- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448207
Association Between Extremity Muscle Strength and Functional Outcomes in Children With Cerebral Palsy
The Effect of Upper and Lower Extremity Muscle Strength on Activity Level, Participation and Quality of Life in School-Age Children With Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
Upper motor neuron lesion causing Cerebral Palsy (CP) leads to various problems including muscle tone, coactivation of agonist-antagonist muscles, coordination, balance, muscle strength, loss of selective motor control, bone deformities and muscle contractures by negatively affecting motor control and these problems have been shown to affect the level of activity and participation in social life.
Studies demonstrate that increased muscle strength, especially with muscle strengthening programmes, improves functional outcomes in children with CP. Although studies exist on causal relationships between motor affectivity, GMFCS level, muscle strength and quality of life in children with CP, studies directly examining the relationship between muscle strength and activity level, participation in social life and quality of life are limited. Determining the relationship between lower and upper extremity muscle strength and participation and quality of life in children with CP is important for rehabilitation approaches. This will help focus on strengthening specific muscle groups in rehabilitation to increase participation in social life and quality of life in children with CP.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İzmir
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Ankara, İzmir, Turkey (Türkiye), 35410
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having been diagnosed with cerebral palsy,
- Being classified as Level I-II-III on the Gross Motor Classification System,
- Being classified as Level I-II on the Communication Function Classification System (IFSS) for Individuals with Cerebral Palsy,
- Having turned 6 years old by the start of the study and not having turned 12 years old by the end of the study.
Inclusion criteria for typically developing children:
- Not having been diagnosed with any neurological disorder,
- Having turned 6 years old by the start of the study and not having turned 12 years old by the end of the study.
Exclusion Criteria:
- Have a Gross Motor Classification System Level IV-V,
- Have a Communication Function Classification System (IFSS) Level III, IV, and V for individuals with cerebral palsy,
- Having undergone Botulinum Toxin-A (BTX-A) injection in the last 6 months,
- Having undergone orthopaedic surgery in the last 6 months,
- Using medication that may affect muscle strength,
- Having cardiovascular problems.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Upper and Lower Extremity Isometric Muscle Strength Measured by Hand-Held Dynamometer (ActivForce 2, Activbody, San Diego, CA, USA).
Time Frame: 1 day (single assessment session)
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Isometric muscle strength of the following muscle groups was assessed using the "Make Test" with a portable hand-held dynamometer (ActivForce 2; Activbody, San Diego, CA, USA): Shoulder abductors, Shoulder extensors, Elbow flexors, Elbow extensors, Hip abductors, Hip extensors, Knee flexors, Knee extensors.
Muscle strength values were recorded in kilograms (kg).
Higher values indicate greater muscle strength.
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1 day (single assessment session)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) Domain Scores
Time Frame: 1 day
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The PEDI-CAT assesses functional performance in four domains: Daily Activities, Mobility, Social/Cognitive, Responsibility.
Each domain is scored on a standardized scale (norm-based score; mean 50, SD 10).
Higher scores indicate better functional performance.
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1 day
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Cerebral Palsy Quality of Life Questionnaire (CP QOL) Total Score
Time Frame: 1 day
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The CP QOL assesses quality of life across multiple domains including: Social well-being and acceptance, Feelings about functioning, Participation and physical health, Emotional well-being and self-esteem, Pain and impact of disability. Domain scores range from 0 to 100. Higher scores indicate better quality of life. |
1 day
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Assessment of Life Habits (LIFE-H) Total Score
Time Frame: 1 day
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The LIFE-H (5-13 years version) evaluates social participation across 12 domains. Items are scored from 0 to 9: 0 = Complete restriction in participation 9 = Optimal participation Higher scores indicate better participation. |
1 day
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Pediatric Outcomes Data Collection Instrument (PODCI) Global Function Score
Time Frame: 1 day
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The PODCI evaluates health-related quality of life and functional performance across five domains: Upper Extremity Function, Transfers and Basic Mobility, Physical Function and Sports, Comfort and Pain, Happiness Scores range from 0 to 100.
Higher scores indicate better function and quality of life.
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mintaze Kerem Günel, PT, Prof. Dr., Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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
- HU-FTR-AS-01
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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