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

NCT03879304 | Completed DMC

• 1 other identifier: UMalagaRV
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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]

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, up to six weeks

Secondary Outcomes (4)

• EPInfant

  through study completion, average 6 weeks

• NSAA o North Star Ambulatory Assessment

  Baseline, up to 6 weeks

• MFM o Motor Function Measure

  Baseline, up to 6 weeks

• Kids Screen-52

  Baseline.

Study Arms (2)

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.

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.

Other: traditional physiotherapy program

Interventions

multimodal physiotherapy program with RV OTHER

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

Multimodal physiotherapy program with RV

traditional physiotherapy program OTHER

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

Traditional physiotherapy program

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• An other Dystrophies.
• Older than 10 years.
• Not Physiotherapy. Not walk.
• Asociated heart disease Sprains, fractures. FC \>120, Sat O2 \<89%.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Universidad de Málaga

Málaga, 29071, Spain

Location

Related Publications (2)

• 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.

  PMID: 33289679 BACKGROUND

• 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.

  PMID: 37990809 RESULT

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rocío Martín Valero, PhD

  Universidad de Málaga

  STUDY DIRECTOR

• Maria Teresa Labajos Manzanares, PhD

  Universidad de Málaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 18, 2019
• Study Start: March 15, 2021
• Primary Completion: October 30, 2022
• Study Completion: March 11, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)