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VReeze: an open-source virtual reality for the examination of freezing of gait in Parkinsons disease - a study design of a crossover repeated measures study for validation

Por: Siragy · T. · Russo · Y. · Hirschbichler · S. · Nantel · J. · Wegscheider · P. · Schweiger · H. · Simonlehner · M. · Kisiel · M. · Horsak · B.
Introduction

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.

Methods

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.

Ethics and dissemination

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.

Advancing evidence‐based practice through the Knowledge Translation Challenge: Nurses’ important roles in research, implementation science and practice change

Abstract

Aim

To describe a knowledge translation capacity-building initiative and illustrate the roles of nurses in practice change using an exemplar case study.

Design

The report uses observational methods and reflection.

Methods

The Knowledge Translation Challenge program involves a multi-component intervention across several sites. The advisory committee invited eligible teams to attend capacity-building workshops. Implementation plans were developed, and successful teams receive funding for a 2 year period. Evaluation involved collecting data on program uptake and impact on practice change. Data has been collected from five cohorts. The exemplar case study employed an action-research framework.

Results

Four nurse-led teams have demonstrated successful implementation of their practice change. The case study on implementing a clinical toolkit for clozapine management further illustrates a thoughtful planning process, and implementation journey and learnings by a team of nurses.

Conclusion

The Knowledge Translation Challenge program empowers nurses to use implementation science practices to enhance the quality and effectiveness of healthcare services. Success of this initiative serves as a model for addressing the persistent gap between knowledge and practice in clinical settings and the value of activating nurses to help close this gap.

Implications

As the most trusted and numerous profession, it is vital that nurses contribute to efforts to translate research evidence into clinical practice. The Knowledge Translation Challenge program supports nurses to lead practice change.

Impact

The Knowledge Translation Challenge program successfully equips nurses and other health care providers with the knowledge, skills and resources to implement practice improvements which enhance the quality and effectiveness of healthcare services and nursing practice.

Patient or Public Contribution

The Knowledge Translation Challenge advisory committee has three patient-public partners that support teams to develop a patient-oriented approach for their projects by providing feedback on the implementation plans. Each team was also supported to include patient-public partners on their project.

Human Placenta‐Derived Cells (PDA‐002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi‐Center, Randomised, Double‐Blind, Placebo‐Controlled Trial

ABSTRACT

The management of diabetic foot ulcers in patients with peripheral artery disease remains challenging. Human placenta-derived cells (PDA-002), a mesenchymal stromal cell-like population obtained from full-term placental tissue, possess angiogenic and tissue regenerative properties. Participants were stratified based on peripheral artery disease status. A total of 159 individuals were randomly assigned to receive intramuscular PDA-002 at one of three doses (3 × 106, 10 × 106 and 30 × 106 cells) or a placebo. This Phase 2 multi-center, randomised, double-blind, placebo-controlled trial evaluated adults with chronic diabetic foot ulcers with and without peripheral artery disease. The primary efficacy endpoint was the proportion of participants achieving complete wound closure of the index ulcer within 3 months, with sustained closure maintained for an additional 4 weeks. PDA-002 was well-tolerated, with no treatment-related serious adverse events. Intramuscular PDA-002 treatment achieved the highest efficacy at the 3 × 106 cell dose within the peripheral artery disease subgroup (38.5% vs. 22.6% for placebo), meeting a stringent 4-week durability endpoint that surpassed the U.S. Food and Drug Administration's recommended 2-week sustainability criterion. PDA-002 shows promise as a breakthrough treatment for diabetic foot ulcers and peripheral artery disease, demonstrating efficacy with two intramuscular doses and no re-treatment.

Trial Registration: ClinicalTrials.gov identifier: NCT # 02264288

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