Efficacy of NOn-immersive Virtual Reality Adapted Telerehabilitation Exercises for Upper Limb Function and Balance (NOVEL) Program in Stroke Patients: A Mixed Method Pilot Feasibility Study.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Strokes are estimated to be the third most common cause of death in the world and the second most common cause of disability. Recently, the incidence of stroke has increased due to population aging. It is common for stroke survivors to experience a functional decline in their capacity to carry out daily activities as a consequence of their increasing dependence, which ultimately affects motivation levels, self-efficacy, and quality of life. Following a stroke, people often experience problems with upper limb function. Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward. A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance, but such interventions are difficult to access. As a cutting-edge method of neurorehabilitation, extended reality technology like virtual reality provides a more intensive simulation of functional activities than traditional physical therapy methods (aerobic, resistance, flexibility exercises, balance and coordination training, and functional exercises. The non-immersive type of VR can provide the patient with a safe experience so they can practice their exercises using gamification features integrated into the VR system, while remaining aware of their surroundings. According to the most recently published studies, there is promising evidence regarding the use of home-based exercises in stroke management especially after the Covid-19 pandemic. However, there is still a gap in identifying the evidence for using non-immersive home-based virtual reality exercises as telerehabilitation on the upper limb function and balance motor outcomes, adherence, and compliance with rehabilitation programs. In addition, no study have evaluated the validity and fidelity of the gamified features that can be added to the non-immersive VR exercises in terms of improving patient adherence and experience to their rehabilitation program. Moreover, the investigators still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years old.

• Having stroke for more than 6 months (early or late chronic stage).

• Not participating in any other rehabilitation study.

• Able to read in English.

• Has good internet connection at home, or can the investigator give them a sim card.

• Score ≤2 on the Modified Ashworth Scale.

• Any degree of upper limb impairment due to stroke (Fugl-Meyer Assessment (FMA)-UE score \<57).

• Having sufficient space at home.

• The participant should have a laptop, computer at their home, if they don't have any of that, the investigator can loan them a laptop.

Locations
Other Locations
United Kingdom
University of Exeter
RECRUITING
Exeter
Contact Information
Primary
Hatem YM lazem, Msc
hl756@exeter.ac.uk
+447436959585
Backup
Helen Dawes, PhD
h.dawes@exeter.ac.uk
07934675772
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2025-06
Participants
Target number of participants: 30
Treatments
Experimental: Non-immersive virtual reality intervention
The experimental group will receive the NOVEL (NOn-immersive Virtual reality Exercises for for upper Limb function and balance) program. This adapted program consists of 4 different non-immersive home-based virtual reality exercise games tailored for upper limb and static balance training combined with motivational strategies (performance feedback, automated progression, exercise gamification) and previously used with non-stroke populations. A videoconferencing or phone call session will be done with the main researcher once per week (Asynchronous with the sessions) to check for any technical difficulties, monitor the progression of the exercises and the progression of the difficulty levels).~Dose of exercises: the participant will have to use the exercise platforms for a minimum of 1 hour per day for 5 days per week. The total period of the intervention will be 8 weeks.
No_intervention: Usual care
Stroke survivors assigned to the control group will continue to receive their usual care in accordance with local policies and practices. Usually, there is no available formal rehabilitation protocol for stroke survivors in the chronic stage of their recovery , but they are considered for long-term management and secondary prevention. No attempt will be made to discourage the provision of additional care, to ensure that usual care is provided. As part of the usual care trial, patients' activity records will be monitored by the researcher, in order to record any stroke care that can be provided to the patients during the trial period.
Related Therapeutic Areas
Sponsors
Collaborators: Cairo University
Leads: University of Exeter

This content was sourced from clinicaltrials.gov