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Completed

NCT Number: NCT07448207

Association Between Extremity Muscle Strength and Functional Outcomes in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, İzmir, 35410, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) Domain Scores

    Time frame: 1 day

    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.

  2. Cerebral Palsy Quality of Life Questionnaire (CP QOL) Total Score

    Time frame: 1 day

    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.

  3. Assessment of Life Habits (LIFE-H) Total Score

    Time frame: 1 day

    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.

  4. Pediatric Outcomes Data Collection Instrument (PODCI) Global Function Score

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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