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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey, 34899
        • Marmara University Pendik Education and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Children with unilateral cerebral palsy
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
Diagnostic test: 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
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: Hydraulic pinch gauge
Hydraulic pinch gauge is used for evaluation of finger grip strength. The evaluation method was the same as Jamar hand dynamometer.
Typically developed children
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
Diagnostic test: 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
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: Hydraulic pinch gauge
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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