WBV on Fascicle Lenght and Knee Joint Angle in CP

September 17, 2024 updated by: Mostafa S Ali, Cairo University

Efficacy of Whole Body Vibration on Fascicle Length and Joint Angle in Children With Hemiplegic Cerebral Palsy

This study investigates the effects of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

to study the effect of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

Study Type

Interventional

Enrollment (Actual)

80

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

  • Egypt
    • Married
      • Giza, Married, Egypt, 12668
        • mostafa 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:

  • Ages varied from four to six years of both sex
  • hemiplegic CP children, were suffering from knee joint flexion deformity due to hamstring muscles tightness
  • Level I and II motor function, according to the Growth Motor Function Classification System (GMFC) expanded and revised
  • Degree of spasticity ranged from 1 to 2 according to modified Ashworth scale
  • All children received neuro-developmental techniques

Exclusion Criteria:

  • Other causes of knee flexion deformities
  • Previous history of orthopedic surgery in knee joint
  • Visual or auditory problems
  • Seizures
  • Sensory or perceptual deficits
  • Any acute illness at the time of collection of data.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: physical therapy group
Control group: received a designed physical therapy program
Other: designed physiotherapy program
structured therapeutic exercise program that included neurodevelopmental approaches, balance exercises, milestone facilitation, stretching exercises, and postural reaction facilitation. The program was conducted for one hour each day, three days a week.
Other Names:
  • physical therapy program
Experimental: whole body vibration group
experimental group: received a designed physical therapy program in addition to WBV for 12 weeks
Other: designed physiotherapy program
structured therapeutic exercise program that included neurodevelopmental approaches, balance exercises, milestone facilitation, stretching exercises, and postural reaction facilitation. The program was conducted for one hour each day, three days a week.
Other Names:
  • physical therapy program
Device: whole body vibration
On a vibration platform, the children went into a complete squat. The device was calibrated at a frequency of 30 Hz, an amplitude of 2 mm, and a duration of 5 minutes. After the vibration was turned on, the children were told to stay in the squatting position and to report any discomfort that could occur. The vibration automatically shut off after five minutes. The children then rested for a minute. Next, under the identical conditions as for the squatting position, they were instructed to stand on the vibration platform for five minutes with the therapist's assistance. Consequently, WBV was applied for a total of 10 minutes during each session.
Other Names:
  • WBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee range of motion
Time Frame: 12 weeks
Each child in both groups had their knee joint's extension angle measured before and after a 12-week therapy program began using an absolute + AxisTM Digital Goniometer
12 weeks
Fascicle length of hamstring muscle
Time Frame: 12 weeks
The biceps femoris muscle's muscle fascicle length was measured at a frequency of 7.5 MHz using GE LOGIQ P6 ultrasonography equipment
12 weeks
gross motor function
Time Frame: 12 weeks

Gross Motor Functional Measurement-88 : is a common principle-test designed to assess changes in function in various milestones for children with cerebral palsy 0 = does not initiate

  1. = initiates
  2. = partially completes
  3. = completes
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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)

July 22, 2023

Primary Completion (Actual)

August 2, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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