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Completed

NCT Number: NCT05251532

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

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.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fethiye Private Son Atılım Special Education and Rehabilitation Center

Muğla, Fethiye, 48300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesio Taping

Other

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

conventional rehabilitation

Other

Conventional rehabilitation practices are carried out

Primary outcomes

  1. TUG

    Time frame: 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.

  2. SLS

    Time frame: 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.

  3. Modified Ashworth Scale (MAS)

    Time frame: 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.

  4. WGS

    Time frame: 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.

  5. CHQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2022
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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