Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Occupational performance
Participation
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230907059375N1
Registration date:
2024-02-01, 1402/11/12
Registration timing:
registered_while_recruiting
Last update:
2025-01-28, 1403/11/09
Update count:
1
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Registration date
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2024-02-01, 1402/11/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-10-23, 1402/08/01
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Expected recruitment end date
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2024-02-20, 1402/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Comparsion of virtual reality task oriented intervention with usual occupational therapy on participation and performance in people with cerebral palsy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 8 years old to 12 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the evaluators are among the blind group
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-07-03, 1402/04/12
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Ethics committee reference number
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IR.IUMS.REC.1402.310
Health conditions studied
1
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Description of health condition studied
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Cerebral Palsy
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ICD-10 code
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G80
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ICD-10 code description
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Cerebral palsy
Primary outcomes
1
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Description
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Participation: involvement in life situations
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Timepoint
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2 month
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Method of measurement
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Participation was measuring using COPM
Secondary outcomes
1
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Description
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visual perception
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Test of Visual Perceptual Skills
2
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Description
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Upper limb function
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Box and Block Test (BBT)
3
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Description
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Manual ability to perform daily activities
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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ABILHAND-kids
4
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Description
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Participation in daily life activities
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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children participation assessment scale (CPAS)
Intervention groups
1
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Description
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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..
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable