VRehab-SMA Phase 1.2

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity of Oxford

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Genetically confirmed SMA

A comprehensive understanding of English

Treated with any disease-modifying therapy post-symptomatically

Number of SMN2 copies available

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Cohort 1(Survey)No intervention 0 interventions
Group B: Cohort 2 (Testing)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
2

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

Time frame
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: 1. Feedback on device 2. Usability 3. Areas of improvement

Time frame
through study completion an average of 6 months

Other outcomes

1

Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 1

1\. Outcome measures used as anchors: a, Revised upper limb module (RULM): Total score and range of motion as measured by motion capture cameras at V1 and compared with range of motion captured during the use of VRehab SMA device

Time frame
through study completion an average of 6 months
2

Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 2

Myogrip: measured strength value and compare with strength captured during the use of VRehab SMA device

Time frame
through study completion an average of 6 months
3

Cohort 2 (Testing) Exploratory objectives -To assess signals of hand strength changes (fatigue).

A Comparison of the pattern and range of maximum grip strength (maximum voluntary contraction (MVC) between the first few visit trials and last few visit trials

Time frame
through study completion an average of 6 months

Sponsors and contacts

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