Back to resultsThe Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Pes Planus
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
exercise and taping
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Kinesio tape, Pes Planus, Q angle, Exercise
Eligibility Criteria
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
Sites / Locations
- Üsküdar UnıversıtyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
control group
experimental group
placebo group
Arm Description
In the control group, only the exercise program was applied and the first and last measurements will be compared.
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.
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.
Outcomes
Primary Outcome Measures
Calcaneo-tibial angle measurement
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.
Navicular bone drop test
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06004271
Brief Title
The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy
Official Title
The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of our study is to examine the effect of using kinesiology tape and using it for 8 weeks on Q angle and pes planus on children with cerebral palsy.
Detailed Description
At the beginning of the study, the pes planus level of the children will be determined. Then randomization will be made and divided into 3 groups with equal number of participants. The groups will be called control, experiment, and placebo. Only physiotherapy will be applied to the control group, kinesio taping and physiotherapy to the experimental group, and damask taping and physiotherapy to the placebo group. The study will be followed for 8 weeks, and pre- and post-intervention data were statistically analyzed and compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Pes Planus
Keywords
Cerebral palsy, Kinesio tape, Pes Planus, Q angle, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be made and divided into 3 groups with equal number of participants. The groups will be called control, experiment, and placebo. Only physiotherapy will be applied to the control group, kinesio taping and physiotherapy to the experimental group, and damask taping and physiotherapy to the placebo group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
In the control group, only the exercise program was applied and the first and last measurements will be compared.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Exercise protocol:
Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching
Intervention Type
Other
Intervention Name(s)
exercise and taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calcaneo-tibial angle measurement
Description
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.
Time Frame
10 weeks
Title
Navicular bone drop test
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burhan SANCAKDAR
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Üsküdar Unıversıty
City
Üsküdar
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
17355470
Citation
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.
Results Reference
background
PubMed Identifier
24377066
Citation
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.
Results Reference
background
PubMed Identifier
16603886
Citation
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.
Results Reference
background
PubMed Identifier
23500167
Citation
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.
Results Reference
background
PubMed Identifier
34407619
Citation
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.
Results Reference
background
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The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy
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