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

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Taping
Conventional Rehabilitation
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral palsy, Kinesio taping

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fethiye Private Son Atılım Special Education and Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio Taping Group (KTG)

Conventional Rehabilitation Group (CRG)

Arm Description

Distortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist.

Conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.

Outcomes

Primary Outcome Measures

TUG
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.
SLS
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.
Modified Ashworth Scale (MAS)
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.
WGS
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.
CHQ
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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2022
Last Updated
August 27, 2022
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05251532
Brief Title
The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy
Official Title
The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral palsy, Kinesio taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Taping Group (KTG)
Arm Type
Experimental
Arm Description
Distortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist.
Arm Title
Conventional Rehabilitation Group (CRG)
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Intervention Description
In addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
Conventional rehabilitation practices are carried out
Primary Outcome Measure Information:
Title
TUG
Description
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.
Time Frame
Change from Baseline TUG at 3 days
Title
SLS
Description
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.
Time Frame
Change from Baseline SLS at 3 days
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
Change from Baseline MAS at 3 days
Title
WGS
Description
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.
Time Frame
Change from Baseline WGS at 3 days
Title
CHQ
Description
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.
Time Frame
Change from Baseline CHQ at 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, BSc
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fethiye Private Son Atılım Special Education and Rehabilitation Center
City
Muğla
State/Province
Fethiye
ZIP/Postal Code
48300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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