Assessment of Trunk Position Sense, Trunk Control, and Fu... | NCT07347483

Studies
Assessment of Trunk Position Sense, Trunk Control, and Functional Independence in Children With Cerebral Palsy

NCT07347483

Sponsor

Cumhuriyet University

Status

Completed

Last Update Posted

Jan 16, 2026Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

Only measurements were taken.

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jan 9, 2026

First Submission Date that Met QC Criteria

Jan 9, 2026

First Posted Date

Jan 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether there is a difference in trunk proprioception, as assessed by trunk position sense, in children with unilateral and bilateral spastic cerebral palsy, and to evaluate the relationship between trunk position sense, trunk control, and functional independence.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spastic Cerebral Palsy			Other: Only measurements were taken.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Only measurements were taken.	Other	This study does not contain any intervention.	Spastic Cerebral Palsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trunk Position Sense	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 Outcomes

Measure	Description	Time Frame
Trunk Control	Assessed using the Trunk Impairment Scale (TIS) in sitting position.	January 2022 - March 2023
Functional Independence	Assessed using the motor subscale of the Pediatric Functional Independence Measure (WeeFIM).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Spastic cerebral palsy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Selvin Balki, Assoc. prof. Dr	Cumhuriyet University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sivas Cumhuriyet University		Sivas		58140	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided