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

NCT05251519 | Completed

• 1 other identifier: CPKT1
• 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 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.

Conditions

Cerebral Palsy, Spastic

Keywords

Kinesio taping; Cerebral palsy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Kinesio Taping Group (KTG)

EXPERIMENTAL

Conventional rehabilitation application will be performed in addition to Kinesio Tex tape derotation taping.

Other: Kinesio Taping

Conventional Rehabilitation Group (CRG)

ACTIVE COMPARATOR

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

Other: Conventional Rehabilitation

Interventions

Kinesio Taping OTHER

Derotation taping with Kinesio Tex is applied to the patients through a pediatric physiotherapist.

Kinesio Taping Group (KTG)

Conventional Rehabilitation OTHER

Conventional rehabilitation program is applied to the patients through a pediatric physiotherapist

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 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

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 26, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)