Whole Body VibrationNCT06473311
Whole Body Vibration and Virtual Reailtry on Quadriceps Strength and Activity of Daily Living in Children With Burn
A study testing whole bady vibration and virtual reality in people with Whole Body Vibration and Virtual Reality, run by Cairo University at 1 site in Egypt.
Trial summary
Burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. Mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Whole Body Vibration, Virtual Reality
- What is being tested?
- whole bady vibration and virtual reality
- 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
- 10 May 2024to 17 Jun 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both sexes were included
- Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns
- Their ages ranged from 6 to 12 years, d) They can assume standing position
Who cannot join
- 1st, 3rd and 4th degrees of burn
- Other types of burn rather than thermal
- Neurological or neuromuscular disorders
- Dermatological disorders
- Visual or hearing disorder
- Child with contractures or lower limbs on fixed deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Proprioceptive Stimulations on Quadriceps Strength and Activity of Daily Living in Children With Burn
Burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. Mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. The immobility of the patient has a major impact on their physical health. The aim of current study was to compare between the effect of virtual reality and whole body vibration as two methods of proprioceptive stimulation on quadriceps strength and activity of daily living in children with burn.
Read the detailed description
The current study is pre-post experimental study which was carried out from January 2024 to June 2024. A stratified and convenience sampling technique was used to select the study participants taking into consideration the inclusion criteria. Forty children with lower limb thermal burn were selected from Ahlah Misr Burn Hospital to participate in this study. They were selected according to the following inclusion criteria: a) Both sexes were included, b) Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns, c) Their ages ranged from 6 to 12 years, d) They can assume standing position. A child who had one or more of the following criteria was excluded from the study: a) 1st, 3rd and 4th degrees of burn, b) Other types of burn rather than thermal, c) Neurological or neuromuscular disorders, d) Dermatological disorders, e) Visual or hearing disorder, f) Child with contractures or lower limbs on fixed deformities. Subjects who met the previous mentioned criteria were randomly assigned into two study groups of equal numbers Study I \& study II using sealed envelope. Study group I were treated by a conventional physical therapy program directed towards improving the condition of the patient function in addition to whole body vibration therapy. Study group II were treated by a Wii-fit therapy program in a form of virtual reality treatment program in addition to the same conventional physical therapy program given to patients in the study group I.
- Conditions
- Whole Body Vibration, Virtual Reality
- Being tested
- whole bady vibration and virtual reality
- Keywords
- Burn, proprioceptive stimulation, Whole body vibration, Virtual reality, Activity of daily living
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole bady vibration and virtual realityDevice
study group I received a whole body vibration program in addition to a conventional physical therapy program, and study group II received a Wii-fit therapy program (a virtual reality treatment program) in addition to the same. A two-month treatment program was implemented for both groups. Every child in both groups had the same evaluation processes, which included using the Physical Self Maintenance Scale (PSMS) for daily living activities and a dynamometer to measure quadriceps muscular strength. Evaluation was done prior to the start of treatment and was done again after one month (post I) and two months (post II).
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration | Experimental | Not described Receives: Device: whole bady vibration and virtual reality |
| virtual reality | Experimental | Not described Receives: Device: whole bady vibration and virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
quadriceps strength
measurement of quadriceps power by Baseline Economy Mechanical Push/Pull
Measured: 2 months
activities of daily living
measurement od ADL by Physical Self Maintenance Scale. the score is 1 and zero the better score is 1
Measured: 2 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start10 May 2024
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whole Body VibrationStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473311
- Sponsor's protocol ID
- P.T.REC/012/ 005015
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ali MS. Whole Body Vibration or Virtual Reality on Muscle Strength and Activity of Daily Living in Children With Burn: A Comparative Trial. Physiother Res Int. 2025 Oct;30(4):e70102. doi: 10.1002/pri.70102.
PubMed 40886124
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Proprioceptive Stimulations on Quadriceps Strength and Activity of Daily Living in Children With Burn
- ClinicalTrials.gov ID
- NCT06473311
- Acronym / sponsor ID
- P.T.REC/012/ 005015
- Conditions
- Whole Body Vibration, Virtual Reality
- Keywords
- Burn, proprioceptive stimulation, Whole body vibration, Virtual reality, Activity of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 25 Jun 2024 (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.
Burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. Mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. The immobility of the patient has a major impact on their physical health. The aim of current study was to compare between the effect of virtual reality and whole body vibration as two methods of proprioceptive stimulation on quadriceps strength and activity of daily living in children with burn.
Detailed description
The current study is pre-post experimental study which was carried out from January 2024 to June 2024. A stratified and convenience sampling technique was used to select the study participants taking into consideration the inclusion criteria. Forty children with lower limb thermal burn were selected from Ahlah Misr Burn Hospital to participate in this study. They were selected according to the following inclusion criteria: a) Both sexes were included, b) Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns, c) Their ages ranged from 6 to 12 years, d) They can assume standing position. A child who had one or more of the following criteria was excluded from the study: a) 1st, 3rd and 4th degrees of burn, b) Other types of burn rather than thermal, c) Neurological or neuromuscular disorders, d) Dermatological disorders, e) Visual or hearing disorder, f) Child with contractures or lower limbs on fixed deformities. Subjects who met the previous mentioned criteria were randomly assigned into two study groups of equal numbers Study I \& study II using sealed envelope. Study group I were treated by a conventional physical therapy program directed towards improving the condition of the patient function in addition to whole body vibration therapy. Study group II were treated by a Wii-fit therapy program in a form of virtual reality treatment program in addition to the same conventional physical therapy program given to patients in the study group I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole body vibration | Experimental | Device: whole bady vibration and virtual reality |
| virtual reality | Experimental | Device: whole bady vibration and virtual reality |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both sexes were included
- Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns
- Their ages ranged from 6 to 12 years, d) They can assume standing position
Key exclusion criteria (6 listed)
- 1st, 3rd and 4th degrees of burn
- Other types of burn rather than thermal
- Neurological or neuromuscular disorders
- Dermatological disorders
- Visual or hearing disorder
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 |
|---|---|---|
| whole bady vibration and virtual realitystudy group I received a whole body vibration program in addition to a conventional physical therapy program, and study group II received a Wii-fit therapy program (a virtual reality treatment program) in addition to the same. A two-month treatment program was implemented for both groups. Every child in both groups had the same evaluation processes, which included using the Physical Self Maintenance Scale (PSMS) for daily living activities and a dynamometer to measure quadriceps muscular strength. Evaluation was done prior to the start of treatment and was done again after one month (post I) and two months (post II). | Device | virtual reality, whole body vibration |
Primary outcome
quadriceps strength
Time frame: 2 months
measurement of quadriceps power by Baseline Economy Mechanical Push/Pull
activities of daily living
Time frame: 2 MONTHS
measurement od ADL by Physical Self Maintenance Scale. the score is 1 and zero the better score is 1
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 25 Jun 2024.
- Derived from this study: PubMed 40886124Ali MS. Whole Body Vibration or Virtual Reality on Muscle Strength and Activity of Daily Living in Children With Burn: A Comparative Trial. Physiother Res Int. 2025 Oct;30(4):e70102. doi: 10.1002/pri.70102.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole bady vibration and virtual reality in people with Whole Body Vibration and Virtual Reality, 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 3 inclusion and 6 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 25 Jun 2024. 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?
quadriceps strength (time frame: 2 months). 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?
On the ClinicalTrials.gov record for NCT06473311, which also lists 1 linked publication.
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 25 Jun 2024.