The Effect of Tactile Deficit on Motor Function in Unilateral Cerebral Palsy

NCT05013814 | Completed

• 1 other identifier: 09.2018.312
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy(CP) is the most common cause of disability in childhood. The motor spectrum of disorders is characterized by abnormal muscle tone, posture, and movement. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition and behavior. Besides classical appearance of symptomatology, tactile impairment takes an important place to be evaluated. Assessment of the integrity of tactile function composes of two main steps: tactile registration and tactile perception. Our main goal is the define the effect of tactile impairment on hand motor function with the usage of identical assessment tools in patients with unilateral cerebral palsy (UCP) and typically developed children (TDC).

Conditions

Cerebral Palsy; Rehabilitation; Tactile Perception

Outcome Measures

Primary Outcomes (6)

• Number of participants with tactile dysfunction in both groups

  Comparison of the number of patients with tactile dysfunction according to the Semmes-Weinstein monofilament test scores.

  1 day (Single time point)

• Mean score of gross manual dexterity assessment test in all participants

  Mean score of Box-Block Test was used to compare gross manual dexterity assessment in both groups

  1 day (Single time point)

• Mean score of hand grip strength test in all participants

  Mean score of Jamar dynamometer measures was used to compare hand grip strength in both groups

  1 day (Single time point)

• Mean score of hand function test in all participants

  Mean score of Duruöz Hand Index was used to compare hand function in both groups

  1 day (Single time point)

• Mean score of finger dexterity assessment test in all participants

  Mean score of 9-Hole Peg Test was used to compare finger dexterity assessment in both groups

  1 day (Single time point)

• Mean score of finger grip strength test in all participants

  Mean score of pinch gauge measures was used to compare finger grip strength in both groups

  1 day (Single time point)

Secondary Outcomes (5)

• Mean score of gross manual dexterity assessment test according to the tactile function

  1 day (Single time point)

• Mean score of hand grip strength test according to the tactile function

  1 day (Single time point)

• Mean score of finger grip strength test according to the tactile function

  1 day (Single time point)

• Mean score of hand function test according to the tactile function

  1 day (Single time point)

• Mean score of finger dexterity assessment test according to the tactile function

  1 day (Single time point)

Study Arms (2)

Children with unilateral cerebral palsy

Diagnostic Test: Semmes-Weinstein monofilament test; Diagnostic Test: Box and Block Test; Diagnostic Test: 9-Hole Peg Test; Diagnostic Test: Duruöz Hand Index (DHI); Diagnostic Test: Jamar hand dynamometer; Diagnostic Test: Hydraulic pinch gauge

Typically developed children

Diagnostic Test: Semmes-Weinstein monofilament test; Diagnostic Test: Box and Block Test; Diagnostic Test: 9-Hole Peg Test; Diagnostic Test: Duruöz Hand Index (DHI); Diagnostic Test: Jamar hand dynamometer; Diagnostic Test: Hydraulic pinch gauge

Interventions

Semmes-Weinstein monofilament test DIAGNOSTIC_TEST

Tactile function was evaluated mainly as tactile registration by using 20-item Semmes-Weinstein monofilament (SWM) kit. The monofilament was applied three times with a pseudorandom order to distal pad of the thumb, index, 4th and 5th digits (C6, C7 and C8 dermatomes). The lowest value of monofilament was recorded which the child was able to correctly identify at least one touch out of three

Children with unilateral cerebral palsy; Typically developed children

Box and Block Test DIAGNOSTIC_TEST

Box and Block Test (BBT) was used for dexterity assessment. The BBT measures unilateral gross manual dexterity. The child was asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds

Children with unilateral cerebral palsy; Typically developed children

9-Hole Peg Test DIAGNOSTIC_TEST

9-Hole Peg Test (9-HPT) is used to measure finger dexterity. Firstly, the child takes the pegs from a container, one by one, and place them in the holes on the board; then participant removes the pegs from the holes and replaces them back into the container. The total time taken to complete the test is recorded in seconds.

Children with unilateral cerebral palsy; Typically developed children

Duruöz Hand Index (DHI) DIAGNOSTIC_TEST

Duruöz Hand Index (DHI) is an 18-item self-report questionnaire regarding ability to carry out manual tasks. Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The total score ranges from 0-90 with higher scores indicating poorer hand function.

Children with unilateral cerebral palsy; Typically developed children

Jamar hand dynamometer DIAGNOSTIC_TEST

Hand grip strength was measured by using Jamar hydraulic hand dynamometer. Measurement was done with the participant in sitting position and the elbow at 90 degrees of flexion. The force has most commonly been measured in kilograms according to the amount of static force that the hand can squeeze around the dynamometer.

Children with unilateral cerebral palsy; Typically developed children

Hydraulic pinch gauge DIAGNOSTIC_TEST

Hydraulic pinch gauge is used for evaluation of finger grip strength. The evaluation method was the same as Jamar hand dynamometer.

Children with unilateral cerebral palsy; Typically developed children

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population consists of 2 groups. In the group of typically developed children, there are healthy children who do not have a disease that will affect normal development. The other group includes children diagnosed with unilateral cerebral palsy.

You may qualify if:

• Ages between 5-15 years
• Being evaluated as Class I-II-III in Gross Motor Function Classification System
• Being evaluated as Class I-II-III in Manual Ability Classification System

You may not qualify if:

• Inability to understand and/or follow test instructions due to intellectual or behavioral difficulties
• History of upper extremity botulinum toxin type A injection in the last three months,
• Previous upper extremity orthopedic surgery
• History of major trauma, and visual impairment

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Education and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Evrim Karadag-Saygi, MD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: September 1, 2017
• Primary Completion: January 20, 2019
• Study Completion: January 1, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

TU (1)