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Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
kinesio taping
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Thirty children with spastic diplegia of both genders participated in this study.

    • Theywere selected from the out-patient clinic, faculty of physical therapy, Cairo University.
    • Children height not less than 1 meter to be able to see the screen of the biodex balance system.
    • Their agehad ranged from 4 to 8 years.
    • All patients have mild spasticity according to modified Aschwar scale grade 1 &1+ (Alhusaini, 2010) presented in (Appendix I).
    • All patients wereable to stand alone GMFM presented in (Appendix II).
    • They could understand and follow instructions.
    • All Children used Ankle Foot Orthosis.

Exclusion Criteria:

  • • Children with visual or auditory problems.

    • Children with positive sensitivity to kinesiotape.
    • Children with irrivisable muscle contracture at the calf muscles.

Sites / Locations

  • Cairo Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

study group

Arm Description

15 diplegic children received regular exercise program including balance exercise

15 diplegic children recieved regular exercise program plus putting kinesiotape

Outcomes

Primary Outcome Measures

effect of K-Tape on balance
effect of using K-Tape on dorsi flexors to see its effect on balance

Secondary Outcome Measures

Full Information

First Posted
January 22, 2020
Last Updated
January 26, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04243928
Brief Title
Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia
Official Title
Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia (Using Biodex Balance System)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
August 11, 2019 (Actual)
Study Completion Date
October 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
To detect the effect of kinesio -tape on balance in children with spastic diplegia.
Detailed Description
The use of Kinesio Taping might influence the cutaneous receptors of the sensory motor system, resulting in the improvement of voluntary control and coordination in a physiotherapy program for children with CP. (Yasukawa et al., 2006). The study will be conducted To investigate the effect of kinesiotape applied on dorsi fexors muscles on improving balance in spastic diplegic children .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
children rranged from 4 years uo to 10 years with Spastic diplegia
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
15 diplegic children received regular exercise program including balance exercise
Arm Title
study group
Arm Type
Experimental
Arm Description
15 diplegic children recieved regular exercise program plus putting kinesiotape
Intervention Type
Other
Intervention Name(s)
kinesio taping
Intervention Description
apply kinesio taping on dorsi flexors muscles
Primary Outcome Measure Information:
Title
effect of K-Tape on balance
Description
effect of using K-Tape on dorsi flexors to see its effect on balance
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Thirty children with spastic diplegia of both genders participated in this study. Theywere selected from the out-patient clinic, faculty of physical therapy, Cairo University. Children height not less than 1 meter to be able to see the screen of the biodex balance system. Their agehad ranged from 4 to 8 years. All patients have mild spasticity according to modified Aschwar scale grade 1 &1+ (Alhusaini, 2010) presented in (Appendix I). All patients wereable to stand alone GMFM presented in (Appendix II). They could understand and follow instructions. All Children used Ankle Foot Orthosis. Exclusion Criteria: • Children with visual or auditory problems. Children with positive sensitivity to kinesiotape. Children with irrivisable muscle contracture at the calf muscles.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Univeristy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia

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