- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04246645
Effect of Core Stability Exercises on Hand Functions in Children With Hemiparesis
Study Overview
Detailed Description
Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.
Objective: The purpose was to investigate the effectivness of core stability exercises on hand functions in hemiplegic cerebral palsy.
Methods: Thirty hemiparetic cerebral palsied children of both sexes, ranged in age from 6 to 8 years enrolled in this study. They randomly assigned into two groups of equal number. Group (A) received the selective physiotherapy exercises and group (B) received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks. Time motor performance, gross manual dexterity and skills of the upper extremity were assessed by using Jebsen Taylor Test (JTHFT), Box and Block Test (BBT) and Quality Upper Extremity Skill Test (QUEST) respectively before and after treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Badr Univesity in Cairo (BUC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The level of gross motor function ranged from II to III, according to Gross Motor Function Classification System
- All participants are cognitively capable and competent of interpreting and following instructions
Exclusion Criteria:
- if they had fixed contractures or deformities of the spine, upper or lower extremities,
- visual or respiratory disorders, orthopedic surgery on their involved upper extremity;
- dorsal rhizotomy;
- botulinum toxin therapy in the upper extremity musculature during the past 6 months
- who wished to receive it within the period of study
Study Plan
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 |
|---|---|
|
NO_INTERVENTION: CONTROL GROUP
received the selective physiotherapy exercises
|
|
|
EXPERIMENTAL: STUDY GROUP
received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks
|
SELECTED CORE EXERCISES
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebsen Taylor Test
Time Frame: Jebsen Taylor Test used to assess gross manual dexterity before the intervention and after three months of the intervention . the loweest score indicate improvement
|
scale used to asses gross manual dexterity
|
Jebsen Taylor Test used to assess gross manual dexterity before the intervention and after three months of the intervention . the loweest score indicate improvement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test
Time Frame: Box and Block Test used to asses gross manual dexterity pre and after 3 months of intervension
|
scale used to asses gross manual dexterity
|
Box and Block Test used to asses gross manual dexterity pre and after 3 months of intervension
|
|
Quality Upper Extremity Skill Test
Time Frame: Quality Upper Extremity Skill Test scale used to asses skills of the upper extremity pre and after 3 months of intervension
|
scale used to asses skills of the upper extremity
|
Quality Upper Extremity Skill Test scale used to asses skills of the upper extremity pre and after 3 months of intervension
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
- Hana 2
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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