Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy

October 29, 2018 updated by: Dilara Merve Sarı

Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions

The purpose of the study was to investigate the effectiveness of Cogniboard® Light Trainer, an education device with visual feedback that is added to the Neurodevelopmental Therapy Method (NDT) based upper extremity rehabilitation in children with cerebral palsy, on upper extremity functions such as joint range of motion (ROM), muscle tone, grip strength, pinch strength and functional abilities.

Study Overview

Status

Completed

Conditions

Detailed Description

Children with the diagnosis of Cerebral Palsy, aged between 4 and 18 years were included in the study, who were volunteered to participate. The participants were randomly assigned into two groups; A total of 16 sessions of rehabilitation program were applied for 2 days a week for 8 weeks. The treatment programs applied are; Group I: NDT based upper extremity rehabilitation, Group II: NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training. In the cases, pre- and post-treatment spasticity was defined with 'Modified Ashworth Scale'; upper extremity joint range of motion (ROM) with 'goniometer'; grip and pinch strength with 'dynamometer'; hand skills with 'Minnesota Hand Skill Test'; functional abilities with 'Childhood Health Assessment Questionnaire (CHAQ) and functional level with 'Gross Motor Function Classification System (GMFCS)'.

Study Type

Observational

Enrollment (Actual)

38

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
    • Eyup
      • Istanbul, Eyup, Turkey, 34050
        • Dilbade Education and Rehabilitation Center

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

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants of the study were selected among the children who applied to Dilbade Education and Rehabilitation Center for rehabilitation.

Simple random sampling method was applied to group selection.

Description

Inclusion Criteria:

  • Having the diagnosis of Cerebral Palsy (CP),
  • Aged between 4-18,
  • Having 1+ upper extremity spasticity at max according to the Modified Ashworth Scale (MAS),
  • To be able to cooperate with exercises

Exclusion Criteria:

  • Having mental retardation report,
  • Having congenital deformities,
  • Epilepsy history,
  • Having cardiac, orthopedic, visual and hearing problems,
  • Application of Botulinum Toxin (BOTOX) to the upper extremity in past six month.

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

Cohorts and Interventions

Group / Cohort
Group I
Group I: The control group. Participants in this group received only NDT based upper extremity rehabilitation. Number of the participants were 19.
Group II
Group II: The study group. Participants in this group received NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training. Number of the participants were 19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (ROM)
Time Frame: Eight weeks
Upper extremity ROM measured with universal goniometer.
Eight weeks
Spasticity
Time Frame: Eight weeks
Spasticity defined with Modified Ashworth Scale (MAS). The MAS measures resistance during passive soft-tissue stretching. Scoring: 0= normal tone. 1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension. 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM. 2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3= considerable increase in muscle tone, passive movement difficult. 4= affected part(s) rigid in flexion or extension.
Eight weeks
Grip and pinch strength
Time Frame: Eight weeks
Grip and pinch strength measured with dynamometer.
Eight weeks
Hand Skills
Time Frame: Eight weeks
Hand skills was assessed with Minnesota Dexterity Test (MMDT). MMDT is a standardized test for the evaluation of a subject's ability to move small objects various distances. The score on the test is the total seconds required to complete chosen number of test trials.
Eight weeks
Functional Abilities
Time Frame: Eight weeks
Functional abilities was assessed with Childhood Health Assessment Questionnaire (CHAQ). CHAQ is used to assess health status in children. It assesses functional ability in 8 domains of physical function (30 items) for children. Each item is scored on a four point scale ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), 3 (unable to do). The mean score of the eight domains finally makes up the disability index and ranges from 0 (no disability) to 3 (disabled).
Eight weeks
Functional Level
Time Frame: Eight weeks
Functional level was defined with Gross Motor Function Classification System (GMFCS). GMFCS looks at movements such as sitting, walking and use of mobility devices. It provides a clear description of a child's current gross motor function. Level I can climb stairs without the use of a railing. Level II can walk in most settings and climb stairs holding onto a railing. Level III needs usage of a hand held mobility device, may climb stairs holding onto a railing with assistance. Level IV requires physical assistance or powered mobility in most settings. Level V children are transported in a manuel wheelchair in all settings, they are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements.
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dilara Merve Sarı

Investigators

  • Study Director: Tugba Kuru Colak, Marmara University Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 8, 2018

Primary Completion (Actual)

May 21, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

October 27, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DilbadeEdRehabCtr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.

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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