Spinal Muscular Atrophy (SMA)NCT07578454
VRehab-SMA Phase 1.2
A study testing VRehab SMA device in people with Spinal Muscular Atrophy (SMA), run by University of Oxford at 1 site in United Kingdom.
Trial 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 . Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spinal Muscular Atrophy (SMA)
- What is being tested?
- VRehab SMA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Any acute or chronic condition which, according to the investigator, significantly interferes with the use of the device (example: Upper limbs injuries interfering with technology, skin conditions preventing the use of electrodes, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept
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.
Read the detailed description
Spinal muscular atrophy is a genetic disorder where muscles progressively weaken, severely impacting patients' motor abilities eg sitting or walking etc.
Several disease modifying therapies have been developed to treat Spinal muscular atrophy which have led to new disease pathways. For example, previously patients who could not sit can now sit but still not walk. 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 in a recent survey, of patients with Spinal muscular atrophy, only 20% report access to endurance exercises and only 6% report mixed exercises. This is due to manpower limitation and difficulties in engaging with young and sometimes highly disabled children.
To address this, 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 caregivers to facilitate daily exercises in a more accessible and enjoyable manner. This technology would involve the integration of augmented electromyography signals and soft robotic haptic devices into a game controlled by exercise/movement for children. By increasing the frequency and quality of exercise interventions at home, this technology has the potential to significantly address the critically unmet need for consistent rehabilitation and decrease the burden of hospital-based assessments.
This is a proof of concept study to assess patients with Spinal muscular atrophy desire to use the equipment and the potential benefit this can bring to patients by surveying Spinal muscular atrophy patients about technology and exercise and testing the current equipment in a lab setting.
- Conditions
- Spinal Muscular Atrophy (SMA)
- Being tested
- VRehab SMA device
- Keywords
- Spinal Muscular Atrophy
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRehab SMA deviceDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1(Survey) | No intervention | Participants 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) | Experimental | Cohort 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 Receives: Device: VRehab SMA device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
- The perceived impact of VRehab SMA device on motor skills using the approved Relevance questionnaire
Measured: 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
Satisfaction/experience questionnaire. Each participant will be asked to rate:
- Feedback on device
- Usability
- Areas of improvement
Measured: through study completion an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start27 May 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular Atrophy (SMA)Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1 (Survey) A decentralized and qualitative study that aims to gather data via a survey from participants (minimum N=120) formulated from a combined paediatrics SMA and SMA caregiver population. Cohort 2 (Testing) A prospective and observational study on a total of (N=12) paediatric SMA participants that will partake in testing the VRehab SMA device in a controlled environment.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578454
- Sponsor's protocol ID
- Vrehab- PID19470
- Other IDs
- 26/PR/0281
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept
- ClinicalTrials.gov ID
- NCT07578454
- Acronym / sponsor ID
- Vrehab- PID19470
- Conditions
- Spinal Muscular Atrophy (SMA)
- Keywords
- Spinal Muscular Atrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal muscular atrophy is a genetic disorder where muscles progressively weaken, severely impacting patients' motor abilities eg sitting or walking etc.
Several disease modifying therapies have been developed to treat Spinal muscular atrophy which have led to new disease pathways. For example, previously patients who could not sit can now sit but still not walk. 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 in a recent survey, of patients with Spinal muscular atrophy, only 20% report access to endurance exercises and only 6% report mixed exercises. This is due to manpower limitation and difficulties in engaging with young and sometimes highly disabled children.
To address this, 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 caregivers to facilitate daily exercises in a more accessible and enjoyable manner. This technology would involve the integration of augmented electromyography signals and soft robotic haptic devices into a game controlled by exercise/movement for children. By increasing the frequency and quality of exercise interventions at home, this technology has the potential to significantly address the critically unmet need for consistent rehabilitation and decrease the burden of hospital-based assessments.
This is a proof of concept study to assess patients with Spinal muscular atrophy desire to use the equipment and the potential benefit this can bring to patients by surveying Spinal muscular atrophy patients about technology and exercise and testing the current equipment in a lab setting.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort 1 (Survey) A decentralized and qualitative study that aims to gather data via a survey from participants (minimum N=120) formulated from a combined paediatrics SMA and SMA caregiver population. Cohort 2 (Testing) A prospective and observational study on a total of (N=12) paediatric SMA participants that will partake in testing the VRehab SMA device in a controlled environment.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1(Survey) | No intervention | –Participants 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) | Experimental | Device: VRehab SMA deviceCohort 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Any acute or chronic condition which, according to the investigator, significantly interferes with the use of the device (example: Upper limbs injuries interfering with technology, skin conditions preventing the use of electrodes, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRehab SMA deviceThe 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) | Device | Cohort 2 (Testing) |
Primary outcome
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.
Time frame: At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
Responses to survey
Cohort 2 (Testing) To evaluate the relevance of a virtual rehabilitation interface for treated patients with SMA
Time frame: through study completion an average of 6 months
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
1 secondary outcome
Cohort 2 (Testing) - To evaluate the satisfaction/experience of a virtual rehabilitation interface for treated patients with SMA
Time frame: through study completion an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRehab SMA device in people with Spinal Muscular Atrophy (SMA), run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At the end of 3 months (+ extension if needed) or completion of 120 surveys in total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.