Duchenne Muscular Dystrophy (DMD)NCT07338812
Virtual Reality and Whole Body Vibration on Muscle Strength and Balance in Children With DMD
A study testing virtual reality and whole body vibration in people with Duchenne Muscular Dystrophy (DMD), run by Cairo University at 2 sites in Egypt.
Trial summary
we measure balance and quadriceps strength in Duchenne muscular dystrophy children after applying virtual reality and whole body vibration Read more about this study
- Who is it for?
- Ages 6 to 10 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- virtual reality and whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Apr 2025to 12 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- virtual reality, whole body vibration
- Keywords
- Virtual reality, whole-body vibration, muscle strength, balance, children, Duchenne muscular dystrophy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
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.
whole body vibrationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | group (A) had designed physical therapy in addition to virtual reality Receives: Device: virtual reality |
| whole-body vibration | Experimental | group (B) had the same physical therapy program with whole-body vibration Receives: Device: whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
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.
Measured: 12 weeks
quadriceps muscle strength
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start11 Apr 2025
- Primary completion20 May 2025
- Study completion12 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338812
- Sponsor's protocol ID
- P.T.REC/012/006030
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality and Whole Body Vibration on Muscle Strength and Balance in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT07338812
- Acronym / sponsor ID
- P.T.REC/012/006030
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- Virtual reality, whole-body vibration, muscle strength, balance, children, Duchenne muscular dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 12 Oct 2025 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
we measure balance and quadriceps strength in Duchenne muscular dystrophy children after applying virtual reality and whole body vibration
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Device: virtual realitygroup (A) had designed physical therapy in addition to virtual reality |
| whole-body vibration | Experimental | Device: whole body vibrationgroup (B) had the same physical therapy program with whole-body vibration |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityGroup (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. | Device | virtual reality |
| whole body vibrationGroup (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. | Device | whole-body vibration |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and whole body vibration in people with Duchenne Muscular Dystrophy (DMD), run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.