RecruitingNot ApplicableNCT07578454

VRehab-SMA Phase 1.2

Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept


Sponsor

University of Oxford

Enrollment

12 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria32

  • 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
  • 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 Criteria1

  • 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)

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Interventions

DEVICEVRehab SMA 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)


Locations(1)

Oxford University

Oxford, United Kingdom

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NCT07578454


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