NCT07448207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Muscle StrengthParticipationQuality of LifeCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Upper and Lower Extremity Isometric Muscle Strength Measured by Hand-Held Dynamometer (ActivForce 2, Activbody, San Diego, CA, USA).

    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.

    1 day (single assessment session)

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with cerebral palsy who applied to the Paediatric Physiotherapy and Cerebral Palsy Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Physical Therapy and Rehabilitation, Hacettepe University, and children of the same age group with typical development were included in the study.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, İzmir, 35410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mintaze Kerem Günel, PT, Prof. Dr.

    Hacettepe University, Faculty of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

September 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 15, 2023

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations