NCT06274983

DMD- Interactive Virtual Reality Study

Investigating the Viability and Acceptability of an Interactive Virtual Reality (IVR) System on Physiotherapy Rehabilitation in Paediatric Duchenne Muscular Dystrophy (DMD) Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sheffield Children's NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This study will help determine if an Interactive Virtual Reality system can improve the physiotherapy of young patients with Duchenne muscular dystrophy (DMD).

Detailed description

Duchenne Muscular Dystrophy (DMD) is a genetic disease causing muscle weakness and wasting affecting 2,500 people in the UK. International Standards of Care recommend that children with DMD undertake a daily stretching programme to maintain maximum muscle extensibility and optimise function. A lot of children are not motivated to perform these exercises, leading to earlier complications, reduced function and a poorer long-term prognosis. Our collaborative research group has previously developed an interactive Immersive Virtual Reality (IVR) system to improve the delivery, engagement and success of physiotherapy for adult amputees, burns' patients and children with upper limb injuries. VR headsets have become more accessible in terms of price, usability and portability. In a recent PPI survey, 78% of paediatric DMD patients stated that a VR system could improve physiotherapy engagement and performance. This study will investigate the feasibility and acceptability of an IVR device on paediatric DMD rehabilitation. In phase 1 of this study, clinicians, physiotherapists, parents, carers and patients will participate in a co-design workshop to explore core VR rehabilitation scenarios. An IVR platform will be developed that will emulate current DMD physiotherapy. In phase 2, investigators will ask therapists and children to take part in testing the IVR platform. VR scenarios will be further developed and then tested in a trial with 16 DMD patients aged 5-10 years. Pre and post-trial assessments will be performed to determine the effect of the IVR system on improving physiotherapy adherence, muscle strength testing, quality of life and anxiety. Qualitative interviews and questionnaires will be conducted with patients and clinical staff to obtain feedback on patient acceptability as well as practicality and acceptability of using IVR in a clinical setting. This study will help determine if an IVR system can improve the physiotherapy of young patients with DMD.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DEVICE	IVR platform trial	8 DMD patients from Sheffield Children's Hospital and 8 DMD patients from Leeds Teaching Hospital to trial the IVR platform. Patients will receive device training and then use the VR device at home for 12 weeks. Physiotherapists will conduct pre (visit 1) and post (visit 2) assessments to assess changes using a Goniometer (measures ankle range of movement), PEDSQL quality of life data, GAD-7 anxiety questions and the NorthStar Ambulatory Assessment.

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2024-02-23
• Last updated: 2024-02-26

Locations

1 site across 1 country: United Kingdom