- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05718388
Contralateral Isokinetic Training on Strength and Reaching Skill
February 6, 2023 updated by: Amira Hussin Hussin Mohammed, Delta University for Science and Technology
Effect of Contralateral Isokinetic Training on Strength and Reaching Skill in Children With Spastic Hemiplegic Cerebral Palsy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gamasa, Egypt, 35712
- Amira Hussin Mohammed
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 7 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control group (A)
They received a physiotherapy program
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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
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EXPERIMENTAL: study Group (B)
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power.
Time Frame: Change from Baseline Isokinetic dynamometer parameters at 2 months
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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
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Change from Baseline Isokinetic dynamometer parameters at 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified functional scale for reaching
Time Frame: Change from Baseline Modified functional scale for reaching at 2 months
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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.
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Change from Baseline Modified functional scale for reaching at 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2022
Primary Completion (ACTUAL)
January 20, 2023
Study Completion (ACTUAL)
January 20, 2023
Study Registration Dates
First Submitted
January 21, 2023
First Submitted That Met QC Criteria
February 6, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- contralateral isokinetic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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