Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.

NCT ID: NCT03879304

Last Updated: 2024-05-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-03-11

Brief Summary

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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

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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.

Conditions

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Muscular Dystrophy, Duchenne and Becker Types

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

multimodal physiotherapy program with RV

Intervention Type OTHER

Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.

Traditional physiotherapy program

Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.

Group Type ACTIVE_COMPARATOR

traditional physiotherapy program

Intervention Type OTHER

Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.

Interventions

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multimodal physiotherapy program with RV

Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.

Intervention Type OTHER

traditional physiotherapy program

Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.

Intervention Type OTHER

Eligibility Criteria

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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%.
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Rosa Baeza Barragán

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rocío Martín Valero, PhD

Role: STUDY_DIRECTOR

Universidad de Málaga

Maria Teresa Labajos Manzanares, PhD

Role: STUDY_DIRECTOR

Universidad de Málaga

Locations

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Universidad de Málaga

Málaga, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 33289679 (View on PubMed)

Baeza-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.

Reference Type RESULT
PMID: 37990809 (View on PubMed)

Other Identifiers

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UMalagaRV

Identifier Type: -

Identifier Source: org_study_id

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