DMD- Interactive Virtual Reality Study

NCT06274983 | Completed

• 1 other identifier: SCH-2629
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (6)

• Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises.

  The physiotherapy team prescribe a defined frequency for use individualised for each child. Pre and Post Home diary: Families will be asked to complete a paper/electronic diary to capture compliance with current physio regime (including frequency of stretching and other activities for a 4 week 'pre intervention' period). The system will log the frequency of use of the DMD-VR platform during the 8 weeks (quantitative) which will be cross referenced with the patient completed activity diary.

  8 weeks

• Compliance: Ratings of duration of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises.

  The physiotherapy team prescribe a defined time for use individualised for each child. Pre and Post Home diary: Families will be asked to complete a paper/electronic diary to capture compliance with current physio regime (including duration of stretching and other activities for a 4 week 'pre intervention' period). The system will log the duration of use of the DMD-VR platform during the 8 weeks (quantitative) which will be cross referenced with the patient completed activity diary.

  8 weeks

• 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

  A semi-structured interview will be conducted by the research nurse in person/phone with the patient and parent after the DMD-IVR rehabilitation at home trial (8 week). Open-ended questions provided qualitative data relating to acceptability, practicality, difficulty, pain and enjoyability, and participant attitudes towards the IVR system and its future deployment. Another semi-structured interview was conducted with the clinical staff by the researcher in person at the end of the trial to explore her attitudes towards the DMD-IVR device and future deployment (8 week). Both interviews were recorded, transcribed and anonymised.

  30 minutes

• DMD-IVR Effectiveness standard functional assessments: North Star Ambulatory Assessment (NSAA)

  NSAA is a 17-item rating scale used to measure functional motor abilities in ambulant children with DMD. The test must be completed without the use of any thoracic brace or leg orthoses. Therapist asks the patient to complete activities listed below. The activities are graded as follows: 2 - "Normal" - no obvious modification of activity 1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function. Several studies have shown that NSAA is a quick, specific, reliable, valid, and clinically relevant method to measure the functional motor ability of ambulant children with DMD. NSAA is considered to be suitable to be used in research and in a multicentric setting provided that adequate training is given. \[https://www.physio-pedia.com/North\_Star\_Ambulatory\_Assessment\] Evaluation at the baseline

  10 minutes

• DMD-IVR effectiveness measures with a Timed test 4 stair climb

  Evaluation at the baseline screening visit by the physiotherapist and at the end of the study (week 8).

  10 minutes

• DMD-IVR effectiveness measured joint range of movement using Goniometer (Standard BASELINE® 12-inch)

  Goniometer device (Standard BASELINE® 12-inch plastic goniometer, (Model 12- 1000-Fabrication Enter- prises, Inc: White Plains, New York) will be use by the clinical staff before and after the patient's rehabilitation to document the initial and subsequent range of motion, evaluate their progress and to determine the level of disability. Clinical staff used the goniometer. To assess any changes in range of movement using goniometer measured ankle range of movement, plus any other joint range of movement physiotherapist deemed clinically valuable. The clinical team examined the differences between a range of movements join (flexion, extension, abduction, and adduction) before and after the VR rehabilitation. The greater the range of movement the better. Evaluation at the baseline screening visit by the physiotherapist and at the end of the study (week 8).

  10 minutes

Study Arms (1)

IVR platform trial

OTHER

8 DMD patients from Sheffield Children's Hospital and 8 DMD patients from Leeds Teaching Hospital to trial the IVR platform.

Device: IVR platform trial

Interventions

IVR platform trial DEVICE

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.

IVR platform trial

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Sheffield Hallam University: collaborator
• UCL Great Ormond Street Institute of Child Health: collaborator
• Leeds General Infirmary: collaborator

Study Sites (1)

Sheffield Childrens NHS FT

Sheffield, South Yorkshire, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: February 23, 2024
• Study Start: April 20, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 20, 2026

Record last verified: 2025-05

Locations

GB (1)