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

Cerebral Palsy, Spastic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251519
• Other study ID #: CPKT1
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 26, 2022

Study information

• Verified date: August 2022
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 26, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

Other:
• Kinesio Taping
Derotation taping with Kinesio Tex is applied to the patients through a pediatric physiotherapist.
• Conventional Rehabilitation
Conventional rehabilitation program is applied to the patients through a pediatric physiotherapist

Locations

Country	Name	City	State
Turkey	Fethiye Private Son Atilim Special Education and Rehabilitation Center	Mugla	Fethiye

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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