Clinical trial NCT06274983: DMD- Interactive Virtual Reality Study
Official title: Investigating the Viability and Acceptability of an Interactive Virtual Reality (IVR) System on Physiotherapy Rehabilitation in Paediatric Duchenne Muscular Dystrophy (DMD) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Sheffield Hallam University
name: UCL Great Ormond Street Institute of Child Health
name: Leeds General Infirmary
First posted: 2024-02-23
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises.
timeFrame: 8 weeks
measure: Compliance: Ratings of duration of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises.
timeFrame: 8 weeks
measure: Post-trial qualitative interviews on perceptions, acceptability, usability and effectiveness of DMD-IVR device in the context of the family's overall burden of care
timeFrame: 30 minutes
measure: DMD-IVR Effectiveness standard functional assessments: North Star Ambulatory Assessment (NSAA)
timeFrame: 10 minutes
measure: DMD-IVR effectiveness measures with a Timed test 4 stair climb
timeFrame: 10 minutes
measure: DMD-IVR effectiveness measured joint range of movement using Goniometer (Standard BASELINE® 12-inch)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Childrens NHS FT
state: South Yorkshire
Study officials:
References: