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DMD- Interactive Virtual Reality Study (DMD-IVR)

NHS Foundation Trust logo

NHS Foundation Trust

Status

Active, not recruiting

Conditions

Duchenne Muscular Dystrophy

Treatments

Device: IVR platform trial

Study type

Interventional

Funder types

Other

Identifiers

NCT06274983
SCH-2629

Details and patient eligibility

About

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

Full 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.

Enrollment

14 patients

Sex

All

Ages

5 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 5-10 years
  • Diagnosed with Duchenne muscular dystrophy (DMD) and receiving lower limb physiotherapy care
  • Ambulant patients
  • Able to speak/understand English

Exclusion criteria

  • Physical or cognitive difficulties indicating the child would struggle to use the device or complete study activities.
  • Outside age range.
  • Non-ambulant patients.
  • Facial injuries precluding the use of HMD.
  • Issues relating to balance that could be affected by VR.
  • Severe visual impairment.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

IVR platform trial
Other group
Description:
8 DMD patients from Sheffield Children's Hospital and 8 DMD patients from Leeds Teaching Hospital to trial the IVR platform.
Treatment:
Device: IVR platform trial

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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