- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013814
The Effect of Tactile Deficit on Motor Function in Unilateral Cerebral Palsy
August 18, 2021 updated by: Marmara University
Comparison of the Tactile Functions and the Effects of Possible Tactile Deficit on Motor Function in Unilateral Cerebral Palsy and the Typically Developed Children
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34899
- Marmara University Pendik Education and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with unilateral cerebral palsy
|
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 (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-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) 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.
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 is used for evaluation of finger grip strength.
The evaluation method was the same as Jamar hand dynamometer.
|
Typically developed children
|
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 (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-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) 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.
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 is used for evaluation of finger grip strength.
The evaluation method was the same as Jamar hand dynamometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with tactile dysfunction in both groups
Time Frame: 1 day (Single time point)
|
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
Time Frame: 1 day (Single time point)
|
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
Time Frame: 1 day (Single time point)
|
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
Time Frame: 1 day (Single time point)
|
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
Time Frame: 1 day (Single time point)
|
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
Time Frame: 1 day (Single time point)
|
Mean score of pinch gauge measures was used to compare finger grip strength in both groups
|
1 day (Single time point)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean score of gross manual dexterity assessment test according to the tactile function
Time Frame: 1 day (Single time point)
|
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)
|
Mean score of hand grip strength test according to the tactile function
Time Frame: 1 day (Single time point)
|
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)
|
Mean score of finger grip strength test according to the tactile function
Time Frame: 1 day (Single time point)
|
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)
|
Mean score of hand function test according to the tactile function
Time Frame: 1 day (Single time point)
|
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)
|
Mean score of finger dexterity assessment test according to the tactile function
Time Frame: 1 day (Single time point)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Evrim Karadag-Saygi, MD, Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
January 20, 2019
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
August 12, 2021
First Submitted That Met QC Criteria
August 18, 2021
First Posted (Actual)
August 19, 2021
Study Record Updates
Last Update Posted (Actual)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 18, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2018.312
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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