Assessment of Respiratory Function Cerebral Palsy Using Plyometric Exercise Sensorimotor Program
Primary Purpose
Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sensorimotor program and plyometric exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring respiratory capacity, cerebral palsy, plyometric exercise
Eligibility Criteria
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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group 1
study group 2
Arm Description
Study group A: will receive combined plyometric exercises and sensorimotor program
Study group B: will receive sensorimotor program alone
Outcomes
Primary Outcome Measures
change of spasticity
will be measured by modified Ashower Scale
Secondary Outcome Measures
change of Respiratory capacity and vital capacity
will be measured by incentive spirometry
Full Information
NCT ID
NCT05506527
First Posted
August 15, 2022
Last Updated
August 17, 2022
Sponsor
Egyptian Chinese University
1. Study Identification
Unique Protocol Identification Number
NCT05506527
Brief Title
Assessment of Respiratory Function Cerebral Palsy Using Plyometric Exercise Sensorimotor Program
Official Title
Assessment of Respiratory Function in Children With Cerebral Palsy Using Combined Plyometric Exercise and Sensorimotor Program: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egyptian Chinese University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To examine if adding plyometric exercises to sensorimotor exercises would improve respiratory function in children and adolescents with cerebral palsy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
respiratory capacity, cerebral palsy, plyometric exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
Participant
Masking Description
lottery method
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group 1
Arm Type
Experimental
Arm Description
Study group A: will receive combined plyometric exercises and sensorimotor program
Arm Title
study group 2
Arm Type
Experimental
Arm Description
Study group B: will receive sensorimotor program alone
Intervention Type
Other
Intervention Name(s)
Sensorimotor program and plyometric exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of spasticity
Description
will be measured by modified Ashower Scale
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
change of Respiratory capacity and vital capacity
Description
will be measured by incentive spirometry
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abo-El-Ros, Ph.D
Phone
+201206530584
Email
maboelroose@ecu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Fayez, Ph.D
Phone
+201222748287
Email
mfayez@ecu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Abdel-Halim
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Respiratory Function Cerebral Palsy Using Plyometric Exercise Sensorimotor Program
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