NCT06004271

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 9, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

Cerebral palsyKinesio tapePes PlanusQ angleExercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    10 weeks

  • 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.

    10 weeks

Study Arms (3)

control group

ACTIVE COMPARATOR

In the control group, only the exercise program was applied and the first and last measurements will be compared.

Other: exercise

experimental group

EXPERIMENTAL

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.

Other: exerciseOther: exercise and taping

placebo group

PLACEBO COMPARATOR

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.

Other: exerciseOther: placebo

Interventions

Exercise protocol: Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching

control groupexperimental groupplacebo group

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.

experimental group
placeboOTHER

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.

placebo group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being diagnosed with cerebral palsy
  • Gross Motor Function Classification System level 1,2 and 3
  • years

You may not qualify if:

  • Having Gross Motor Function Classification System levels 4 and 5
  • Those with genetic and metabolic diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Üsküdar, Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 17355470BACKGROUND
  • 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.

    PMID: 24377066BACKGROUND
  • 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.

    PMID: 16603886BACKGROUND
  • 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.

    PMID: 23500167BACKGROUND
  • 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.

    PMID: 34407619BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyFlatfootMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Burhan SANCAKDAR

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 12, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations