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

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic
• Interventions: Other: Conventional Rehabilitation; Other: Kinesio Taping

• Registration Number: NCT05251532
• Lead Sponsor: Muğla Sıtkı Koçman University

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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-02-13
• Study First Posted: 2022-02-22
• Study Start: 2022-03-15
• Status Verified: 2022-08
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-25
• Last Update Submitted: 2022-08-27
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Rehabilitation Group (CRG)	Conventional Rehabilitation	Conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.
Kinesio Taping Group (KTG)	Kinesio Taping	Distortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist.

Primary Outcome Measures

Name	Time	Method
TUG	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.
Modified Ashworth Scale (MAS)	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.
WGS	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.
CHQ	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.
SLS	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.

Trial Locations

Locations (1)

Fethiye Private Son Atılım Special Education and Rehabilitation Center; 🇹🇷 Muğla, Fethiye, Turkey