VRehab-SMA Phase 1.2
Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept
2 other identifiers
interventional
12
1 country
1
Brief Summary
Spinal muscular atrophy is a genetic disorder characterized by progressive muscle weakness, severely impacting patients' motor abilities. Several disease modifying therapies have been developed to treat Spinal muscular atrophy which have led to new disease trajectories . According to standard of care guidelines, exercise programs should be designed and monitored by a physical therapist and should include exercises to improve daily life activities. Exercises should be adapted to each patient and can be prescribed with an optimal frequency in various ways. However, of patients with Spinal muscular atrophy, only 20% reported access to endurance exercises and only 6% to mixed exercises. This incompliance to standard of care guidelines is due to manpower limitation and difficulties in engaging with young and sometimes highly disabled children. Our group has been pioneering in developing the UK at-home individualised rehabilitation program. To address this challenge, the Investigators propose the development of an innovative, virtual targeted rehabilitation platform specifically designed for young patients with Spinal muscular atrophy. This technology aims to provide a patient-centric, at-home rehabilitation solution, enabling parents/caregivers to facilitate daily exercises in a more accessible and enjoyable manner. This technology would constitute the first of its kind in Spinal muscular atrophy field, involving the integration of augmented electromyography signals and soft robotic haptic devices into a gamified virtual reality environment. By increasing the frequency and quality of exercise interventions at home, this technology has the potential to significantly address the critical unmet need for consistent rehabilitation. This technology will also serve as a clinical outcome measure for continuous home-based assessments of weaker and less functional population in place of hospital-based assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
May 11, 2026
CompletedStudy Start
First participant enrolled
May 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
June 11, 2026
April 1, 2026
10 months
April 15, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cohort 1 (Survey) - To understand current user engagement with exercises and digital games (including time spent and game types) in order to identify and propose suitable activities, games, and tasks for inclusion in the VRehab interface.
Responses to survey
At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
Cohort 2 (Testing) To evaluate the relevance of a virtual rehabilitation interface for treated patients with SMA
Number of patients who rate the device as relevant. Each participant will be asked to rate: a. The perceived impact of VRehab SMA device on motor skills using the approved Relevance questionnaire
through study completion an average of 6 months
Secondary Outcomes (1)
Cohort 2 (Testing) - To evaluate the satisfaction/experience of a virtual rehabilitation interface for treated patients with SMA
through study completion an average of 6 months
Other Outcomes (3)
Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 1
through study completion an average of 6 months
Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 2
through study completion an average of 6 months
Cohort 2 (Testing) Exploratory objectives -To assess signals of hand strength changes (fatigue).
through study completion an average of 6 months
Study Arms (2)
Cohort 1(Survey)
NO INTERVENTIONParticipants will be asked to complete and online survey with 17 questions (with subparts). The first 4 questions will establish their Spinal muscular atrophy condition and their movement levels. The remaining 13 questions will establish their exercise routines and use of technology in daily life. Followed by their preference for gaming, types of games and TV programs they enjoy. The participants will only be asked once to fill in the survey and this will be carried out at their own homes on their own.
Cohort 2 (Testing)
EXPERIMENTALCohort 2 (Testing) will test out a basic device in a control laboratory environment to determine if further research for long term use and a at home device would be beneficial to patients and not have any adverse effects to their physical health. Participants will be ask to attend a pre-screening video to check eligibility for the study and be consented online at the meeting. Following this meeting 2 visits will be arranged at the University Biomedical engineering lab in Oxford and the participants asked to participate in using the device
Interventions
The VRehab SMA device includes: * A screen to provide visual feedback (like games or animations) * Bluetooth-connected EMG sensors to measure muscle activity in the arms * A ball to measure grip strength * A virtual reality (VR) headset (used only for participants over 10 years of age)
Eligibility Criteria
You may qualify if:
- Person with SMA
- A person living with genetically confirmed SMA aged from 12-18 years
- A good understanding of English or someone who can provide a good understanding of English for me to complete the survey
- A young person living with SMA from 12-15 years of age and who's caregiver/legal guardian gives consent
- A young person living with SMA from 16-18 years of age who provide their own consent
- Caregiver/ Legal Guardian
- A caregiver (legal guardian) of child/young person living with SMA aged from 6-18 years old
- A good understanding of English or someone who can provide a good understanding of English for me to complete the survey
You may not qualify if:
- Participant with SMA aged 6-10 years
- Genetically confirmed SMA
- A comprehensive understanding of English
- Treated with any disease-modifying therapy post-symptomatically
- Number of SMN2 copies available
- Functional status available
- Parent(s)/legal guardian(s)/caregiver(s) able to provide written informed consent and child able to provide assent prior to participation in the study
- Participant with SMA aged 11-15 years
- Genetically confirmed SMA
- A comprehensive understanding of English
- Treated with any disease-modifying therapy post-symptomatically
- Number of SMN2 copies available
- Functional status available
- Parent(s)/legal guardian(s)/caregiver(s) able to provide written informed consent and child able to provide assent prior to participation in the study
- Participant with SMA aged 16-18 years
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford University
Oxford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2026
First Posted
May 11, 2026
Study Start
May 27, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 11, 2026
Record last verified: 2026-04