Cerebral PalsyNCT06231108
Which Taping Technique is More Effective on Balance Skills in Children With Mildly Affected Cerebral Palsy?
An observational study of Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Kinesio Taping
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2024to 1 Dec 2025
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: "Cooperative children diagnosed with mild cerebral palsy with GMFCS levels 1 and 2."
Who may be able to join
- 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.
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Abant Izzet Baysal University
Bolu
Seda AYAZ TAS, Phd, +90 549 545 80 40, seda.ayaztas@ibu.edu.tr
Ozge KARANLIK, Msc
About this study
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"
"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."
Read the 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."
- Conditions
- Cerebral Palsy
- Being tested
- Kinesio Taping
- Keywords
- Cerebral Palsy, Balance, Postural, Kinesio Tape
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
"Three different taping applications will be applied, namely ankle correction, quadriceps facilitation, and gluteus maximus facilitation."
- Taping: Functional correction technique will be used to facilitate dorsal flexion movement."
- 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.
- Taping: Gluteus Maximus (GM) Facilitation Technique - For taping to facilitate the GM muscle, a double-band application will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | "In the Single Group, three different taping applications will be performed." Receives: Other: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start21 Jan 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
- Investigators
- Ozge KARANLIK, Msc, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231108
- Sponsor's protocol ID
- BAIBU-FTR-SAT-3
- Status last verified
- Feb 2025
- First submitted
- 21 Jan 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06231108
- Acronym / sponsor ID
- BAIBU-FTR-SAT-3
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Balance, Postural, Kinesio Tape
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: Kinesio Taping"In the Single Group, three different taping applications will be performed." |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- "Cooperative children diagnosed with mild cerebral palsy with GMFCS levels 1 and 2."
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio Taping"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. | Other | Case Group |
Primary outcome
Static Balance Assessment
Time frame: day 1
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ozge KARANLIK, Msc principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seda Ayaz Taş, Phd (+90 549 545 80 40, seda.ayaztas@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance Assessment (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.