NCT06231108

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."

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

January 21, 2024

Last Update Submit

February 5, 2025

Conditions

Keywords

Cerebral PalsyBalance, PosturalKinesio Tape

Outcome Measures

Primary Outcomes (1)

  • Static Balance Assessment

    Wii Balance Board, which has become an alternative for balance measurement due to its portability and low cost compared to specialized laboratory environments and complex devices. The Wii Balance Board transmits the vertical ground reaction forces generated at the four corners when an individual is on the device to the Wii system via Bluetooth.To assess static balance in the participating children, the Fizyosoft Balance System developed by engineers and physiotherapists will be used.Children will be instructed to place their feet parallel to each other on the device and remain motionless for up to 15 seconds with eyes open and closed during the measurement. The coordinate values of the individuals' body weight center will be recorded in centimeters, while the performance value will be stored in the system as a percentage.

    day 1

Study Arms (1)

Case Group

"In the Single Group, three different taping applications will be performed."

Other: Kinesio Taping

Interventions

"Three different taping applications will be applied, namely ankle correction, quadriceps facilitation, and gluteus maximus facilitation." 1. Taping: Functional correction technique will be used to facilitate dorsal flexion movement." 2. Taping: Quadriceps Femoris (QF) Facilitation Technique - In taping to activate the QF muscle and regulate muscle tone, the patient will be placed in a supine position with hips and knees in neutral. 3. Taping: Gluteus Maximus (GM) Facilitation Technique - For taping to facilitate the GM muscle, a double-band application will be performed.

Case Group

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

"Cooperative children diagnosed with mild cerebral palsy with GMFCS levels 1 and 2."

You may qualify if:

  • 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.

You may not qualify if:

  • 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."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ozge KARANLIK, Msc

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2024

First Posted

January 30, 2024

Study Start

January 21, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations