- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06004271
The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İstanbul
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Üsküdar, İstanbul, Turkey
- Üsküdar Unıversıty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed with cerebral palsy
- Gross Motor Function Classification System level 1,2 and 3
- 2-18 years
Exclusion Criteria:
- Having Gross Motor Function Classification System levels 4 and 5
- Those with genetic and metabolic diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
In the control group, only the exercise program was applied and the first and last measurements will be compared.
|
Exercise protocol: Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching |
|
Experimental: experimental group
In the experimental group, kinesiology taping will be applied twice a week for 8 weeks together with exercise.
Kinesiology taping was first applied by closing the malleoli from the upper part of the foot, and stretching it to the anterior capsule of the foot using the ligament technique.
For the second tape, it covered the plantar area under the malleolus and was attached in the form of stirrups.
During the application, the tape will be applied with full tension on the malleolus and 50-75% tension will be applied on the other parts.
|
Exercise protocol: Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching
When applying kinesiology taping to the gluteus medius, first of all, for its anterior fiber, the tape portion will be attached lateral to the Spina iliaca anterior superior by giving a slight slope downwards from the crista iliaca with 50-75% tension.
For the posterior fiber; Starting from the trochanter major, 50-75% tension will be applied along the muscle fiber.
|
|
Placebo Comparator: placebo group
Tape application will be applied in the placebo group as it was in the experimental group.
Kinesiology taping will be attached horizontally without tension along the Tensor Facie Late line.
The application to the ankle will be attached horizontally without tension slightly above the lateral malleolus.
|
Exercise protocol: Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching
In the placebo tape application, the kinesiological tappings will be adhered horizontally without tension along the long line of the Tensor facie late muscle.
The application to the ankle will be attached horizontally, without tension, slightly above the lateral malleolus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calcaneo-tibial angle measurement
Time Frame: 10 weeks
|
The calcaneo-tibial angle measurement is a method used in the general evaluation of the foot.
By measuring this angle, it is checked whether the problems in the foot are related to the rear foot.
Normal values in this measurement are eversion angles between 4° and 8°.
During the evaluation, the angle between the axis passing through the middle of the calcaneus and the place where the Achilles tendon attaches to the calcaneus will be measured, while the patient is in the prone position, not putting weight on his foot.
Measurements will be made again while standing on the ground.
Each measurement will be repeated 3 times.
The differences between the results obtained during standing and prone lying will be calculated.
The measurements will be averaged and recorded.
|
10 weeks
|
|
Navicular bone drop test
Time Frame: 10 weeks
|
This assessment method evaluates midfoot mobility and medial longitudinal arch depression.
In this method, the measurements should be between 5-9 mm.
Before the evaluation, the height of the tubercle of the navicular bone will be measured in meters in millimeters, while the patient is in a sitting position, not putting weight on his feet.
Then, the patient will be lifted up, and the patient will be asked to give equal weight to both feet in an upright position, and the measurement will be repeated 3 times.
The average of the measurements will be recorded after they are taken.
After the measurement, the difference between standing and in bed will be found.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Burhan SANCAKDAR, Uskudar University
Publications and helpful links
General Publications
- Shultz SJ, Nguyen AD, Windley TC, Kulas AS, Botic TL, Beynnon BD. Intratester and intertester reliability of clinical measures of lower extremity anatomic characteristics: implications for multicenter studies. Clin J Sport Med. 2006 Mar;16(2):155-61. doi: 10.1097/00042752-200603000-00012.
- Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
- Armstrong RW. Definition and classification of cerebral palsy. Dev Med Child Neurol. 2007 Mar;49(3):166. doi: 10.1111/j.1469-8749.2007.00166.x. No abstract available.
- Shakeri H, Keshavarz R, Arab AM, Ebrahimi I. Clinical effectiveness of kinesiological taping on pain and pain-free shoulder range of motion in patients with shoulder impingement syndrome: a randomized, double blinded, placebo-controlled trial. Int J Sports Phys Ther. 2013 Dec;8(6):800-10.
- Park EY, Kim WH. Structural equation modeling of motor impairment, gross motor function, and the functional outcome in children with cerebral palsy. Res Dev Disabil. 2013 May;34(5):1731-9. doi: 10.1016/j.ridd.2013.02.003. Epub 2013 Mar 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Lower Extremity Deformities, Congenital
- Talipes
- Cerebral Palsy
- Paralysis
- Flatfoot
Other Study ID Numbers
- Uskudar68
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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