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Clinical Trials/NCT07448207
NCT07448207
Completed
Not Applicable

The Effect of Upper and Lower Extremity Muscle Strength on Activity Level, Participation and Quality of Life in School-Age Children With Cerebral Palsy

Hacettepe University1 site in 1 country140 target enrollmentStarted: September 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
140
Locations
1
Primary Endpoint
Upper and Lower Extremity Isometric Muscle Strength Measured by Hand-Held Dynamometer (ActivForce 2, Activbody, San Diego, CA, USA).

Overview

Brief Summary

The aim of this study was to evaluate whether upper and lower extremity muscle strength is a factor in activity, participation and quality of life parameters in school-age children with CP and to reveal the difference in upper and lower extremity muscle strength compared to typically developing peers.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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)

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.

Secondary Outcomes

  • Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) Domain Scores(1 day)
  • Cerebral Palsy Quality of Life Questionnaire (CP QOL) Total Score(1 day)
  • Assessment of Life Habits (LIFE-H) Total Score(1 day)
  • Pediatric Outcomes Data Collection Instrument (PODCI) Global Function Score(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ANIL SOYKAN

Principal Investigator

Hacettepe University

Study Sites (1)

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