Determining the effect of virtual reality technique on the balance and walking speed of children 5-12 years old spastic cerebral pals
Design
Clinical trials with control groups, with parallel, two-way blind, randomized groups, were used to randomize the software.
Settings and conduct
The present study was a randomized clinical trial of two suckers that was performed in Yekta and Raha occupational therapy clinics in Khorramabad city. Walking was measured by walking speed. The control group received occupational therapy exercises as 30-minute sessions twice a week for 6 weeks. In addition to occupational therapy exercises, the intervention group also used the virtual reality technique. The intervention phase in this study was 18 20-minute sessions that were held for 6 weeks and 3 times a week. In each session, participants performed selective games
Participants/Inclusion and exclusion criteria
Age between 5 and 12 years, GMFCS II, I level, no use of sedatives during the intervention time, no hearing and vision impairment that cannot be compensated by assistive devices, no treatment-resistant seizures.
Criteria for non-entry: non-cooperation of the child and absence of more than three sessions in treatment sessions
Intervention groups
The control group received occupational therapy exercises as 30-minute sessions twice a week for 6 weeks
In addition to occupational therapy exercises, the intervention group also used virtual reality techniques
Main outcome variables
Walking speed, balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047094N1
Registration date:2020-06-07, 1399/03/18
Registration timing:retrospective
Last update:2020-06-07, 1399/03/18
Update count:0
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Maryam naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 9713
Email address
naderi.maryam0071@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-23, 1399/02/04
Expected recruitment end date
2020-05-25, 1399/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the Effect of Virtual Reality Practice on balance and Walking speed In children with spastic cerebral palsy
Public title
the Effect of Virtual Reality on cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with spastic cerebral palsy range in age from 5 to 12 years
Be based on GMFCS classification systems at levels I and II
Do not use sedatives during the intervention
Lack of any hearing or vision defects that cannot be compensated by assistive devices and impair the child's performance
Lack of treatment-resistant seizures
Exclusion criteria:
Lack of cooperation of the child in medical sessions
Absence of more than three sessions in treatment sessions
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The present study was a randomized double-blind clinical trial. The number of 30 children with spastic cerebral palsy was selected from the available community and after filling out the consent form, they were randomly divided into control and intervention groups using the software. And the intervention took place on different days so that the children and families could remain unaware of the child's presence in the control and intervention group. Also, the occupational therapist who performed the assessments was unaware of the division of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, control and intervention group meetings were held on different days so that children and families were unaware of the child's presence in the control and intervention group. Also, the occupational therapist who performed the assessments was unaware of the division of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway, Yemen St., Shahid Arabi St., next to Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.206
Health conditions studied
1
Description of health condition studied
cerabla palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
Equilibrium score on functional tests,
Timepoint
After the intervention and 3 months after the end of the intervention
Method of measurement
Functional tests
2
Description
walking speed score on functional tests
Timepoint
After the intervention and 3 months after the end of the intervention
Method of measurement
Functional tests
Secondary outcomes
empty
Intervention groups
1
Description
control group: receive occupational therapy exercises alone.
Category
Rehabilitation
2
Description
Intervention group : receive occupational therapy exercises along with receiving therapeutic interventions using virtual reality
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Raha and Yekta Occupational Therapy Center
Full name of responsible person
Maryam Naderi
Street address
Enqelab St., Quds Alley, Farabi Doctors Building
City
Khorramabad
Province
Lorestan
Postal code
6817753978
Phone
+98 66 3340 9713
Email
naderi.maryam0071@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St., Shahid Arabi St., next to Taleghani Hospita
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kardarmani Raha
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Naderi
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Arman1
City
Khorramabad
Province
Lorestan
Postal code
6817753978
Phone
+98 66 3340 9713
Email
naderi.maryam0071@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Kalantari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Damavand Street in front of Bouali Hospital
City
Tehran
Province
Tehran
Postal code
6817753978
Phone
+98 21 7754 2057
Email
MN_kalantari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Naderi
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damavand Street in front of Bouali Hospital
City
Tehran
Province
Lorestan
Postal code
6817753978
Phone
+98 66 3340 9713
Email
naderi.maryam0071@gmail.com
Web page address
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