NCT05213715

Brief Summary

Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder characterized by posture and movement disorders as a result of damage to the immature brain for any reason before, during or after birth.In addition to tone, postural and neuromuscular control in children with Cerebral Palsy; Problems are also observed in communication skills, perceptual and cognitive systems and sensory systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 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

January 10, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

January 15, 2022

Last Update Submit

March 30, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • upper extremity proprioseption test

    Measurements will be done by a goniometer for bilateral upper extremity shoulder flexion-abduction, elbow flexion-extension, supination-pronation, hand-wrist flexion. The eyes will be closed or the head turned to the opposite direction of the evaluated area. The difference between the value for the full range and the value for the half range will be recorded on the test paper as angular. Higher angular difference indicates worse proprioception.

    first day of assessment

  • Kinesthesia Test

    The difference in the distance between the point where the child ends the movement and the end point of the real line is measured on the evaluation paper with a ruler. The total value of the right and left obtained is recorded by subtracting from 50. The higher the difference, the better the kinesthesia. The test will be applied bilaterally.

    first day of assessment

  • somatosensory perception of upper extremity (touch stimulus localization test)

    Touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. The hand, wrist and forearm are touched once with a pencil in order, first in the pronation position and then in the supination position, and the child is asked to point to the touched area with his finger. The distance between the place touched by the pen and the place indicated by the child is measured with a ruler and recorded on the evaluation sheet in cm. The test is applied bilaterally. Evaluation; The farther the distance between the real touched place and the child touches, the worse tactile perception is interpreted, the closer the real touched place and the child's touched place, the better it is interpreted to show tactile perception.

    first day of assesment

  • somatosensory perception of upper extremity (double-touch stimulus localization test)

    Double-touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. With 2 separate pens, you can simultaneously use two different points such as left hand-right cheek, right hand-left hand, left cheek-right cheek, left hand-left cheek, right hand-left cheek, right hand-right cheek while eyes are closed. tactile. The child is asked to say or show both points touched. If the child knows both points, 2 points, 1 point if he knows one, 0 points if he does not know, and a total score is obtained. In scoring, where the best value is measured out of 14, the lower this value is interpreted as the worse tactile perception, the closer it is to this value, the better tactile perception is interpreted.

    first day of assesment

  • somatosensory perception of upper extremity (finger recognition test)

    Finger recognition test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. He is asked to put his hands on the table and the child's eyes are closed and 16 different points (8 right hand-8 left hand) are touched with a pencil. They are asked to point to the touched points with their fingers or to express audibly. For each point touched, scoring is done as 1 for a correct answer and 0 for an incorrect answer. The test was performed bilaterally. The patient's total score is obtained by summing the scores for both hands. In this measurement method, which is evaluated out of 16; The closer the value to 16 indicates good tactile perception, while the farther away it is, the worse it indicates tactile perception.

    first day of assesment

  • somatosensory perception of upper extremity (right-left discrimination test)

    Right-left discrimination test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. The child is asked to repeat the same by giving 10 body imitation commands. With the paper with the test questions in the hands of the physiotherapist, the assessment of the child begins. The score for the test is 2 points if he answers correctly in the first three seconds, 1 point if he answers in ten seconds, and 0 points if he fails to answer. The total score is recorded by summing all the sub-scores of the child from the 10 questions in the test.

    first day of assesment

  • The Jebsen Taylor Hand Function Test (JTHFT)

    The Jebsen Taylor Hand Function Test (JTHFT) will be used to assess upper extremity functional skills. JTEFT, which is used in the 6-18 age range, consists of serial subtests representing hand function in daily life. The application of this test, which consists of 6 items, takes 15-45 minutes. A scaled board is used to provide a standard arrangement of objects in the test. The time when all activities are done is recorded with a stopwatch. Higher duration indicates worse hand function.

    first day of assesment

Secondary Outcomes (3)

  • manuel ability classification system (MACS)

    first day of assessment

  • Gross Motor Function Classification System(GMFCS)

    first day of assessment

  • demographic information

    first day of assessment

Study Arms (3)

1/Children with diparetic cerebral palsy

1/Children with diparetic cerebral palsy

Other: assessment

2/Children with hemiparetic cerebral palsy

2/Children with hemiparetic cerebral palsy

Other: assessment

3/healty peer aged children

3/healty peer aged children

Other: assessment

Interventions

assessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity

1/Children with diparetic cerebral palsy2/Children with hemiparetic cerebral palsy3/healty peer aged children

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with cerebral palsy and healty peer aged children

You may qualify if:

  • Diagnosed with Hemiparetic and Diparetic CP with Gross Motor Function Classification System (GMFCS) Level ≤ 3
  • Children with ≤ 2 upper extremity muscles according to the Modified Ashworth Scale (MAS)
  • Children with Manual Skills Classification System (MACS) ≤ 3
  • Not being diagnosed with mental disability by the RAM (Guidance Research Center)
  • Children with CP aged 6-18 years
  • Not receiving surgery or Botox (Botulinum Toxin) treatment in the last 6 months
  • Children with CP with parental approval

You may not qualify if:

  • Joint contracture in the shoulder, elbow and hand-wrist
  • Having any hearing or vision problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Adıgüzel

Kahramanmaraş, Dulkadiroglu, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsySomatosensory Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • hatice adıgüzel, PhD

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffessor

Study Record Dates

First Submitted

January 15, 2022

First Posted

January 28, 2022

Study Start

January 10, 2022

Primary Completion

February 20, 2022

Study Completion

February 28, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations