The aim of the present study is to improve upper limb performance in children with hemiplegic cerebral palsy. A total of fifteen children with hemiplegic cerebral palsy will be recruited and assigned into the following 3 groups, before the initiation of the intervention. The first group receives virtual reality with restraint that exercises are done with E-Link system, the second group receives only Virtual reality treatment without restraint, and the third group is control group, without any intervention. Measurement sessions are done at the baseline, after the intervention, and three month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010164945N1
Registration date:2011-01-21, 1389/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-21, 1389/11/01
Registrant information
Name
Hamid Reza Rostami
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3101
Email address
rostamihr@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-16, 1389/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy comparison between virtual reality and its modified form on children with hemiplegic CP
Public title
Efficacy comparison between virtual reality and its modified form on children with hemiplegic CP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hemiplegic Children, age between 3 and 10 Year, range of motion: 20 degrees in wrist joint and 10 degrees in MP and IP Joints from full flexion, standing balance
Exclusion criteria: Deformity, botolinium Toxin Therapy over 6 months prior to the study, history of seizure over 6 months prior to the study, balance problems
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz
City
Ahvaz
Postal code
Approval date
2010-06-19, 1389/03/29
Ethics committee reference number
U-89071
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
hand function
Timepoint
Baseline and 3 weeks and 3 months after the intervention
Method of measurement
functional test
Secondary outcomes
1
Description
speed and range of motion
Timepoint
Baseline and 3 weeks and 3 months after the intervention
Method of measurement
functional tests
Intervention groups
1
Description
First Group: virtual reality by E-Link system
Category
Rehabilitation
2
Description
Second Group: Virtual Reality by E-Link system with restraint of non involved upper limb
Category
Treatment - Drugs
3
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Hospitals
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mrs Jaderi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamid Reza Rostami
Position
Msc
Other areas of specialty/work
Street address
School of Rehabilitation Sciences
City
Ahvaz
Postal code
Phone
+98 935 525 5800
Fax
Email
rostamihr@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamid Reza Rostami
Position
Msc
Other areas of specialty/work
Street address
School of Rehabilitation Scienecs
City
Ahvaz
Postal code
Phone
+98 935 525 5800
Fax
Email
rostamihr@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamid Reza Rostami
Position
Other areas of specialty/work
Street address
City
Ahvaz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)