- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712708
Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination.
Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions.
Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship.
CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Faten Abdelaziem, PhD
- Phone Number: +20 100 855 4818
- Email: faten.hassan@pt.cu.edu.eg
Study Locations
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Giza, Egypt
- Recruiting
- Faculty of Physical therapy Cairo University
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Contact:
- Faten Abdelaziem, PhD
- Phone Number: +20 100 855 4818
- Email: faten.hassan@pt.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University.
- Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years.
- Height was above 1 meter.
- Understand verbal command.
- The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale.
Rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of Physical Therapy Cairo University.
Exclusion Criteria:
- Vertigo or dizziness.
- Epilepsy.
- Osteoporosis.
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 |
---|---|
Active Comparator: Control Group
Eighteen children with spastic CP will receive especially designed physical therapy program based on Neuro-Developmental treatment (NDT) approach with emphasis on exercise encourage independent standing, stretches exercises, strengthening exercises, approximation, enhancement and facilitation of gait patterning and ankle ROM exercises for one hour for 24 sessions
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The Mat Exercises: Stretching exercises to all spastic muscle groups (Kalkman et al., 2018). Gentle exercises was applied for 40-60 seconds and repeated from 3-5 times/ movement as supported by (Fragala et al., 2003). Strengthening Exercises: Dynamic Rising Positioning The Gym Exercises: |
Experimental: Study Group
ighteen children with spastic CP will receive the same program that the control group received in addition to especially designed exercises using rebound therapy (Mini Trampoline) that include push up exercise, standing, squatting, single limb squatting, kneeling position, catching and throwing a ball over head in kneeling position, catching and throwing a ball over head in standing position, kicking the ball, broad jumping with assistance, jumping in place, for 1 hour three times per week for three successive months.
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The Mat Exercises: Stretching exercises to all spastic muscle groups (Kalkman et al., 2018). Gentle exercises was applied for 40-60 seconds and repeated from 3-5 times/ movement as supported by (Fragala et al., 2003). Strengthening Exercises: Dynamic Rising Positioning The Gym Exercises:
Rebound therapy is the therapeutic use of full sized trampoline or mini sized trampoline.
It provides opportunities for exercise recreation and therapy; and it is distinct from gymnastic trampolining.
It is used for facilitating movements, improving balance, enhancing coordination and promoting motor performances in children with different disorders includes learning disabilities, communication disorders and motor dysfunction (Rebound Therapy South Africa, 2020; The Chartered society of Physiotherapists, 2016).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: 12 Weeks
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Stationary Balance Using Biodex Balance System
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12 Weeks
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Gross Motor Function
Time Frame: 12 Weeks
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Gross Motor Function using Gross Motor Function Measure (GMFM)
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12 Weeks
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Gross Motor Coordination
Time Frame: 12 Weeks
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Gross Motor Coordination Using Gross Motor Coordination Quotient in BOT-2
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12 Weeks
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Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T. REC/012/002421
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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