Protocol summary

Summary
In this quasi-experimental study we plan to compare In-toeing gait pattern before and after intervention.we Selected 15 children with spastic diplegia cerebral palsy who can walk independently and their age are between 6-10 years. In this research, our treatment is kinesiotape and we use 3-Dimentional motion analysis system for assessment. Each sample evaluate in 2 sessions (before and immediately after applying of KT). The variables in this study are: joint kinematics (sagittal, transverse and frontal planes), speed and stride length. Kinesiotape is used in spiral shape that start at the lateral maleolous and fix it at iliac crest of opposite site.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020428447N2
Registration date: 2017-02-27, 1395/12/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-27, 1395/12/09
Registrant information
Name
Amin Kordi Yoosefinejad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 1081
Email address
yoosefinejad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Immediate Effect of Spiral Kinesiotaping on In-toeing Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
Public title
The Immediate Effect of Spiral Kinesiotaping on In-toeing Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bilateral spastic cerebral palsy; Intoeing gait Pattern; 6-10years; With level 1 or 2 of GMFCS; Can follow verbal command. Exclusion criteria: Having Orthopedic surgery or injections of botulinum toxin in the past 6 months;Lack of parental consent; Allergy to kinesiotape; Failure to follow verbal commands; Standing or walking with difficulty and problems without shoe or orthosis; Blindness and deafness; History of fracture in lower limb; Infections and any other conditions that affect the anatomical structures; Subluxation or dislocation of each of the lower limb joints.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Shiraz University of Medical Science
Street address
Zand Ave., Central Building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.SUMS.REC.1395.170

Health conditions studied

1

Description of health condition studied
spastic cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Congenital spastic paralysis (cerebral)Spastic cerebral palsy NOS

Primary outcomes

1

Description
joints kinematic(sagittal,frontal & transverse plane)
Timepoint
before and immediately after applying KT
Method of measurement
3D motion analysis

2

Description
speed
Timepoint
before and immediately after applying KT
Method of measurement
motion analysis(meter/second)

3

Description
stride length
Timepoint
before and immediately after applying KT
Method of measurement
motion analysis(meter)

Secondary outcomes

empty

Intervention groups

1

Description
In this research kinesiotape use for treatment and 3D motion analysis system use for assessment. Each sample evaluate in 2 session(before and after of applying of KT). Kinesiotape use spiral shape (it started at the lateral malleolus and fix it at iliac crest of opposite site
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Education of Exceptional Children
Full name of responsible person
Ali Maktab dar
Street address
Adjacent to the Directorate General of Schools Renovation, Moadel Ave., Haft tir Ave. Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Scince
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Scince
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
SUMS School of Rehabilitation Science
Full name of responsible person
Sara Kayedi
Position
Masters student
Other areas of specialty/work
Street address
Abiverdi Ave., Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3224 8745
Fax
Email
sk.skayedi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
SUMS School of Rehabilitation Science
Full name of responsible person
Amin Kordi Yoosefinejad
Position
Assistant Professer
Other areas of specialty/work
Street address
Abiverdi Ave., Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 917 915 0589
Fax
Email
yoosefinejad@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
SUMS School of Rehabilitation Science
Full name of responsible person
Sara Kayedi
Position
Masters Student
Other areas of specialty/work
Street address
Abiverdi Ave., Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3224 8745
Fax
Email
sk.skayedi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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