- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05614167
Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy
Study Overview
Detailed Description
Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder
The development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 002
- Badr University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Their age between 6 and 12 years old.
- Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
- They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997).
- They were able to understand and follow verbal instructions.
Exclusion Criteria:
- Children with any visual or auditory problems.
- Children with any surgical interference in the lower limb.
- Children with any structural deformities in joints and bones of lower limbs.
- Children with any special medications affecting muscle functions (anti-spastic drugs).
- Children who suffer from other diseases or associated disorders that interfered with physical activity.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross motor function measure
Time Frame: 3 months
|
standing and walking domain
|
3 months
|
|
Isometric muscle strength
Time Frame: 3 months
|
a handheld dynamometer
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Omnya samy, PHD, Lecturer
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Omnya3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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