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

Cerebral Palsy Clinical Trial

Official title:

Comparison of the Tactile Functions and the Effects of Possible Tactile Deficit on Motor Function in Unilateral Cerebral Palsy and the Typically Developed Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013814
• Other study ID #: 09.2018.312
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2020
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Rehabilitation
• Tactile Perception

Intervention

Diagnostic Test:
• Semmes-Weinstein monofilament 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
• Box and Block 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
• 9-Hole Peg 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.
• Duruöz Hand Index (DHI)
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.
• Jamar hand dynamometer
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.
• Hydraulic pinch gauge
Hydraulic pinch gauge is used for evaluation of finger grip strength. The evaluation method was the same as Jamar hand dynamometer.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Mean score of gross manual dexterity assessment test according to the tactile function	Tactile function was determined by the Semmes-Weinstein monofilament score. The Box-Block Test scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.	1 day (Single time point)
Secondary	Mean score of hand grip strength test according to the tactile function	Tactile function was determined by the Semmes-Weinstein monofilament score. The Jamar dynamometer scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.	1 day (Single time point)
Secondary	Mean score of finger grip strength test according to the tactile function	Tactile function was determined by the Semmes-Weinstein monofilament score. The pinch gauge scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.	1 day (Single time point)
Secondary	Mean score of hand function test according to the tactile function	Tactile function was determined by the Semmes-Weinstein monofilament score. The Duruöz Hand Index scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.	1 day (Single time point)
Secondary	Mean score of finger dexterity assessment test according to the tactile function	Tactile function was determined by the Semmes-Weinstein monofilament score. The 9-Hole Peg Test scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.	1 day (Single time point)