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

The Efficacy of Derotation Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Femoral Internal Rotation Deformity in Children With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Kinesio Taping; Other: Conventional Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fethiye
    • Muğla, Fethiye, Turkey, 48300
      • Fethiye Private Son Atılım Special Education and Rehabilitation Center

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio Taping Group (KTG); Conventional rehabilitation application will be performed in addition to Kinesio Tex tape derotation taping.	Other: Kinesio Taping; Derotation taping with Kinesio Tex is applied to the patients through a pediatric physiotherapist.
Active Comparator: Conventional Rehabilitation Group (CRG); A conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.	Other: Conventional Rehabilitation; Conventional rehabilitation program is applied to the patients through a pediatric physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline 6MWT at 3 days
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.	Change from Baseline PBBT at 3 days
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.	Change from Baseline MAS at 3 days
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.	Change from Baseline EVGS at 3 days
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.	Change from Baseline KINDL at 3 days

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 26, 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): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 27, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cerebral palsy; Kinesio taping
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: CPKT1

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