Effects of transcranial direct current stimulation with cognitive orientation to daily occupational performance versus neurodevelopmental treatment on motor based occupational performance of upper extremity in children with cerebral hemiplegia: a randomized clinical trial
Assessing the effect of transcranial direct current stimulation with cognitive orientation to daily occupational performance versus neurodevelopmental treatment on motor based occupational performance of upper extremity in children with cerebral hemiplegia
Design
This a randomized clinical trial, in which 36 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible children with cerebral hemiplegia who will refer to University of Welfare and Rehabilitation Sciences during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 7 to 12 years
Cerebral hemiplegia
The ability to establish verbal communication
Medium to high intelligence
Exclusion criteria:
A history of CO_OP treatment
A history of surgery or botulinum toxin injection in the last three months
Blindness
Deafness
Seizure
Intervention groups
Intervention group: Transcranial direct current stimulation with severity of 0.5 to 2 mA for 15 min plus cognitive orientation 10 sessions, each session for 45 min.
Control group: Transcranial direct current stimulation with severity of 0.5 to 2 mA for 15 min plus neurodevelopmental treatment 10 sessions, each session for 45 min
Main outcome variables
Primary outcome:
Assessing the occupational performance two weeks after treatment through physical examination
Assessing the performance of upper extremity two weeks after treatment through physical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N220
Registration date:2018-05-16, 1397/02/26
Registration timing:registered_while_recruiting
Last update:2018-05-16, 1397/02/26
Update count:0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of transcranial direct current stimulation with cognitive orientation to daily occupational performance versus neurodevelopmental treatment on motor based occupational performance of upper extremity in children with cerebral hemiplegia: a randomized clinical trial
Public title
Effects transcranial direct current stimulation with cognitive orientation to daily occupational performance versus neurodevelopmental treatment on motor based occupational performance of upper extremity in children with cerebral hemiplegia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 7 to 12 years
Cerebral hemiplegia
The ability to establish verbal communication
Medium to high intelligence
Exclusion criteria:
A history of CO_OP treatment
A history of surgery or botulinum toxin injection in the last three months
Blindness
Deafness
Seizure
Age
From 7 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Welfare and Rehabilitation Sciences
Street address
University of Welfare and Rehabilitation Sciences, Student Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.USWR.REC.1396.307
Health conditions studied
1
Description of health condition studied
Cerebral hemiplegia
ICD-10 code
G81.0
ICD-10 code description
Flaccid hemiplegia
Primary outcomes
1
Description
Assessing the occupational performance
Timepoint
Two weeks after treatment
Method of measurement
Through physical examination
2
Description
Assessing the performance of upper extremity
Timepoint
Two weeks after treatment
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Transcranial direct current stimulation with severity of 0.5 to 2 mA for 15 min plus cognitive orientation 10 sessions, each session for 45 min.
Category
Treatment - Other
2
Description
Control group: Transcranial direct current stimulation with severity of 0.5 to 2 mA for 15 min plus neurodevelopmental treatment 10 sessions, each session for 45 min
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Welfare and Rehabilitation Sciences
Full name of responsible person
Sahar Johari
Street address
University of Welfare and Rehabilitation Sciences, Student Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
saharjohari85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr Amir Masood Arab
Street address
University of Welfare and Rehabilitation Sciences, Student Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sahar Johari
Position
Student of Occupational Therapy
Latest degree
Master
Other areas of specialty/work
Occupational Medicine
Street address
University of Welfare and Rehabilitation Sciences, Student Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
saharjohari85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hojatolah Haghgoo
Position
Occupational Therapy Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Occupational Medicine
Street address
University of Welfare and Rehabilitation Sciences, Student Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
h.haghgoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available