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ACTIVE NOT RECRUITINGNA

VRehab-SMA Phase 1.2

Sponsor: University of Oxford

NCT ID: NCT07578454

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
VRehab SMA device (device)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
VRehab SMA device — device: 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)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
6 Years to 18 Years
Who
All
Number of participants
12
Started
2026-05-27
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for spinal muscular atrophy (sma)
  • • NA - 12 participants
  • • Spinal muscular atrophy is a genetic disorder characterized by progressive muscle weakness, severely impacting patients' motor abilities

Who can take part?

  • • Ages 6 Years to 18 Years
  • • Diagnosed with spinal muscular atrophy (sma)

Where?

  • • Oxford - Oxford University

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Spinal Muscular Atrophy (SMA)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Years - 18 Years
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗No exclusion criteria for Cohort 1, other than meeting the inclusion criteria
  • ✗Cohort 2 Inclusion Criteria:
  • ✗Participant with SMA aged 6-10 years
  • ✗Genetically confirmed SMA
  • ✗A comprehensive understanding of English
See the full criteria
Cohort 1 Inclusion Criteria: * 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 Exclusion Criteria: No exclusion criteria for Cohort 1, other than meeting the inclusion criteria Cohort 2 Inclusion Criteria: 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 * Age: Participants between 6-10 years at Visit 1 (inclusion) * 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 * Age: Participants between 11-15 years at Visit 1 (inclusion) * 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 * Genetically confirmed SMA * A comprehensive understanding of English * Treated with any disease-modifying therapy post-symptomatically * Number of SMN2 copies available * Functional status available * Age: Participants between 16-18 years at Visit 1 (inclusion) * Able to provide written informed consent Exclusion Criteria: 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)

Where Is This Study? (1 UK site)

Oxford University

Oxford, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---
Data sourced from ClinicalTrials.gov · Last verified: 2026-04