- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506527
Assessment of Respiratory Function Cerebral Palsy Using Plyometric Exercise Sensorimotor Program
Assessment of Respiratory Function in Children With Cerebral Palsy Using Combined Plyometric Exercise and Sensorimotor Program: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is a varied group of developmental disorders secondary to a static immature brain injury that primarily results in persistent nonspecific impairment of movement and posture. Approximately 25% of all CP cases experience disturbance of motor function with unilateral spasticity pertaining to the upper and lower extremities contralateral to the affected cerebral hemisphere and categorized as spastic hemiplegia. Some asymmetries might be noted when hemiplegic children are attempting to perform motor activities. In supported standing, hemiplegic children may stand preferentially on their more functional side and exhibit postural malalignments that impair the ability to transfer body weight on the affected lower extremity.
Children and adolescents with CP have poor respiratory function, secondary to the disease process. Impaired airway clearance, recurrent aspirations, chest infections, poor cough mechanism, impaired lung function, deformity of the spine and chest, and poor nutrition status influence the respiratory condition of children and adults with CP resulting in reduced lung capacity in these individuals.
Plyometric exercises are a specific pattern of resistive strength training in which the muscle starts to contract eccentrically followed by rapid concentric contraction of the same muscle. It can jointly generate high velocity dynamic movements and high-impact force on the muscles and bones. Currently, a limited number of studies have analysed the efficacy of the plyometric training on respiratory function in children with CP or any other disabling health conditions. Preliminary studies have demonstrated the positive effect of plyometric exercises for the gross motor function in boys with unilateral CP.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed Abo-El-Ros, Ph.D
- Phone Number: +201206530584
- Email: maboelroose@ecu.edu.eg
Study Contact Backup
- Name: Marian Fayez, Ph.D
- Phone Number: +201222748287
- Email: mfayez@ecu.edu.eg
Study Locations
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-
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Giza, Egypt, 12613
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age will be 8 - 14 years.
- children will be assigned to the study are suffering from spastic hemiplegic cerebral palsy (less than grade 1+ om Modified Ashwar Scale)
- Considering the physical problems, children will be chosen according to Growth Motor Function Classification System (GMFCS) with levels I-III
- The ability to understand simple verbal instructions.
Exclusion Criteria:
- Visual and hearing impairment; surgery within the last three months preventing them from taking part in sensorimotor physical therapy
- Severe oromotor issues
- Severe chest infections
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: study group 1
Study group A: will receive combined plyometric exercises and sensorimotor program
|
Children in study group A will receive combined plyometric exercises (vertical paradigm) and sensorimotor program - Children of the study group B will receive sensorimotor program alone. |
|
Experimental: study group 2
Study group B: will receive sensorimotor program alone
|
Children in study group A will receive combined plyometric exercises (vertical paradigm) and sensorimotor program - Children of the study group B will receive sensorimotor program alone. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of spasticity
Time Frame: six weeks
|
will be measured by modified Ashower Scale
|
six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of Respiratory capacity and vital capacity
Time Frame: six weeks
|
will be measured by incentive spirometry
|
six weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eman Abdel-Halim, Cairo University
Study record dates
Study Major Dates
Study Start (Anticipated)
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/012/003787
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
product manufactured in and exported from the U.S.
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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