- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347483
Assessment of Trunk Position Sense, Trunk Control, and Functional Independence in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional and descriptive study was conducted in children with unilateral and bilateral spastic cerebral palsy aged between 6 and 12 years. A total of 78 children (36 girls and 42 boys) with spastic cerebral palsy were included in the study. The gross motor function levels of the participants ranged from Level I to Level IV according to the Gross Motor Function Classification System (GMFCS).
Participants were recruited from children receiving education and rehabilitation services at special education and rehabilitation centers in Kayseri, Turkiye, and only children whose parents or legal guardians provided written informed consent were included.
Demographic and clinical characteristics of the participants were recorded using a structured sociodemographic data form.
Trunk position sense was assessed using a dual inclinometer device to evaluate trunk proprioception. Trunk control was evaluated using the Trunk Impairment Scale, and functional independence was assessed using the motor subscale of the Pediatric Functional Independence Measure (WeeFIM). In addition, muscle tone was assessed bilaterally using the Modified Ashworth Scale.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Have a diagnosis of unilateral or bilateral spastic cerebral palsy,
- Are aged between 6 and 12 years,
- Are able to sit independently,
- Have a cognitive level sufficient to understand and follow verbal instructions,
- Have not undergone surgical intervention or Botulinum Toxin A injection within the last 6 months,
- Have parents or legal guardians who have provided written informed consent.
Exclusion Criteria:
- Have received Botulinum Toxin or intrathecal baclofen treatment within the last 6 months,
- Have a history of pelvic, spinal, or upper extremity surgery,
- Have severe visual or hearing impairments,
- Have cognitive impairments preventing effective communication,
- Are unable to sit independently,
- Do not have parental consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Spastic Cerebral Palsy
|
This study does not contain any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Position Sense
Time Frame: Data collection was conducted between January 2022 and March 2023.
|
Trunk proprioception assessed using a dual inclinometer device during trunk flexion movements with the repositioning angle method under eyes-open and eyes-closed conditions.
|
Data collection was conducted between January 2022 and March 2023.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Control
Time Frame: January 2022 - March 2023
|
Assessed using the Trunk Impairment Scale (TIS) in sitting position.
|
January 2022 - March 2023
|
|
Functional Independence
Time Frame: January 2022 - March 2023
|
Assessed using the motor subscale of the Pediatric Functional Independence Measure (WeeFIM).
|
January 2022 - March 2023
|
|
Muscle Tone
Time Frame: January 2022 - March 2023
|
Assessed bilaterally using the Modified Ashworth Scale (MAS).
|
January 2022 - March 2023
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Selvin Balki, Assoc. prof. Dr, Cumhuriyet University
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCU-FTR-SB-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
Clinical Trials on Only measurements were taken.
-
Puer Research, LLCEnrolling by invitation
-
Jichao QinRecruiting
-
Gang WangEnrolling by invitation
-
University of ZagrebCompletedDry Eye SyndromesCroatia
-
Osijek University HospitalJosip Juraj Strossmayer University of OsijekCompletedStomach Neoplasms | Surgical Procedures, Operative | Colorectal Neoplasms Malignant | Pancreatic Cancer, Adult
-
Guangdong Provincial People's HospitalCompletedBlood Pressure | Congenital Heart Disease in Children | Coarctation of Aorta | Interrupted Aortic Arch | Hypoplasia of Aorta
-
Meir Medical CenterUnknown
-
Second Affiliated Hospital, School of Medicine,...RecruitingLocked-In Syndrome;Pulmonary Arteriovenous MalformationChina
-
Izmir Bakircay UniversityEge UniversityCompletedBlood Glucose, LowTurkey
-
Ziv Medical CenterCompletedLimb Length Discrepancy | Total Hip