Cerebral Palsy (CP)NCT07448207
Association Between Extremity Muscle Strength and Functional Outcomes in Children With Cerebral Palsy
An observational study of Cerebral Palsy (CP), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP)
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Jun 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, İzmir, 35410
About this study
Official 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
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.
Read the 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.
Note (October 2026): CP QOL-Child parent-proxy data were collected but could not be analysed. A total score not defined in the instrument manual had been derived, one domain had been scored in the reverse direction, and item-level responses were not retained, so scores could not be recomputed according to the manual. This outcome is therefore not reported in the primary publication.
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Muscle Strength, Participation, Quality of Life, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (single assessment session)
Secondary outcomes (4)
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) Domain Scores
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.
Measured: 1 day
Cerebral Palsy Quality of Life Questionnaire (CP QOL) Total Score
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. Note (October 2026): Not analysed; scores could not be verified against the instrument manual (see Detailed Description).
Measured: 1 day
Assessment of Life Habits (LIFE-H) Total Score
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.
Measured: 1 day
Pediatric Outcomes Data Collection Instrument (PODCI) Global Function Score
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Sep 2022
- Primary completion1 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL SOYKAN, Hacettepe University
- Investigators
- Mintaze Kerem Günel, PT, Prof. Dr., Principal investigator, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448207
- Sponsor's protocol ID
- HU-FTR-AS-01
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07448207
- Acronym / sponsor ID
- HU-FTR-AS-01
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Muscle Strength, Participation, Quality of Life, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Note (October 2026): CP QOL-Child parent-proxy data were collected but could not be analysed. A total score not defined in the instrument manual had been derived, one domain had been scored in the reverse direction, and item-level responses were not retained, so scores could not be recomputed according to the manual. This outcome is therefore not reported in the primary publication.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) Domain Scores
Time frame: 1 day
Cerebral Palsy Quality of Life Questionnaire (CP QOL) Total Score
Time frame: 1 day
Assessment of Life Habits (LIFE-H) Total Score
Time frame: 1 day
Pediatric Outcomes Data Collection Instrument (PODCI) Global Function Score
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mintaze Kerem Günel, PT, Prof. Dr. principal investigator
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy (CP), run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.