NCT07429175

Brief Summary

Cerebral palsy (CP) is characterized by many problems related to brain damage. One of these is sensory impairment. Sensory impairments in CP patients can also occur together with motor functions. Detecting sensory impairments (two-point discrimination, vibration, joint position sense, thermal sensation, stereognosis, graphesthesia) in the arm, forearm, and hand (upper extremity) in CP patients and investigating their relationship with motor functions is important. The aim of this research is to investigate the relationship between upper extremity sensory impairments and motor functions in patients diagnosed with unilateral (affecting one half of the body) CP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

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, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 27, 2026

Last Update Submit

February 17, 2026

Conditions

Keywords

cerebral palsysensory functionmotor function

Outcome Measures

Primary Outcomes (11)

  • Sensory Function:Two-point discrimination

    Two-point discrimination is defined as the ability to distinguish between two simultaneous points of touch, which is most acute in areas of the skin with a high density of touch receptors, such as the fingers and face. The test will be performed using a discriminator device called an esthesiometer.

    Single assessment at baseline (cross-sectional evaluation)

  • Sensory Function:Joint position sense

    Joint position sense is the ability to detect body segment position in space and is commonly used to represent proprioceptive performance.

    Single assessment at baseline (cross-sectional evaluation)

  • Sensory Function:Vibration

    Assessment of vibration sense is the best clinical test of the dorsal column pathway. A low-frequency (128 Hz) tuning fork is applied to bony prominences and the patient (with closed eyes) is asked to report when the vibration starts and stops.

    Single assessment at baseline (cross-sectional evaluation)

  • Sensory Function:thermal sense

    The volunteer's upper extremity is successively touched with tubes filled with hot and cold water, and the volunteer is asked to respond as hot or cold. Thermal sensation is recorded as 'preserved', 'impaired', or 'unable to assess'.

    Single assessment at baseline (cross-sectional evaluation)

  • Sensory Function:Stereognosis

    Without visual or auditory cues, objects are placed in a sequence, and the child is asked to grasp them and identify the name of the object. Each object is awarded '1' point for being correctly identified, and '0' points for not identifying it. Scores ranging from 0 to 6 are recorded.

    Single assessment at baseline (cross-sectional evaluation)

  • Sensory Function:Graphesthesia

    Six different drawings-letters, numbers, circles, and vertical lines-are made on the palm of the volunteer's hand using a blunt pencil, without any visual or auditory stimuli. Each correct drawing earns '1' point, and each incorrect drawing earns '0' points. Scores ranging from 0 to 6 are recorded.

    Single assessment at baseline (cross-sectional evaluation)

  • Motor Function: Gross Motor Functional Classification System

    This classification system consists of 5 levels.

    Single assessment at baseline (cross-sectional evaluation)

  • Motor Function: Hand Skills Classification System

    This classification system consists of 5 levels.

    Single assessment at baseline (cross-sectional evaluation)

  • Motor Function: Abilhand-Kids Scale

    Twenty-one daily activities were evaluated. Participants were asked to rate an activity-which the child attempted to perform independently using both upper extremities-on a scale of 0-42 points.

    Single assessment at baseline (cross-sectional evaluation)

  • Motor Function: Nine Hole Peg Test

    The Nine Hole Peg Test was developed to measure finger dexterity, also known as fine manual dexterity. The test consists of a wooden board with nine holes and nine small sticks designed to be inserted into those holes. The participant is asked to take the sticks from the box one by one with the hand being tested and insert them into the holes as quickly as possible; then, they must remove the sticks one by one and return them to the box.

    Single assessment at baseline (cross-sectional evaluation)

  • Motor Function: Box and Block Test

    The Box and Block Test (BBT) measures unilateral gross manual dexterity. Participants are given 60 seconds to move wooden blocks by hand to the opposite compartment as quickly as possible. At the end of 60 seconds, the number of wooden blocks transferred to the opposite compartment is noted.

    Single assessment at baseline (cross-sectional evaluation)

Study Arms (2)

Patient Group

Children aged 6-15 with unilateral (hemiplegic) cerebral palsy

Healthy Group

Healthy children aged 6-15

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with unilateral cerebral palsy (CP) who meet the inclusion criteria and who apply to the Physical Medicine and Rehabilitation Department Clinic or Outpatient Clinic of Ankara University Faculty of Medicine, as well as healthy volunteers, will be included in the study.

You may qualify if:

  • Children aged 15 with unilateral cerebral palsy (CP)
  • Being between Gross Motor Functional Classification System I-IV
  • Not having undergone surgery or botulinum toxin application to the affected upper extremity in the last 6 months
  • Understanding what is said and being able to follow commands
  • The patient or their relatives having completed an informed consent form

You may not qualify if:

  • Having a neurological disease affecting the motor and sensory system other than cerebral palsy
  • The participant having a dermatological, vascular, or orthopedic problem in the upper extremity that would prevent assessment
  • Having uncorrected vision and hearing problems
  • Having autism spectrum disorder and attention deficit hyperactivity disorder
  • Having insufficient intelligence level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Birkan Sonel Tur, Professor

    Ankara University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 24, 2026

Study Start

September 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations