designing and adaptation of task oriented intervention using virtual reality and comparing the effectivness with usaual occupational therapy on participation and performance in people with cerebral palsy
designing and adaptation of task oriented intervention using virtual reality and comparing the effectiveness with usual occupational therapy on participation and performance in people with cerebral palsy
Design
The samples are selected from among people with cerebral palsy referring to rehabilitation centers The sampling method is simple non-probability,they are randomly divided into two intervention and control groups and it is done by sealed envelope method. The sample size is based on the primary outcome at least 22 people, who will enter 30 people. In the clinical trial phase, The samples are randomly divided into intervention and control groups.The control group of conventional occupational therapy exercises and the intervention group will receive the virtual reality program (SANA software technology) in addition to conventional intervention
Settings and conduct
blinding: after selecting the samples, they were randomly divided into two intervention and control groups and it will be done by a researcher who has no role in the evaluation and treatment using the sealed envelope method. The place where the study is carried out is in the occupational therapy Rehabilitation clinic and Mofaqian's Knowledge-Based Rehabilitation Center
Participants/Inclusion and exclusion criteria
inclusion criteria
Diagnosis of cerebral palsy: mild and moderate
Age: 8 to 12
GMFCS I to III
MACS I to III
SPARCLE: up to 70
exclusion criteria
Inability to understand instructions and implement therapeutic interventions
Intervention groups
The control group will receive conventional occupational therapy exercises including clinical task-based intervention based on conventional occupational therapy guidelines, and the intervention group will receive task-based virtual reality program along with conventional occupational therapy exercises
Main outcome variables
Occupational performance
Participation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230907059375N1
Registration date:2024-02-01, 1402/11/12
Registration timing:registered_while_recruiting
Last update:2024-02-01, 1402/11/12
Update count:1
Registration date
2024-02-01, 1402/11/12
Registrant information
Name
Madineh Hassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4612 7282
Email address
madinehh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
designing and adaptation of task oriented intervention using virtual reality and comparing the effectivness with usaual occupational therapy on participation and performance in people with cerebral palsy
Public title
Comparsion of virtual reality task oriented intervention with usual occupational therapy on participation and performance in people with cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 8_12 years old
levels I I to III of the Gross Motor Function Classification System (GMFCS)
2) levels I I to III of the Manual Ability Classification System
levels of SPARCLE: up to 70
Exclusion criteria:
Existence of vision and hearing problems
Existence of disorders and associated diseases
Having a seizure
Botulinum toxin injection in the last 6 months
Inability to understand instructions and perform therapeutic interventions
Age
From 8 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be done in the form of blocks of four in a ratio of one to one (1:1) in two intervention and control groups by a researcher who is not involved in the evaluation and treatment and is outside the research team and will be done by sealed envelopes. After allocating group people, each person will be placed inside secret envelopes that are not known.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluators are among the blind group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Intervention group: The intervention group will receive the task-based virtual reality program along with conventional occupational therapy exercises. The virtual reality technology of the Sana software, which is used by the engineers of Knowledge base Institute with the Kinect device, where the patients are placed on a chair without handles and firmly at a distance of 2 meters from the Kinect camera, in a standing or sitting position, They will perform the virtual reality exercises in five different activities including, random reach, tracking, library and rotate wheel in the clinic and under the supervision of the therapist..
Category
Rehabilitation
2
Description
Control group: The control group will receive conventional occupational therapy intervention based on a neurodevelopmental approach. which was compiled based on the results of the latest guidelines and expert panel meetings and common occupational therapy in Iran.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation faculty
Full name of responsible person
Madineh hassani
Street address
Mirdamad blv
City
Tehran
Province
Tehran
Postal code
6791954874
Phone
+98 83 4613 6132
Email
Madinehh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
ِDr Mehdi Alizadeh
Street address
shahnazari streetm Mirdamad Blv
City
تهران
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
madinehh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical 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
2
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Musazadeh
Street address
Shahid Hammat Sabway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 8051
Email
mousavizadeh.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical 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
Iran University of Medical Sciences
Full name of responsible person
Dr Mehdi Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
ShahNazari Street, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8052
Email
Madinehh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Madineh Hassani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Mehmansara street, Shohada Square
City
Paveh
Province
Kermanshah
Postal code
6791954874
Phone
+98 83 4612 7282
Email
madinehh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Madineh Hassani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Mehmansara street, Shohada Square
City
Paveh
Province
Kermanshah
Postal code
6791954874
Phone
+98 83 4612 7282
Email
madineh@gmail.com
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