- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07338812
Virtual Reality and Whole Body Vibration on Muscle Strength and Balance in Children With DMD
January 4, 2026 updated by: Mostafa S Ali, Cairo University
Efficacy of Virtual Reality and Whole Body Vibration on Muscle Strength and Balance in Children With Duchenne Muscular Dystrophy
we measure balance and quadriceps strength in Duchenne muscular dystrophy children after applying virtual reality and whole body vibration
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Two groups of fifty children with Duchenne muscular dystrophy, aged 6 to 10, were randomly assigned after being selected from the outpatient clinic of faculty of physical therapy, Cairo University.
Both groups (A and B) participated in physical treatment for three consecutive months; group (A) had designed physical therapy in addition to virtual reality, whereas group (B) had the same physical therapy program with whole-body vibration three times per week.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
-
Cairo, Egypt, 11432
- Cairo university
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Giza, Egypt, 11432
- Cairo university
-
-
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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- children diagnosed with DMD
- aged between 6 and 10 years
- having lower extremities and trunk muscle strength of grade 3+
- were able to move their upper and lower limbs normally and being able to walk unhindered at levels I and II of the Ambulation function classification system for DMD (AFCSD)
Exclusion Criteria:
- cardiopulmonary dysfunction or skeletal abnormalities that are either congenital or acquired
- had previously experienced lower limb surgical procedure
- had neurological conditions that affected their balance and gait or had poor motor development
- exhibited behavioural disorders preventing them from cooperating during the trial
- being overweight (body mass index (BMI) >25 kg/ m2) because a lot of fat makes it hard for the ultrasound to measure thickness
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: virtual reality
group (A) had designed physical therapy in addition to virtual reality
|
Group (A) had designed physical therapy in form of Warm up with gentle stretching movements to prevent injuries.
The lower limb muscles on both sides were stretched for 20 seconds, followed by 20 seconds of relaxation, five times.
The quadriceps, hamstrings, anterior tibial group, calf muscles, biceps, and triceps were also contracted isometrically.
Every muscle contraction was held for 5 seconds, followed by 5 seconds of relaxation, and the process was repeated five times in addition to virtual reality inform of VR program.
Nintendo Wii Fit Balance Board (Nintendo, Kyoto, Japan) was used to perform the exercises.
In each session, VR was used for a total of 10 minutes three times per week for three consecutive months.
|
|
Experimental: whole-body vibration
group (B) had the same physical therapy program with whole-body vibration
|
Group (B) had the same physical therapy program with WBV (Power Plate Pro 5) for a total of 10 minutes per session.
The apparatus was set at 30 Hz frequency, 2 mm amplitude, and 5 minutes of operating time.
The children were squatted down completely on a vibrating, side-alternating platform and were told to stay that way throughout the experience, communicating any pain they felt to the researchers.
The vibration feature automatically shuts off after 5 minutes.
After that, the children took a one-minute break.
Then, with the same settings as those used in the squatting position, children stood on the vibration platform for 5 minutes.
In each session, WBV was used for a total of 10 minutes three times per week for three consecutive months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
balance
Time Frame: 12 weeks
|
Biodex Balance System (BBS) (BSS; Biodex, Inc, Shirley, NY) was used to evaluate each child's dynamic balance.
It is a multiaxial tool that records and evaluates a person's capacity to maintain joint stability under dynamic stress.
The BBS uses a circular platform that can move concurrently in the anterior-posterior and medial-lateral axes, unlike force plate technologies.
|
12 weeks
|
|
quadriceps muscle strength
Time Frame: 12 weeks
|
The Lafayette Manual Muscle Tester (MMT) Model Number 01163 combines accuracy and precision with contemporary ergonomic design to generate exact, impartial, and reliable results.
The three replaceable, cushioned stirrups made it possible to employ established methods with assurance and effectiveness while preserving patient comfort
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 11, 2025
Primary Completion (Actual)
May 20, 2025
Study Completion (Actual)
October 12, 2025
Study Registration Dates
First Submitted
January 4, 2026
First Submitted That Met QC Criteria
January 4, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 4, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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