NCT04243928

Brief Summary

To detect the effect of kinesio -tape on balance in children with spastic diplegia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
Last Updated

January 28, 2020

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

January 22, 2020

Last Update Submit

January 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • effect of K-Tape on balance

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

    three months

Study Arms (2)

control group

ACTIVE COMPARATOR

15 diplegic children received regular exercise program including balance exercise

Other: kinesio taping

study group

EXPERIMENTAL

15 diplegic children recieved regular exercise program plus putting kinesiotape

Other: kinesio taping

Interventions

apply kinesio taping on dorsi flexors muscles

control groupstudy group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with visual or auditory problems.
  • Children with positive sensitivity to kinesiotape.
  • Children with irrivisable muscle contracture at the calf muscles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Univeristy

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • I

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: children rranged from 4 years uo to 10 years with Spastic diplegia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ROLE OF KINESIOTAPE OVER DORSI FLEXORS MUSCLES ON BALANCE IN CHILDREN WITH SPASTIC DIPLEGIA

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 28, 2020

Study Start

February 10, 2019

Primary Completion

August 11, 2019

Study Completion

October 13, 2019

Last Updated

January 28, 2020

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations