NOVEL Program for Stroke Telerehabilitation

NCT06409598 | Completed

• 1 other identifier: Stroke Telerehabilitation
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Stroke

Keywords

virtual reality; Telerehabilitation; Qualitative; Feasibility

Outcome Measures

Primary Outcomes (6)

• Proportion of eligible participants out of screened participants

  Total number of participants who pass the screening phase.

  During the screening process

• Proportion of ineligible participants out of screened patients

  Total number of participants who are ineligible with their reasons.

  During the screening process

• Success rate of obtaining consent from those eligible participants

  Number of participants enrolled/randomised

  During the enrolment process

• Retention rate of the participants

  Retention rate is defined as proportion of people that finished the exercise programme after 8 weeks. Retention data will be assessed based on (i) proportion of participants with complete outcome assessment; (ii) number of discontinuation and reasons.

  Recorded at week 8 at the end of delivering the intervention.

• Adherence of the participants

  Adherence is defined as the number and proportion of scheduled sessions undertaken by the participants.

  Recorded at week 8 at the end of delivering the intervention.

• Total number of adverse events reported by the participants using their workbook.

  Adverse events are any unfavourable experiences reported by participants during the study (regardless of whether these were related to the intervention). Participants in intervention and control groups will be asked to report any adverse events throughout the intervention period in their workbook and report any adverse effect to the researcher during the weekly meeting.

  Recorded at week 8 at the end of delivering the intervention.

Secondary Outcomes (10)

• Change from baseline in upper limb function on Fugl-Meyer Assessment for Upper Extremity (FMA-UE) test at week 8.

  Completed at baseline and 8 weeks after receiving the intervention or the usual care.

• Change from baseline in upper limb function on action research arm test (ARAT) at week 8.

  Completed at baseline and 8 weeks after receiving the intervention or the usual care.

• Change from baseline in upper limb function on The Motor Activity Log test at week 8.

  Completed at baseline and 8 weeks after receiving the intervention or the usual care.

• Change from baseline in balance confidence on Activities-Specific Balance Confidence(ABC) scale at week 8.

  Completed at baseline and 8 weeks after receiving the intervention or the usual care.

• Change from baseline in trunk control on Trunk Impairment Scale (TIS) at week 8.

  Completed at baseline and 8 weeks after receiving the intervention or the usual care.

Study Arms (2)

Non-immersive virtual reality intervention

EXPERIMENTAL

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.

Other: Non-immersive virtual reality home-based exercise.

Usual care

NO INTERVENTION

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.

Interventions

Non-immersive virtual reality home-based exercise. OTHER

This intervention aims include some exercises in the form of games to facilitate and improve the upper limb functions and static balance from sitting and standing positions among chronic stroke survivors.

Non-immersive virtual reality intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having severe arm, leg, or spine contractures, or deformities (MAS 3 or 4).
• Having any medical contraindications (seizure disorders, symptomatic shoulder subluxation, artificial cardiac pacemaker device, persistent shoulder pain (\> 5 on VAS scale as an average).
• 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.
• 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.
• Insufficient motor control to move the avatar on the screen.
• Concurrent enrolment in another investigational study.
• Pregnancy (self reported).

Sponsors & Collaborators

• University of Exeter: lead
• Cairo University: collaborator

Study Sites (1)

University of Exeter

Exeter, EX1 2LU, United Kingdom

Location

Study Officials

• Helen Dawes

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded from knowing if the participant assigned to the experimental or the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: July 31, 2024
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)