- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879304
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker. (RVDuchenne)
Study Overview
Status
Intervention / Treatment
Detailed Description
In addition a physiotherapy program, virtual reality have a lot of importance advantages for train while motivated the kids.
A cross over study will be applied. In the control time, patient will received a initial evaluation and a final without making the physiotherapy program and without virtual reality glasses. The data will be collected by principal examiner.
In the intervention time the group will received 10 multimodal physiotherapy sessions, two or one per week, along six weeks. Also they are going to training walking with with virtual games.
Multimodal physiotherapist program describes the exercises to be performed, how long it will take, the number of repetitions and the way to do it with the physiotherapist in zoom session.
At the end of the multimodal physiotherapy program, variables will be evaluated by the principal examiner.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Málaga, Spain, 29071
- Universidad de Málaga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between 4 and 15 years
- Duchenne and Becker Diagnosis ICD-10 issued by specialist in neurology.
- Children who can walk 10 m at last 120 seconds.
- First punctuation of North Start Ambulatory assessment bigger than 20 points.
Exclusion Criteria:
- An other Dystrophies.
- Older than 10 years.
- Not Physiotherapy. Not walk.
- Asociated heart disease Sprains, fractures. FC >120, Sat O2 <89%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multimodal physiotherapy program with RV
The RV intervention group receives a tele multimodal physiotherapy program with tradicional exercises of physiotherapy like stretching, aerobic, training through videos and gamification with VR glasses.
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Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.
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Active Comparator: Traditional physiotherapy program
Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.
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Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in six meter walking test (6-MWT) score
Time Frame: Baseline, up to six weeks
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Six-meter walking test is a a well-established outcome measure in a variety of diseases.
It is accurate, reproducible, simple to administer, and well tolerated.
The 6MWT is a robust assessment tool for use in clinical trials given its ability to quantitatively evaluate ambulation in a controlled environment.
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Baseline, up to six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EPInfant
Time Frame: through study completion, average 6 weeks
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Scale of perceived child effort measurement EPInfant.
It shows 11 numerical descriptors (0 to 10), 5 verbal descriptors located every 2 levels of intensity, and a set of illustrations that represent a child running at increasing intensities along a scale of bars of incremental height following a exponential type slope from left to right.
The higher value represent a worse outcome.
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through study completion, average 6 weeks
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NSAA o North Star Ambulatory Assessment
Time Frame: Baseline, up to 6 weeks
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Functional scale for children with DMD. It is expressed in points and evidences the acquisition of functions or the loss of them. Whilst DMD children may generally present with recognizable adaptations to activity due to the underlying progressive muscular weakness, they may modify their activity to achieve functional goals in slightly differing ways. Generally, activities are graded in the following manner: 2 - 'Normal' - no obvious modification of activity 1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently. The better punctuation is 34 point, what mean the higher outcome. |
Baseline, up to 6 weeks
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MFM o Motor Function Measure
Time Frame: Baseline, up to 6 weeks
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measure motor performance
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Baseline, up to 6 weeks
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Kids Screen-52
Time Frame: Baseline.
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quality of life test
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Baseline.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maria Teresa Labajos Manzanares, PhD, Universidad de Málaga
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Virtual Reality [L01.224.160.875], [L01.296.555]
- Physical Therapy Modalities [E02.779], [E02.831.535]
- Respiratory Therapy [E02.880]
- Dystrophin [D12.776.210.500.250]
- Becker Muscular Dystrophy [C10.668.491.175.500.300]
- Resistance training [E02.831.535.483.875]
- Muscular Stretching Therapy [E02.831.535.483.750]
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMalagaRV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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