Back to resultsContralateral Isokinetic Training on Strength and Reaching Skill
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physical therapy exercises
Isokinetic training
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria: hemiplegic CP children from both genders with age ranged from five to seven year had mild to moderate spasticity according to the Modified Ashworth Scale able to follow verbal instructions able to stand unassisted and ambulate with abnormal pattern Exclusion Criteria: children who had any visual or auditory problems, fixed deformities in upper limb that interfere with fine motor functions, with history of any surgical interference in upper limbs for less than one year, and un-cooperative children were excluded.
Sites / Locations
- Amira Hussin Mohammed
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group (A)
study Group (B)
Arm Description
They received a physiotherapy program
They received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second
Outcomes
Primary Outcome Measures
Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power.
Isokinetic dynamometer was used to measure the concentric isokinetic shoulder abductors peak torque in Newton- meters and average power at an angular velocity of 180 degrees per second in concentric mode with gravity adjustment
Secondary Outcome Measures
Modified functional scale for reaching
It was used to measure the ability of the child to perform the reaching skills. It was used to determine the level of performance and functional improvement in reaching skills. Each child was seated in front of a table, in a chair adjustable to his or her height. They were appropriately fitted and supported to avoid any substitution movement from the child's trunk. The target was positioned on the top of the table, beside the child. The child's elbow was passively placed at full extension and the writ in natural position. Each trail of the reaching task was begun with the child's arm straight and parallel to the patient's trunk. The child was asked to make accurate reaching to touch the target by the affected arm when the examiner gives the command.
Full Information
NCT ID
NCT05718388
First Posted
January 21, 2023
Last Updated
February 6, 2023
Sponsor
Delta University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05718388
Brief Title
Contralateral Isokinetic Training on Strength and Reaching Skill
Official Title
Effect of Contralateral Isokinetic Training on Strength and Reaching Skill in Children With Spastic Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aimed to ascertain how cross-education affected the activity of the paretic muscles in the upper limb and how that affected function in children with spastic hemiplegia and cerebral palsy. Additionally, it sought to determine how unilateral isokinetic resistance training affected children with spastic hemiplegia of the contralateral limb in terms of strength development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group (A)
Arm Type
Other
Arm Description
They received a physiotherapy program
Arm Title
study Group (B)
Arm Type
Experimental
Arm Description
They received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second
Intervention Type
Other
Intervention Name(s)
Physical therapy exercises
Intervention Description
For two consecutive months, the children in control group underwent a physiotherapy program for 60min/ three sessions each week: it was based mainly on the neurodevelopment technique, directed toward inhibiting abnormal muscle tone facilitating normal patterns of postural control and hand functions training program
Intervention Type
Other
Intervention Name(s)
Isokinetic training
Intervention Description
Children in study group received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second under full supervision on the Biodex isokinetic dynamometer three times per week for 8 weeks, making a total of 24 training sessions. Each child was trained in the seated position with the similar precaution of the testing protocol.
Primary Outcome Measure Information:
Title
Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power.
Description
Isokinetic dynamometer was used to measure the concentric isokinetic shoulder abductors peak torque in Newton- meters and average power at an angular velocity of 180 degrees per second in concentric mode with gravity adjustment
Time Frame
Change from Baseline Isokinetic dynamometer parameters at 2 months
Secondary Outcome Measure Information:
Title
Modified functional scale for reaching
Description
It was used to measure the ability of the child to perform the reaching skills. It was used to determine the level of performance and functional improvement in reaching skills. Each child was seated in front of a table, in a chair adjustable to his or her height. They were appropriately fitted and supported to avoid any substitution movement from the child's trunk. The target was positioned on the top of the table, beside the child. The child's elbow was passively placed at full extension and the writ in natural position. Each trail of the reaching task was begun with the child's arm straight and parallel to the patient's trunk. The child was asked to make accurate reaching to touch the target by the affected arm when the examiner gives the command.
Time Frame
Change from Baseline Modified functional scale for reaching at 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hemiplegic CP children from both genders with age ranged from five to seven year
had mild to moderate spasticity according to the Modified Ashworth Scale
able to follow verbal instructions
able to stand unassisted and ambulate with abnormal pattern
Exclusion Criteria:
children who had any visual or auditory problems, fixed deformities in upper limb that interfere with fine motor functions, with history of any surgical interference in upper limbs for less than one year, and un-cooperative children were excluded.
Facility Information:
Facility Name
Amira Hussin Mohammed
City
Gamasa
ZIP/Postal Code
35712
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Contralateral Isokinetic Training on Strength and Reaching Skill
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