- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819205
Is Kinesio Taping Treatment Effective in Children With Cerebral Palsy?
Investıgatıng the Effect of Kinesiotaping on Hand Functions in Children With Cerebral Palsy
Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children with CP may present with a variety of motor impairments.
The impaired upper limb function of children with cerebral palsy (CP) limits and restricts participation in activities of daily living.
Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic and rigid. In fact, there has been a few studies that investigates the effect of upper extremity elastic kinesiotaping. High methodological studies about its efficacy in this population are rare.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zeynep Tokel
- Phone Number: +905068535386
- Email: zeyneptkl343@gmail.com
Study Locations
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-
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İ̇zmi̇r, Turkey, 35340
- Recruiting
- Dokuz Eylul University
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Contact:
- Zeynep Tokel, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 6-18
- Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current imaginig findings
- Patient with stable clinical status
- Stage ≤2 patients depended on the modified ascwort scale
- Patients who are eligible to participate the study tests with suitable cognitive state
- Patients who agreed to participate the study.
Exclusion Criteria:
- Stage >2 patients depended on the modified ascwort scale
- Botilinum toxin intervention to the upper extremity in the last 6 months.
- Patients who undergo upper extremity surgery.
- Patients who have contraindication for kinesiotaping (Wide and severe skin injury, open wounds at risk of infection , allergic reactions)
- Patients with intense sensory and motor loss in the banding area
- Patients classified in stage IIB and above according to Zancolli stage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: kinesiotaping group(before/after)
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The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary.
The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day.
In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Box and block test
Time Frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.
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1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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Nine hole peg test
Time Frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch.
Insersion and extraction time of pegs in second are noted.
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1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified house clasification score
Time Frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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The score obtained from the Modified House Classification is calculated by recording the patient's capabilities among the listed 32 activities
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1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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Active/passive wrist dorsiflexion range of motion
Time Frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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With goniometer active/passive wrist dorsiflexion range of motion will be measured.
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1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeynep Tokel, MD, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DorkuzEUZTOKEL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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