- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351292
Ultrasound or Whole Body Vibration on Knee Motion and Function in CP
Comparative Study of Therapeutic Ultrasound and Whole-body Vibration as Adjuncts to Passive Stretching on Knee Joint Range of Motion and Functional Ability in Children With Hemiplegic Cerebral Palsy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11432
- Cairo university
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age from 4-6 years
- knee flexion deformity due to hamstring tightness
- Gross Motor Function Classification System (GMFCS) levels I or II
- spasticity grade of 1 or 2 on the modified Ashworth Scale
Exclusion Criteria:
- other causes of knee flexion deformity
- previous orthopedic knee surgery
- significant visual, auditory, or perceptual deficits
- uncontrolled seizures; or acute illness
Study Plan
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: ultrasound group
received therapeutic ultrasound prior to stretching
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Received continuous ultrasound (1 MHz, 1.0 W/cm², 5 min per hamstring) using a Chattanooga Intelect Mobile 2 unit with a medium-sized transducer head and coupling gel
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Experimental: whole body vibration group
performed exercises on a vibrating platform before stretching
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Performed exercises on a Power Plate Pro 5 vibration platform.
Parameters were set to a frequency of 20 Hz and a fixed amplitude of 2 mm (peak-to-peak displacement).
The child maintained a semi-squat posture (approximately 30 knee flexion) for two 5-minute bouts separated by a 1-minute rest.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Knee Extension Range of Motion (ROM)
Time Frame: 12 weeks
|
Measured using an Absolute + Axis™ Digital Goniometer.
With the child supine and pelvis stabilized, the goniometer axis was aligned with the lateral femoral condyle.
The stationary arm was aligned with the greater trochanter, and the moving arm with the lateral malleolus.
The child was instructed to actively extend the knee as far as possible, and the angle was recorded.
Three measurements were taken, and the average was used for analysis
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12 weeks
|
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2. Gross Motor Function
Time Frame: 12 weeks
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Assessed using the Gross Motor Function Measure-88 (GMFM-88), a validated observational tool for children with CP. A blinded assessor, not involved in the intervention, scored the children's performance. The Gross Motor Functional Measurement-88 used to measure function. The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mostafa S ali, PhD, associate professor for pediatrics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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