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

NCT05251532 | Completed

• 1 other identifier: CPKT2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy; Kinesio taping

Outcome Measures

Primary Outcomes (5)

• 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.

  Change from Baseline TUG at 3 days

• 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.

  Change from Baseline SLS at 3 days

• 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.

  Change from Baseline MAS at 3 days

• 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.

  Change from Baseline WGS at 3 days

• 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.

  Change from Baseline CHQ at 3 days

Study Arms (2)

Kinesio Taping Group (KTG)

EXPERIMENTAL

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

Other: Kinesio Taping

Conventional Rehabilitation Group (CRG)

ACTIVE COMPARATOR

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

Other: Conventional Rehabilitation

Interventions

Kinesio Taping OTHER

In addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied.

Kinesio Taping Group (KTG)

Conventional Rehabilitation OTHER

Conventional rehabilitation practices are carried out

Conventional Rehabilitation Group (CRG)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Fethiye Private Son Atılım Special Education and Rehabilitation Center

Muğla, Fethiye, 48300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ahmet İmerci, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• İsmet Tümtürk, BSc

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 22, 2022
• Study Start: March 15, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 25, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)