Muscular Dystrophy, Duchenne and Becker TypesRVDuchenneNCT03879304
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
A study testing multimodal physiotherapy program with RV and traditional physiotherapy program in people with Muscular Dystrophy, Duchenne and Becker Types, run by University of Malaga at 1 site in Spain.
Trial summary
Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking test, is used for determine the inclusion of children with DMD in pharmacological studies. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Muscular Dystrophy, Duchenne and Becker Types
- What is being tested?
- multimodal physiotherapy program with RV and traditional physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2021to 11 Mar 2023
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- An other Dystrophies.
- Older than 10 years.
- Not Physiotherapy. Not walk.
- Asociated heart disease Sprains, fractures. FC >120, Sat O2 <89%.
Trial locations and contacts
1 site in 1 country.
About this study
Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking test, is used for determine the inclusion of children with DMD in pharmacological studies. Furthemore, is used to verify a training effectiveness assessing muscular endurance and cardio-respiratory functions. This Research evaluates the feasibility and effectiveness of a multimodal physiotherapist program with virtual reality glasses.
Read the 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.
- Being tested
- multimodal physiotherapy program with RV, traditional physiotherapy program
- 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]
- 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.
multimodal physiotherapy program with RVOther
Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.
traditional physiotherapy programOther
Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal physiotherapy program with RV | Experimental | 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. Receives: Other: multimodal physiotherapy program with RV |
| Traditional physiotherapy program | Active comparator | Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses. Receives: Other: traditional physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in six meter walking test (6-MWT) score
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.
Measured: Baseline, up to six weeks
Secondary outcomes (4)
EPInfant
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.
Measured: through study completion, average 6 weeks
NSAA o North Star Ambulatory Assessment
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.
Measured: Baseline, up to 6 weeks
MFM o Motor Function Measure
measure motor performance
Measured: Baseline, up to 6 weeks
Kids Screen-52
quality of life test
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start15 Mar 2021
- Primary completion30 Oct 2022
- Study completion11 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscular Dystrophy, Duchenne and Becker TypesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Twelve participants were randomized to follow a multimodal physiotherapy program for 6 weeks. At the end of this period the participants will be crossed to another intervention without virtual reality glasses. The results will be measured before and after each intervention during the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Baeza Barragán, University of Malaga
- Investigators
- Rocío Martín Valero, PhD, Study director, Universidad de MálagaMaria Teresa Labajos Manzanares, PhD, Study director, Universidad de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879304
- Sponsor's protocol ID
- UMalagaRV
- Acronym
- RVDuchenne
- Status last verified
- May 2024
- First submitted
- 9 Mar 2019
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: an average of 2 years
Publications
Baeza-Barragan MR, Labajos Manzanares MT, Ruiz Vergara C, Casuso-Holgado MJ, Martin-Valero R. The Use of Virtual Reality Technologies in the Treatment of Duchenne Muscular Dystrophy: Systematic Review. JMIR Mhealth Uhealth. 2020 Dec 8;8(12):e21576. doi: 10.2196/21576.
PubMed 33289679Baeza-Barragan MR, Labajos Manzanares MT, Amaya-Alvarez MC, Morales Vega F, Rodriguez Ruiz J, Martin-Valero R. Effectiveness of a 5-Week Virtual Reality Telerehabilitation Program for Children With Duchenne and Becker Muscular Dystrophy: Prospective Quasi-Experimental Study. JMIR Serious Games. 2023 Nov 15;11:e48022. doi: 10.2196/48022.
PubMed 37990809
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
- ClinicalTrials.gov ID
- NCT03879304
- Acronym / sponsor ID
- RVDuchenne / UMalagaRV
- 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]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 11 Mar 2023 (actual)
- First posted
- 18 Mar 2019 (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.
Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking test, is used for determine the inclusion of children with DMD in pharmacological studies. Furthemore, is used to verify a training effectiveness assessing muscular endurance and cardio-respiratory functions. This Research evaluates the feasibility and effectiveness of a multimodal physiotherapist program with virtual reality glasses.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Twelve participants were randomized to follow a multimodal physiotherapy program for 6 weeks. At the end of this period the participants will be crossed to another intervention without virtual reality glasses. The results will be measured before and after each intervention during the study.
| Arm | Type | Receives |
|---|---|---|
| Multimodal physiotherapy program with RV | Experimental | Other: multimodal physiotherapy program with RVThe 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. |
| Traditional physiotherapy program | Active comparator | Other: traditional physiotherapy programTraditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- An other Dystrophies.
- Older than 10 years.
- Not Physiotherapy. Not walk.
- Asociated heart disease Sprains, fractures. FC >120, Sat O2 <89%.
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 |
|---|---|---|
| multimodal physiotherapy program with RVPhysiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation. | Other | Multimodal physiotherapy program with RV |
| traditional physiotherapy programMultimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage. | Other | Traditional physiotherapy program |
Primary outcome
Changes in six meter walking test (6-MWT) score
Time frame: Baseline, up to six weeks
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.
4 secondary outcomes
EPInfant
Time frame: through study completion, average 6 weeks
NSAA o North Star Ambulatory Assessment
Time frame: Baseline, up to 6 weeks
MFM o Motor Function Measure
Time frame: Baseline, up to 6 weeks
Kids Screen-52
Time frame: Baseline.
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 13 May 2024.
- Background: PubMed 33289679Baeza-Barragan MR, Labajos Manzanares MT, Ruiz Vergara C, Casuso-Holgado MJ, Martin-Valero R. The Use of Virtual Reality Technologies in the Treatment of Duchenne Muscular Dystrophy: Systematic Review. JMIR Mhealth Uhealth. 2020 Dec 8;8(12):e21576. doi: 10.2196/21576.
- Results publication: PubMed 37990809Baeza-Barragan MR, Labajos Manzanares MT, Amaya-Alvarez MC, Morales Vega F, Rodriguez Ruiz J, Martin-Valero R. Effectiveness of a 5-Week Virtual Reality Telerehabilitation Program for Children With Duchenne and Becker Muscular Dystrophy: Prospective Quasi-Experimental Study. JMIR Serious Games. 2023 Nov 15;11:e48022. doi: 10.2196/48022.
- Individual participant dataSharing planned: No. an average of 2 years
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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.
Rocío Martín Valero, PhD study director
Universidad de Málaga
Maria Teresa Labajos Manzanares, PhD study director
Universidad de Málaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal physiotherapy program with RV and traditional physiotherapy program in people with Muscular Dystrophy, Duchenne and Becker Types, run by University of Malaga at 1 site in Spain.
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 4 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 13 May 2024. 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 Spain. 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?
Changes in six meter walking test (6-MWT) score (time frame: Baseline, up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879304, which also lists 2 linked publications.
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 13 May 2024.