Down SyndromeNCT07816120
Comparative Study of Two Applications on Muscle Strength, Balance and Motor Function in Children With Down Syndrome.
A study testing virtual reality and whole body vibration in people with Down Syndrome and Vibration Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
To differentiate between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Down Syndrome, Vibration Therapy, Virtual Reality
- 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
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2026to 12 Jul 2026
- 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
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of children ranged from 6 to 10 years old.
- Children who are able to stand independently.
- Their heights around one meter or more to meet the assessment criteria of the Biodex balance system.
- They are able to follow the verbal commands or instructions.
Who cannot join
- Children with deafness and auditory perceptual disorders.
- Spinal deformities and foot deformities that interfere with balance.
- Epilepsy or seizures.
- History of surgical interference in lower limbs.
- Botulinum toxin injections of the lower limb prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
To differentiate between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome.
Read the detailed description
Is there difference between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome?
- Conditions
- Down Syndrome, Vibration Therapy, Virtual Reality
- Being tested
- virtual reality, whole body vibration
- Keywords
- down syndrome, children, motor function, balance, muscle strength
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
Participants in Group A underwent therapy using the Wii-Fit program, engaging in 30-minute sessions, three times weekly, for three consecutive months. The Nintendo Wii Fit setup comprises a balance board integrated with a force plate and four pressure sensors, which evaluate the center of pressure (COP) and the distribution of load across the board. The intervention included three sequential exercise sets.
whole body vibrationDevice
participated in whole-body vibration (WBV) exercises using the KY-3001 fitness machine. Sessions were conducted three times per week over a period of three months, with each session lasting 30 minutes. Each session began with a 5-10-minute warm-up, which included three minutes of walking followed by stretches targeting the hamstrings, quadriceps, and calves
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | participants will receive Wii-Fit program Receives: Device: virtual reality |
| whole body vibration group | Experimental | participants will receive 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.
Muscle strength
Muscle strength will be assessed by Hand Held Dynamometer
Measured: 3 months
balance
Balance will be assessed by Biodex Balance System
Measured: 3 months
motor function
motor function will be assessed by Gross Motor Function Measure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start22 Feb 2026
- Primary completion10 May 2026
- Study completion12 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
- Investigators
- Mostafa S. Ali, Phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816120
- Sponsor's protocol ID
- P.T.REC/012/006638
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Applications on Muscle Strength, Balance and Motor Function in Children With Down Syndrome.
- ClinicalTrials.gov ID
- NCT07816120
- Acronym / sponsor ID
- P.T.REC/012/006638
- Conditions
- Down Syndrome, Vibration Therapy, Virtual Reality
- Keywords
- down syndrome, children, motor function, balance, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Feb 2026 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 11 Sep 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.
To differentiate between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome.
Detailed description
Is there difference between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Device: virtual realityparticipants will receive Wii-Fit program |
| whole body vibration group | Experimental | Device: whole body vibrationparticipants will receive whole body vibration |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The age of children ranged from 6 to 10 years old.
- Children who are able to stand independently.
- Their heights around one meter or more to meet the assessment criteria of the Biodex balance system.
- They are able to follow the verbal commands or instructions.
Key exclusion criteria (5 listed)
- Children with deafness and auditory perceptual disorders.
- Spinal deformities and foot deformities that interfere with balance.
- Epilepsy or seizures.
- History of surgical interference in lower limbs.
- Botulinum toxin injections of the lower limb prior to the study.
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 realityParticipants in Group A underwent therapy using the Wii-Fit program, engaging in 30-minute sessions, three times weekly, for three consecutive months. The Nintendo Wii Fit setup comprises a balance board integrated with a force plate and four pressure sensors, which evaluate the center of pressure (COP) and the distribution of load across the board. The intervention included three sequential exercise sets. | Device | virtual reality group |
| whole body vibrationparticipated in whole-body vibration (WBV) exercises using the KY-3001 fitness machine. Sessions were conducted three times per week over a period of three months, with each session lasting 30 minutes. Each session began with a 5-10-minute warm-up, which included three minutes of walking followed by stretches targeting the hamstrings, quadriceps, and calves | Device | whole body vibration group |
Primary outcome
Muscle strength
Time frame: 3 months
Muscle strength will be assessed by Hand Held Dynamometer
balance
Time frame: 3 months
Balance will be assessed by Biodex Balance System
motor function
Time frame: 3 months
motor function will be assessed by Gross Motor Function Measure
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 11 Sep 2026.
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Down Syndrome
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.
Mostafa S. Ali, Phd principal investigator
Cairo University
1 site 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 Down Syndrome and Vibration Therapy, run by Cairo University at 1 site 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Muscle strength (time frame: 3 months). The study lists 3 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 11 Sep 2026.