- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473311
Whole Body Vibration and Virtual Reailtry on Quadriceps Strength and Activity of Daily Living in Children With Burn
June 22, 2024 updated by: Mostafa S Ali, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
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
-
-
Married
-
Giza, Married, Egypt, 12668
- Mostafa S Ali
-
-
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:
- 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
Exclusion Criteria:
- 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.
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: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: virtual reality
|
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).
|
|
Experimental: whole body vibration
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quadriceps strength
Time Frame: 2 months
|
measurement of quadriceps power by Baseline Economy Mechanical Push/Pull
|
2 months
|
|
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
|
2 MONTHS
|
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)
May 10, 2024
Primary Completion (Actual)
June 17, 2024
Study Completion (Actual)
June 17, 2024
Study Registration Dates
First Submitted
June 13, 2024
First Submitted That Met QC Criteria
June 22, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 22, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/ 005015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
2 MONTHS
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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