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

May 9, 2024 updated by: Rosa Baeza Barragán, University of Malaga
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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain, 29071
        • Universidad de Málaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: 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.
Active Comparator: Traditional physiotherapy program
Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.
Other: traditional physiotherapy program
Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.

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
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.
Baseline, up to six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EPInfant
Time Frame: through study completion, average 6 weeks
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.
through study completion, average 6 weeks
NSAA o North Star Ambulatory Assessment
Time Frame: Baseline, up to 6 weeks

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
MFM o Motor Function Measure
Time Frame: Baseline, up to 6 weeks
measure motor performance
Baseline, up to 6 weeks
Kids Screen-52
Time Frame: Baseline.
quality of life test
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Study Director: Maria Teresa Labajos Manzanares, PhD, Universidad de Málaga
  • Study Director: Rocío Martín Valero, PhD, Universidad de Málaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

March 11, 2023

Study Registration Dates

First Submitted

March 9, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMalagaRV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

an average of 2 years

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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