Clinical trial NCT06231108: Which Taping Technique is More Effective on Balance Skills in Children With Mildly Affected Cerebral Palsy?
Official title: "Assessment of the Short Effects of Taping on the Foot, Knee, and Hip Regions on Balance Skills in Children With Mildly Affected Cerebral Palsy"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Balance, Postural
Kinesio Tape
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "Cooperative children diagnosed with mild cerebral palsy with GMFCS levels 1 and 2."

Brief summary: "Our study aims to determine which of ankle correction, quadriceps facilitation, and gluteus maximus facilitation taping provides a better immediate effect on balance skills in children with mildly affected cerebral palsy. Children whose parents have given consent for the study will undergo three different taping applications with a one-week interval. After each taping application, a 15-minute waiting period will be observed, followed by balance assessment using the Wii Balance System with eyes open and closed."

Detailed description: "Our study aims to investigate which of ankle taping, quadriceps femoris facilitation taping, and gluteus maximus facilitation taping is more effective on balance skills in children with mildly affected cerebral palsy. The study will invite ambulatory children aged 4-15 receiving special education and rehabilitation support at the Turkish Spastic Children Foundation, and those who agree to participate will be included. First, the demographic data of the children will be recorded, and then they will be assessed using the Gross Motor Function Classification System, Eating and Drinking Abilities Classification System, Hand Skills Classification System, and Communication Function Classification System.

Each child will undergo three different taping applications with a one-week interval. After each taping application, a 15-minute wait period will be observed, followed by static balance measurement using the Wii Balance Board with eyes open and closed, and the results will be recorded. SPSS (Statistical Package for Social Sciences) version 20.0 will be used for the statistical analysis of the data. The Shapiro-Wilk test will be used to determine the normality of data distributions. Parametric tests will be employed for data showing normal distribution, while non-parametric tests and one-way analysis of variance (ANOVA) will be used for data not showing normal distribution. If subgroup analysis of demographic data and clinical characteristics of cases is needed, the Independent Sample T-test or Mann-Whitney U test, and Chi-square test will be used.

To determine the relationship between independent variables, either Pearson correlation test or Spearman correlation test will be selected based on the normality of data distribution. A significance level of p \< 0.05 will be considered statistically significant in all analyses. The results of the research aim to reveal which taping technique is more effective on balance skills and to promote the widespread use of the more effective technique in clinical practice."

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of bilateral spastic type cerebral palsy (CP),
* Age between 4-15 years,
* Communication Function Classification System (CFCS) level 1-2,
* Gross Motor Function Classification System (GMFCS) level 1-2,
* Volunteering to participate in the study.

Exclusion criteria:

* Having experienced lower extremity fracture, muscle-tendon, or bone surgery in the last 6 months, or undergone spine or orthopedic surgery that would affect the lower extremity,
* Exposure to any pharmacological agent or intervention inhibiting spasticity in the last 6 months,
* Developing an allergic reaction to kinesio tape."

Primary outcomes:
measure: Static Balance Assessment
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Ozge KARANLIK, Msc
role: PRINCIPAL_INVESTIGATOR
References: