- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721650
Perturbation-Based Balance Training on Trunk Proprioception and Balance in Cerebral Palsy:
Effect of Perturbation-Based Balance Training on Trunk Proprioception and Balance in Hemiplegic Cerebral Palsy: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thirty-eight patients with hemiplegic cerebral palsy will participate in this study.
The patients will randomly be divided into two equal groups; the control group which received the selected physical therapy exercise program and the study group received the same exercise training program in addition to Perturbation-Based Balance Training, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, baseline digital inclinometer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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El-Sheikh Zayed City Giza 1133 Egypt
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Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt
- October 6 University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Thirty-eight children hemiplegic cerebral palsy
- Age will range as (8:10) years old
- Spastic hemiplegic cerebral palsy
- Normal body mass index ranged from 1SD to -2SDaccording to BMI-for age Z score charts include an age and sex- specific BMI for children (WHO, 2007).
- Gross motor function classification system: level I&II
Exclusion Criteria:
• Difficulty to communicate or to understand program instructions
- any other neurological deficits or orthopaedic abnormalities,
- secondary musculoskeletal complication
- vestibular problems
- any mental impairment
Study Plan
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 |
|---|---|
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Other: control group
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trunk control therapeutic exercise, static and dynamic balance treaining exercises
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Other: study group
|
Perturbation-based balance training (PBT; or reactive balance training or perturbation training) is balance training that uses repeated, externally applied mechanical perturbations to trigger rapid reactions to regain postural stability in a safe and controlled environment
trunk control therapeutic exercise, static and dynamic balance treaining exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BIODEX balance system
Time Frame: three months
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to evaluate postural balance.
The BBS is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress.
|
three months
|
|
Pediatric Balance Scale
Time Frame: three months
|
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children.
The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
|
three months
|
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baseline digital inclinometer.
Time Frame: four weeks
|
for measuring lateral movement in applications like: Earth movement in the landslide zone.
Detecting shear planes in hydraulic structures.
Measuring stability during construction
|
four weeks
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005471
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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