- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739396
Core Stabalization and Rebound Therapy and CP
Effect of Core Stabalization Versus Rebound Therapy on Balance in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PURPOSE:
To compare the effect of core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy
BACKGROUND:
Cerebral palsy is primarily a disorder of movement and posture
HYPOTHESES:
There is no significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy.
RESEARCH QUESTION:
Is there a significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy?
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Faculty of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children diagnosed with spastic hemiplegic CP.
- Their chronological age ranged from 5 to 8 years,
- able to follow verbal commands or instructions during testing procedures,
- degree of spasticity in affected lower limbs ranged between1 to 1+ according to Modified Ashworth scale (MAS),
- they are able to understand and follow instructions given to them,
Exclusion Criteria:
- Children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with Botulinium toxin or any orthopaedic surgery in lower limbs 6m before study,
- children who were suffering from cardiopulmonary problems or epilepsy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: rebound therapy
Rebound exercises will be applied for group B. this group will receive rebound exercise training in addition to traditional physical therapy .
Rebound exercises were conducted on a mini-trampoline and BOSU ball.
Passive bouncing will be conducted while the child was standing with his/her feet a shoulder-width apart.
The therapist will held the child's legs while applying upward and downward movement.
The bouncing started slowly.
The child then will progress to include the rebound exercises, starting with active bounce, where in a hands free manner the therapist will ask the child to speed up or slow down the bounce rate according to the child's abilities
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The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks
Other Names:
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Experimental: core stabalization
The core stability exercises will be used for core stabilization training of group (A) in addition to traditional physical therapy.
The core stability program included 3 levels.
Each exercise lasted 5 min, and the children shifted from one exercise to the next after the complete performance of the preceding exercise.
The first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10-20 repetitions), and supine twist (10-20 repetitions).
The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions).
Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3-5 s, followed by a slow relaxation phase, with 10-20 repetitions)
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The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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balance
Time Frame: 12 week
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it measures the degree of tilting for each axis during dynamic conditions and calculates a medial lateral stability index (MLSI); an anterior-posteriorstability index (APSI); and an overall stability index(OSI),
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12 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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gross motor function measure-88
Time Frame: 12 week
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measure gross motor function.
higher scores indicate better outcome.
scores are reported in percentage.
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12 week
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lafayette hand held dynamometer
Time Frame: 12 week
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measure isometric muscle strength of knee flexors and extensors.
higher scores reflect better outcome
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12 week
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6 minute walk test
Time Frame: 12 week
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measure endurance.
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12 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faculty OP Therapy, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- P.T.REC/012/003117
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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