NCT06409598Completed
NOVEL Program for Stroke Telerehabilitation
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.
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 7 May 2024
- Start date
- 31 Jul 2024
- Primary completion date
- 28 Apr 2026
- Lead sponsor
- University of Exeter
- Diseases
- Stroke
- NCT number
- NCT06409598
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From 31 Jul 2024 to the primary completion date, 28 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- To avoid potential confounding effects associated with other treatments, patients with any history of virtual reality upper-limb training or who received a botulinum toxin injection within 16 weeks before enrolment will be excluded.
- Concurrent enrolment in another investigational study.
Other illness
- Having any medical contraindications (seizure disorders, symptomatic shoulder subluxation, artificial cardiac pacemaker device, persistent shoulder pain (\> 5 on VAS scale as an average).
Other
- Having severe arm, leg, or spine contractures, or deformities (MAS 3 or 4).
- To ensure patients had sufficient cognitive abilities to participate in training and evaluation and to provide informed consent, the investigators will exclude patients diagnosed with - serious aphasia (cannot read the instructions) or cognitive dysfunction (inability to understand and follow two-stage instructions given by the investigators.
- Insufficient motor control to move the avatar on the screen.
- Pregnancy (self reported).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Exeter Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.