Protocol summary

Summary
Limited hand function is a characteristic of the movement disorders in children with Cerebral Palsy which leads to disability in performing activities of daily living, work and play. Materials and methods : In this Randomized Clinical Trial and single-blind study , 26 children (3-6 years old) with spastic diplegic cerebral palsy were selected by convenient and simple sampling and randomly divided into two intervention and control groups. During the study for 12 days, Control group received traditional occupational therapy treatment (Neuro-Developmental Treatment) and intervention group received wrist KinesioTaping, moreover. Assessment tools were QUEST for evaluating quality of upper extremity skills and Modified Ashworth Scale for assessing spasticity of wrist, before and after intervention, in both groups. Furthermore, in order to determining the permanency of Kinesio Taping effects, assessments were repeated in intervention group, two weeks later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112208470N1
Registration date: 2012-02-04, 1390/11/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-04, 1390/11/15
Registrant information
Name
Roya Sadeghi Moghaddam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
l-lajvardi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-02-01, 1389/11/12
Expected recruitment end date
2011-05-01, 1390/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of wrist kinesio taping on hand function in children with spastic diplegic cerebral palsy
Public title
Investigating the effects of wrist kinesio taping on hand function in children with spastic diplegic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Complete consent for participation in research project; Diagnosis of spastic diplegic cerebral palsy; Age between 3-6 years; Wrist spasticity score was 1-2 according to modified ashworth scale; No contracture in upper extremities; No history of allergy or skin problems; No mental retardation and having good cognitive and awareness state to cooperate during the assessment; Not receiving any other treatment that may affect hand function during the study. Exclusion criteria: Unwillingness to participate in the present study; Develop of skin allergy; Orthopaedic conditions during the study.
Age
From 3 years old to 6 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Rehabilitation faculty of Tehran University of Medical Sciences,Nezam alley, Shahnazari street, Mirdamad blvd.
City
Tehran
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
1509/130/90

Health conditions studied

1

Description of health condition studied
spastic diplegic cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy

Primary outcomes

1

Description
Hand function
Timepoint
Before and after intervention and 2weeks after study
Method of measurement
Quality of Upper Extremity Skills Test

Secondary outcomes

1

Description
Spasticity of wrist flexor muscles
Timepoint
Before and after intervention and 2weeks after study
Method of measurement
Modified Ashworth Scale

Intervention groups

1

Description
Control group received traditional occupational therapy treatment (2 sessions every week).
Category
Rehabilitation

2

Description
Intervention group received wrist kinesio taping for 12 days in addition to traditional occupational therapy treatment (2sessions every week)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Vesal rehabilitation center
Full name of responsible person
Roya Sadeghi Moghaddam
Street address
No.47, Shahid Salmanian St., Imamreza Blvd., Azadegan Sq.
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research,Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Keshavarz Blvd., Ghods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research,Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Roya Sadeghi Moghaddam
Position
Master of science in Occupational therapy
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences,Nezam alley, Shahnazari street, Mirdamad blvd.
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
sadeghiOT@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Sadeghi Moghaddam
Position
Master of science in Occupational therapy
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences,Nezam alley, Shahnazari street, Mirdamad blvd.
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
sadeghiOT@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Sadeghi Moghaddam
Position
Master of science in Occupational therapy
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
SadeghiOT@yahoo.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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