Back to resultsThe Efficacy of Derotation 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
About this trial
This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Kinesio taping, Cerebral palsy
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 a static cause of femoral internal rotation 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
Conventional rehabilitation application will be performed in addition to Kinesio Tex tape derotation taping.
A conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.
Outcomes
Primary Outcome Measures
6MWT
The 6-meter course was mapped as 10 meters in length with a 2-meter acceleration interval and a 6-meter testing interval. There is no scoring range for the 6MWT.
PBBT
PBBT is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks. PBBT is scored between 0 to 56. Higher scores indicate better function.
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.
EVGS
EVGS was developed to evaluate gait in children with CP using video recordings. It includes 17 variables, and each of these variables can be scored as 0, 1, or 2 based on movement deviation from normal. enced measure and examines functional balance in the context of everyday tasks. EVGS is scored between 0 to 34. Higher scores indicate worse gait function.
KINDL
The KINDL was derived from a conceptual model, in which the four main components of quality of life, namely psychological well-being, social relationships, physical function and everyday life activities, were included in interviews with children. KINDL is scored between 0 to 100. Higher scores indicate better quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT05251519
First Posted
January 31, 2022
Last Updated
August 27, 2022
Sponsor
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT05251519
Brief Title
The Efficacy of Derotation Banding on Outcome Measures in Children With Cerebral Palsy
Official Title
The Efficacy of Derotation Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Femoral Internal Rotation 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 26, 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 derotation taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with femoral internal rotation deformity.
Detailed Description
Conventional rehabilitation (CR) practices will be applied to the control group. Conventional rehabilitation (KT) application will be applied to the study group in addition to Kinesio Tex tape derotation banding. With the kinesio tape application, it is aimed to provide economical, ergonomic and effective support to the patients in non-clinical times. 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
Kinesio taping, Cerebral palsy
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
Conventional rehabilitation application will be performed in addition to Kinesio Tex tape derotation taping.
Arm Title
Conventional Rehabilitation Group (CRG)
Arm Type
Active Comparator
Arm Description
A conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Intervention Description
Derotation taping with Kinesio Tex is applied to the patients through a pediatric physiotherapist.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
Conventional rehabilitation program is applied to the patients through a pediatric physiotherapist
Primary Outcome Measure Information:
Title
6MWT
Description
The 6-meter course was mapped as 10 meters in length with a 2-meter acceleration interval and a 6-meter testing interval. There is no scoring range for the 6MWT.
Time Frame
Change from Baseline 6MWT at 3 days
Title
PBBT
Description
PBBT is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks. PBBT is scored between 0 to 56. Higher scores indicate better function.
Time Frame
Change from Baseline PBBT at 3 days
Title
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
EVGS
Description
EVGS was developed to evaluate gait in children with CP using video recordings. It includes 17 variables, and each of these variables can be scored as 0, 1, or 2 based on movement deviation from normal. enced measure and examines functional balance in the context of everyday tasks. EVGS is scored between 0 to 34. Higher scores indicate worse gait function.
Time Frame
Change from Baseline EVGS at 3 days
Title
KINDL
Description
The KINDL was derived from a conceptual model, in which the four main components of quality of life, namely psychological well-being, social relationships, physical function and everyday life activities, were included in interviews with children. KINDL is scored between 0 to 100. Higher scores indicate better quality of life.
Time Frame
Change from Baseline KINDL 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 a static cause of femoral internal rotation 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 Derotation Banding on Outcome Measures in Children With Cerebral Palsy
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