The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy

August 27, 2022 updated by: Fatih Ozden, Muğla Sıtkı Koçman University

The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy

The aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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
    • Fethiye
      • Muğla, Fethiye, Turkey, 48300
        • Fethiye Private Son Atılım Special 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 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
  • Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
  • Understanding simple commands and signing the consent form

Exclusion Criteria:

  • Presence of equinus deformity
  • Situations that may prevent assessments or communication
  • Lack of cooperation during work
  • Presence of surgery that may affect assessments, such as joint freezing
  • Presence of botulinum toxin administration in the last 6 months
  • Development of an allergic reaction on the skin to the tape

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesio Taping Group (KTG)
Distortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist.
Other: Kinesio Taping
In addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied.
Active Comparator: Conventional Rehabilitation Group (CRG)
Conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.
Other: Conventional Rehabilitation
Conventional rehabilitation practices are carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TUG
Time Frame: Change from Baseline TUG at 3 days
Patients are asked to get up from a standard chair, walk 3 meters at a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated. There is no score range in TUG.
Change from Baseline TUG at 3 days
SLS
Time Frame: Change from Baseline SLS at 3 days
The one-leg standing test measures the time one is able to stand on one lower limb without support. There is no score range in SLS.
Change from Baseline SLS at 3 days
Modified Ashworth Scale (MAS)
Time Frame: Change from Baseline MAS at 3 days
The Modified Ashworth Scale is a 6-point rating scale for gauging muscle resistance to passive movement. MAS is scored from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
Change from Baseline MAS at 3 days
WGS
Time Frame: Change from Baseline WGS at 3 days
The scale allows for a multifactorial gait analysis, takes in to account 14 observable gait parameters divided into four sub-scales referring to particular phases of gait, i.e. stance phase, toe off, swing phase, andheel strike. WGS is scored from 13.35 to 42.0. Higher scores indicate higher impairment.
Change from Baseline WGS at 3 days
CHQ
Time Frame: Change from Baseline CHQ at 3 days
The CHQ is a validated multidimensional instrument that measures the functional health and well-being of children and young people. CHQ is scored from 0 to 100. Higher scores indicate better health status.
Change from Baseline CHQ at 3 days

Collaborators and Investigators

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

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: İsmet Tümtürk, BSc, Ege University
  • Principal Investigator: Ahmet İmerci, PhD, Muğla Sıtkı Koçman 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)

March 15, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 25, 2022

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPKT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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