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

Cerebral Palsy, Spastic Clinical Trial

Official title:

The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251532
• Other study ID #: CPKT2
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 25, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 25, 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 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

Other:
• Kinesio Taping
In addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied.
• Conventional Rehabilitation
Conventional rehabilitation practices are carried out

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	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
Primary	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
Primary	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
Primary	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
Primary	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