Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
14 participants
INTERVENTIONAL
2023-04-20
2024-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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IVR platform trial
8 DMD patients from Sheffield Children's Hospital and 8 DMD patients from Leeds Teaching Hospital to trial the IVR platform.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Duchenne muscular dystrophy (DMD) and receiving lower limb physiotherapy care
* Ambulant patients
* Able to speak/understand English
Exclusion Criteria
* 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.
5 Years
10 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Sheffield Hallam University
OTHER
UCL Great Ormond Street Institute of Child Health
OTHER
Leeds General Infirmary
UNKNOWN
Sheffield Children's NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Sheffield Childrens NHS FT
Sheffield, South Yorkshire, United Kingdom
Countries
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Other Identifiers
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SCH-2629
Identifier Type: -
Identifier Source: org_study_id
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