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

Primary Purpose

Muscular Dystrophy, Duchenne and Becker Types

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
multimodal physiotherapy program with RV
traditional physiotherapy program
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophy, Duchenne and Becker Types focused on measuring 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]

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • Universidad de Málaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal physiotherapy program with RV

Traditional physiotherapy program

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
MFM o Motor Function Measure
measure motor performance
Kids Screen-52
quality of life test

Full Information

First Posted
March 9, 2019
Last Updated
March 11, 2023
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT03879304
Brief Title
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Acronym
RVDuchenne
Official Title
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
March 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophy, Duchenne and Becker Types
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]

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal physiotherapy program with RV
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional physiotherapy program
Arm Type
Active Comparator
Arm Description
Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.
Intervention Type
Other
Intervention Name(s)
multimodal physiotherapy program with RV
Intervention Description
Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.
Intervention Type
Other
Intervention Name(s)
traditional physiotherapy program
Intervention Description
Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.
Primary Outcome Measure Information:
Title
Changes in six meter walking test (6-MWT) score
Description
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.
Time Frame
Baseline, up to six weeks
Secondary Outcome Measure Information:
Title
EPInfant
Description
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.
Time Frame
through study completion, average 6 weeks
Title
NSAA o North Star Ambulatory Assessment
Description
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.
Time Frame
Baseline, up to 6 weeks
Title
MFM o Motor Function Measure
Description
measure motor performance
Time Frame
Baseline, up to 6 weeks
Title
Kids Screen-52
Description
quality of life test
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocío Martín Valero, PhD
Organizational Affiliation
Universidad de Málaga
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Teresa Labajos Manzanares, PhD
Organizational Affiliation
Universidad de Málaga
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Málaga
City
Málaga
ZIP/Postal Code
29071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
an average of 2 years

Learn more about this trial

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

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