Duchenne Muscular DystrophyDMD-IVRNCT06274983
DMD- Interactive Virtual Reality Study
A study testing IVR platform trial in people with Duchenne Muscular Dystrophy, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will help determine if an Interactive Virtual Reality system can improve the physiotherapy of young patients with Duchenne muscular dystrophy (DMD). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- IVR platform trial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5-10 years
- Diagnosed with Duchenne muscular dystrophy (DMD) and receiving lower limb physiotherapy care
- Ambulant patients
- Able to speak/understand English
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Childrens NHS FT
Sheffield, South Yorkshire, S10 2TH
About this 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
This study will help determine if an Interactive Virtual Reality system can improve the physiotherapy of young patients with Duchenne muscular dystrophy (DMD).
Read the 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
- Being tested
- IVR platform trial
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR platform trialDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IVR platform trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 Apr 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Sheffield Hallam University, UCL Great Ormond Street Institute of Child Health, Leeds General Infirmary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274983
- Sponsor's protocol ID
- SCH-2629
- Acronym
- DMD-IVR
- Status last verified
- May 2025
- First submitted
- 6 Jun 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Viability and Acceptability of an Interactive Virtual Reality (IVR) System on Physiotherapy Rehabilitation in Paediatric Duchenne Muscular Dystrophy (DMD) Patients
- ClinicalTrials.gov ID
- NCT06274983
- Acronym / sponsor ID
- DMD-IVR / SCH-2629
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Sheffield Hallam University, UCL Great Ormond Street Institute of Child Health, Leeds General Infirmary
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVR platform trial | Other | Device: IVR platform trial8 DMD patients from Sheffield Children's Hospital and 8 DMD patients from Leeds Teaching Hospital to trial the IVR platform. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 5-10 years
- Diagnosed with Duchenne muscular dystrophy (DMD) and receiving lower limb physiotherapy care
- Ambulant patients
- Able to speak/understand English
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR platform trial8 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. | Device | IVR platform trial |
Primary outcome
Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises.
Time frame: 8 weeks
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.
Compliance: Ratings of duration of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises.
Time frame: 8 weeks
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.
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
Time frame: 30 minutes
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.
DMD-IVR Effectiveness standard functional assessments: North Star Ambulatory Assessment (NSAA)
Time frame: 10 minutes
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
DMD-IVR effectiveness measures with a Timed test 4 stair climb
Time frame: 10 minutes
Evaluation at the baseline screening visit by the physiotherapist and at the end of the study (week 8).
DMD-IVR effectiveness measured joint range of movement using Goniometer (Standard BASELINE® 12-inch)
Time frame: 10 minutes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
Related trials for Duchenne Muscular Dystrophy
Enrolling by invitationObservational study
An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
RecruitingObservational study
Does Chronic Pain Change Over Time in Children With Duchenne Muscular Dystrophy?
Duchenne Muscular Dystrophy (DMD), Chronic Pain
RecruitingObservational study
Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingPhase 1/2
PBGENE-DMD Phase 1/2a Safety and Preliminary Efficacy Study in Duchenne Muscular Dystrophy (FUNCTION-DMD)
Duchenne Muscular Dystrophy With Mutations Amenable to PBGENE-DMD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR platform trial in people with Duchenne Muscular Dystrophy, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises. (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.