantitative data pooling.
As this study uses data from previously published trials, ethical approval is not required. Findings will be disseminated through peer-reviewed publication, conference presentations and a plain-language summary for clinical stakeholders.
CRD420251172616.
To explore how individuals with long covid experienced various aspects of a micro-choice-based rehabilitation programme and if these experiences could facilitate behaviour change.
A qualitative study with three focus groups was conducted, in mean 9.8 months after completing the rehabilitation programme. Data were analysed using systematic text condensation.
The study was conducted in a university setting.
19 participants (aged 23–55 years, 15 women) were included between Spring 2021 and Autumn 2022.
The participants in this study had participated in a 3-day concentrated micro-choice-based rehabilitation programme. One of the main features of this intervention was to support participants in shifting their focus from targeting symptoms to choosing alternative actions aimed at improving everyday functioning, referred to as micro-choices.
Five themes were identified: (1) reduction in uncertainty achieved through reassurance and motivation; (2) ‘in the same boat’: sharing experiences and supporting each other; (3) knowledge about the body’s stress responses and micro-choices; (4) shifting between individual practice and close collaboration with the therapists; and (5) sustaining behaviour change is challenging. These themes illustrated how participants’ experiences with different aspects of the rehabilitation programme facilitated both the initiation and maintenance of behaviour change. The participants highlighted the importance of acknowledging their challenges, reducing fear, sharing experiences with peers, feeling understood and supported, collaborating with a skilled team, receiving personalised guidance and gaining insights through the exploration and implementation of micro-choices. Participants also highlighted that behaviour change is an ongoing process requiring sustained effort.
The findings showed how participants experienced various aspects of a concentrated micro-choice-based rehabilitation programme as supportive of behaviour change. The findings indicate that a concentrated rehabilitation programme may facilitate self-management and improve everyday function in individuals with long covid.
Pain, including phantom limb pain (PLP), residual limb pain (RLP) and low back pain (LBP), is highly prevalent after lower limb amputation (LLA) and compromises quality of life. Although both pain and function have been studied extensively, methods of assessment and reporting vary, limiting comparability. A clearer overview of how these domains are measured and interrelated is needed to guide research and practice.
To synthesise evidence on how postamputation pain and functional outcomes have been assessed and reported in adults with LLA, and to examine reported relationships between pain and mobility/function.
Scoping review guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
MEDLINE, Embase and PsycINFO (inception to 15 August 2025).
Quantitative studies that measured pain and functional outcome in adults with LLA.
Two reviewers independently extracted study characteristics, pain measures and functional outcomes in Covidence; findings were narratively synthesised.
Eighty-four studies were included. RLP (n=46), LBP (n=32) and PLP (n=28) were most frequently examined. Pain was mainly assessed by self-report scales; mobility was typically assessed by clinical tests and less often by biomechanical instrumentation. PLP was associated with altered gait and balance deficits; RLP with limited walking distance, asymmetric weight-bearing and reduced community participation; LBP with gait asymmetry, trunk–pelvis discoordination and increased energy cost of walking.
Postamputation pain is often linked to reduced mobility and functional limitations. However, heterogeneous definitions and inconsistent methodology hinder synthesis across studies. Future research should combine validated pain scales with objective analysis, wearable sensors and musculoskeletal modelling to clarify mechanisms and inform rehabilitation.
Adhesive capsulitis of the shoulder is a common shoulder disease. With the ageing population, the incidence of adhesive capsulitis has been rising year by year, posing a significant threat to the quality of life of middle-aged and elderly individuals. As one of the main means of treating adhesive capsulitis, manipulation under anaesthesia (MUA) can achieve good clinical results while maintaining high economic benefits. The purpose of this study is to investigate the prognostic factors and the longitudinal recovery trajectory of patients, so as to provide a basis for the precise treatment of MUA.
The study is a longitudinal prospective cohort study with a 12-month follow-up. A trajectory analysis model (latent growth curve modelling) will be used to observe the recovery changes of adhesive capsulitis patients. Linear mixed-effects models will be employed to analyse the prognostic factors of adhesive capsulitis.
Ethical approval was obtained from the Institutional Review Board of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (approval number: 2025-1707-047-02), following ethical guidelines and standard reporting practices. The research findings will be disseminated through presentations at both regional and global medical conferences.
ChiCTR2500100645.
Individuals with incomplete spinal cord injury (iSCI) often experience impaired balance control and turning-while-walking ability, which increase the risk of falls and limit their community mobility. While overground exoskeleton training has shown promise in improving gait and balance, evidence from randomised controlled trials (RCTs) on ambulation of individuals with iSCI remains limited. This protocol outlines a cluster RCT investigating the effectiveness of overground exoskeleton-assisted gait training compared with conventional training and usual care in improving turning-while-walking performence, balance control, and functional mobility in individuals with iSCI.
This multicentre, cluster RCT will compare 12-week interventions across three groups: (1) overground exoskeleton training group, (2) conventional training group and (3) usual care group. Participants with ambulatory iSCI will be recruited from three centres in Hong Kong SAR and mainland China. Primary outcomes include turning duration and number of steps during a 2-m turning-while-walking test. Secondary outcomes include static and dynamic balance, sensorimotor integration, gait performance, muscle strength, spasticity, quality of life, self-efficacy and fall incidence. Assessments will be conducted at baseline, mid-intervention, postintervention and at the 1-month follow-up.
This study has received approval from the Research Ethics Committees of Hong Kong Metropolitan University, the Affiliated BenQ Hospital of Nanjing Medical University, and Changzhou Sunshine Rehabilitation Hospital. Written informed consent will be obtained from all participants before enrolment. Study findings will be shared through peer-reviewed publications, conference presentations and summaries available to participants upon request.
Adults living with chronic conditions may need to access health programmes to mitigate health-related challenges that persist long after discharge from the hospital. Community physical activity programmes represent critical opportunities for health promotion and chronic disease self-management that can extend beyond hospital-based services. However, navigating the healthcare system and connecting to much-needed physical activity programmes can be challenging due to fragmentation of the health and social care system, especially for those who are transitioning between different healthcare providers, settings, stages of recovery and funding sources (eg, public, private). Patient navigation services can assist with this fragmentation by providing tailored support to individuals with chronic conditions. However, our understanding of patient navigation services in Canada is limited. This rapid review seeks to explore the landscape of patient navigation services supporting Canadians with chronic conditions in connecting to physical activity programmes in the community.
The rapid review will follow the recommendations published by Garritty et al in 2024. Integrated Knowledge Translation will be employed to facilitate meaningful engagement of people with lived experience of chronic conditions throughout the entire research process. Studies published in English that examine patient navigation services in physical activity for community-dwelling Canadians with chronic conditions will be included. Ovid MEDLINE, Embase, Emcare, CINAHL and Google Canada will be searched for articles published from 1990 to May 2025 to identify the characteristics, strengths and limitations, and prioritised features of patient navigation services for community physical activity programmes. The Mixed Methods Appraisal Tool will be used to assess the quality of included studies.
This protocol is a rapid review of published literature and does not require ethical approval. Review findings will be disseminated to various key interest groups through publications, presentations, infographics, social media posts and/or videos.
This study aims to evaluate relationships between self-reported fine motor ability and quality of life (assessed by life satisfaction and life problems) from people with spinal cord injury (SCI) at T1 and above.
Observational cohort study (current analysis from a cross section)
279 individuals with SCI at T1 or above
Community members sampled from records from two Midwestern hospitals and a speciality hospital in the Southeast United States
Fine motor ability was assessed via the Spinal Cord Injury Functional Index-Short Form 9A, while two facets of quality of life, life satisfaction and life problems, were assessed by the Life Situation Questionnaire-Revised version (LSQ-R). Pearson correlations and multivariate analysis were utilised to identify cross-sectional relationships between fine motor ability, life satisfaction and life problems.
Fine motor ability was positively correlated with total life satisfaction score (r=0.16; p=0.02) and was negatively correlated with the total life problems score (r=–0.18; p=0.01), health problems factor (r=–0.24; pβ=0.25; p=0.02), fewer life problems (β=–0.40; pβ=–0.11; pβ=–0.10; p
The results identified significant, modest associations between self-reported outcomes, as better fine motor ability was related to less social isolation, fewer health problems and higher life satisfaction. Further investigation into the relationship between fine motor ability, life satisfaction and life problems is warranted.
Soft robotic gloves (SRGs) integrated with brain-computer interfaces (BCIs) have demonstrated potential in facilitating motor recovery after stroke by enabling active, intention-driven rehabilitation. Emerging evidence suggests that incorporating vibrotactile stimulation (VTS) into SRG-BCI systems may further enhance sensorimotor feedback. The objective of this study is to evaluate the therapeutic efficacy and underlying neural mechanisms of BCI-driven, intention-based glove activation compared with automated glove-assisted training, with VTS applied identically in both groups.
This multicentre, single-blind, randomised controlled trial will involve 48 post-stroke patients within 1 week to 3 months after stroke onset, with stratification by time since stroke during randomisation. Participants will be randomly assigned to either the BCI-SRG group (n=24) or SRG group (n=24). Both groups will receive identical VTS. Patients in the BCI-SRG group will actively initiate movements of the SRG through motor imagery, while those in the SRG group will receive automated glove-assisted training without BCI control. The intervention will be administered 5 days per week for 4 weeks. The primary outcome measure is the Fugl-Meyer Assessment of Upper Extremity. Secondary outcome measures include Wolf Motor Function Test, International Classification of Functioning, Disability and Health Generic Set, Barthel Index, Modified Ashworth Scale, Semmes-Weinstein Monofilament Test, as well as event-related spectral perturbation and event-related desynchronisation. All assessments will be conducted at both baseline and post-intervention.
Ethics approval of this study protocol has been obtained from the Ethics Committee of the First Affiliated Hospital with Nanjing Medical University (2025-SR-508). The findings will be disseminated through peer-reviewed journals, conference presentations and communication with scientific, professional and general public audiences.
ChiCTR2500106951.
To explore long-term physical activity (PA) among patients 2 years post-transcatheter aortic valve replacement (TAVR) and assess the impact of syncope history on post-TAVR activity.
This was a cross-sectional study conducted using an on-site questionnaire.
In this cross-sectional study, we used convenience sampling to recruit participants from the outpatient department at a tertiary hospital in Shanghai, China, between July 2023 and December 2023.
Patients who had undergone TAVR for 2 years or more were included in the study.
The self-reported PA levels were assessed using the validated Chinese version of the International Physical Activity Questionnaire-Short Form. Additionally, medical records of the patients were thoroughly reviewed to accurately document the history of syncope for everyone.
Via convenience sampling, we recruited 179 consecutive participants aged 60 years and older who underwent TAVR. Only 36.31% (65/179) of patients remained physically active ≥2 years post-TAVR, with 27.37% having a syncope history. After adjusting for potential confounders, a history of syncope was independently associated with significantly lower levels of long-term PA (adjusted OR 0.287, 95% CI 0.122 to 0.675). This negative association was particularly pronounced among men and individuals with a normal body mass index (BMI).
A history of syncope is a strong independent predictor of reduced PA in the long term after TAVR. These findings highlight that patients with a history of syncope, especially men and those with normal BMI, represent a high-risk subgroup warranting particular attention in post-TAVR care. Targeted assessment and rehabilitation strategies should be considered for this population, and further research is needed to elucidate the underlying mechanisms.
Children with bilateral cerebral palsy (BCP) frequently develop progressive gait impairments driven in part by muscle weakness. Although power training, which involves high-velocity loaded movements, can enhance functional capacity, its substantial physical demands often limit feasibility in this population. Blood flow restriction (BFR) training has emerged as a promising alternative, capable of eliciting comparable physiological benefits while using low-intensity exercise. This study evaluates the feasibility, safety and clinical effects of integrating BFR with treadmill training in children with BCP, an innovative approach that may deliver the advantages of intensive strengthening while reducing physical burden.
This single-centre pilot study uses a double-baseline design with 13 participants with BCP (Gross Motor Function Classification System II-III), aged 8–18. The protocol consists of a 10-week usual care period followed by a 10-week Blood Flow Restriction Treadmill Training (BFR-TT) intervention, with three sessions per week. Feasibility targets were defined as completion of at least 80% of at least 80% of sessions. Safety is monitored through pain scales and adverse events. Outcomes assess body function (strength, GAITRite), activity (walking speed, walking endurance and motor function) and participation (daily activities), comparing changes between the usual care and BFR-TT periods.
This study was approved by the French Protection of Persons Committee (2024-A00791-46). Results will be published in peer-reviewed journals and presented at international conferences.
Chronic non-specific low back pain (CNLBP) is a multifactorial disease involving physical dysfunction and psychological distress. Acupuncture and mindfulness-based stress reduction (MBSR) are two non-pharmacological therapies recommended by guidelines, which have been proven effective in improving the clinical symptoms of CNLBP. However, the efficacy of their combined use has yet to be explored. This study aims to explore whether the combination of acupuncture and MBSR would have different synergistic effects in patients with CNLBP compared with acupuncture or MBSR alone.
This protocol describes a randomised controlled trial with a 2x2 factorial design involving 120 CNLBP patients. Participants will be randomly allocated to four groups: (1) acupuncture, (2) MBSR, (3) acupuncture combined with MBSR, and (4) health education. The intervention period is 6 weeks. The outcome measurements will include the Visual Analogue Scale (VAS), Tactile Acuity Test, Short-form of McGill Pain Questionnairethe(SF-MPQ); Roland-Morris Functional Disability Questionnaire (RMDQ), Oswestry Disability Index(ODI), the Five Facet Mindfulness Questionnaire (FFMQ), the 21-item Depression Anxiety Stress Scales (DASS-21), the Regulatory Self-Efficacy Scale (RESE), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS);Pain Sensitivity Questionnaire(PSQ); Pittsburgh Sleep Quality Index(PSQI). All evaluations will be conducted at the baseline stage as well as 6 weeks and 4 months after the implementation of the intervention measures.
Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine (2024KY-041-04). The results of the study will be disseminated through peer-reviewed publications and at scientific conferences.
ITMCTR2025000764.
To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.
Pilot cluster randomised controlled trial (c-RCT).
Community-based healthcare services across six UK sites representing primary and secondary care settings.
31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.
The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.
Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.
Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.
The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.
ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).
To examine the emotional, cognitive and dispositional experience of children and adolescents undergoing Lokomat rehabilitation by integrating self-evaluation, therapist observations and physiological metrics across repeated sessions, with the aim of characterising how patient experience evolves throughout paediatric robot-assisted gait training.
Prospective observational study using a multidimensional assessment approach combining self-report, therapist ratings and physiological measures.
Inpatients undergoing robot-assisted gait training (RAGT) with the Lokomat at the Scientific Institute Eugenio Medea in Bosisio Parini (Italy).
42 children and adolescents (N=42; mean age 11.66±5.59 years) undergoing RAGT.
Robot-assisted gait therapy with the Lokomat. Participants underwent 30-minute therapy sessions as per routine rehabilitation protocols, with treatment durations ranging from 15 to 20 sessions, as prescribed by their referring clinician.
Participants completed ad-hoc questionnaires about emotional, cognitive and dispositional factors before and after therapy; therapists provided structured assessments of patient engagement and psychological states. Physiological data, such as heart rate variability (HRV) and electrodermal activity (EDA), were recorded using wearable sensors to capture physiological correlates of emotional and cognitive engagement.
The results showed that by the end of Lokomat therapy, patients displayed increased cognitive engagement and better emotional regulation, along with higher vagal activity (normalised high-frequency) and increased phasic EDA responses. According to the therapists, patients appeared more confident, calm and cooperative. Sympathetic activation observed during satisfaction ratings reflected the involvement of the autonomic nervous system in positive emotional experiences.
This study, therefore, emphasises a multidimensional approach to rehabilitation, which involves subjective patient self-assessments, therapist observations and physiological signals in an effort to capture a more comprehensive patient experience. The findings highlight the importance of personalised, patient-centred approaches and contribute new evidence on the psychological and physiological effects of RAGT in paediatric populations. Further research is warranted to confirm these results and explore their clinical implications.
To qualitatively explore the lived experiences and perceptions of patients with chronic obstructive pulmonary disease (COPD) using the harmonica as a therapeutic intervention.
A qualitative study.
The study was conducted at a tertiary hospital in Guangzhou, China.
Patients with COPD who had participated in supervised harmonica playing for at least 12 weeks. (clinical trial registration: NCT05995847).
The study focused on patients’ experiences, including perceived facilitators, barriers and needs regarding the intervention.
We interviewed 19 patients with COPD between September and December 2024, with interviews lasting an average of 54 min (range: 36–77 min). Five primary themes were identified. Participants reported better physical functioning, including better breathing control, enhanced functional capacity and improved sleep quality. Psychological well-being improved with increased relaxation, emotional improvement and mental engagement. Patients also experienced increased social engagement and role shift, such as expanded social connections, family support and restored family roles. Harmonica playing promoted enhanced self-reliance and personal development, with increased self-management confidence, mastery of the harmonica and encouragement for lifelong learning. Barriers and challenges included physical limitations, breathing difficulties, adherence issues and concerns about the sustainability of long-term benefits.
Our study indicates that harmonica playing could improve physical health, psychological well-being, social participation and self-reliance, although barriers persist. Tailored programmes could enhance benefits and adherence, and future research should evaluate durability within comprehensive COPD care.
FreshRSS 