Protocol summary
-
Study aim
-
1. Extraction of clinical, physical content, exercises or skills related to cognitive motor rehabilitation of stroke patients in daily life activities.
2. Development of serious game software based on virtual reality according to the life cycle method of game development.
3. Evaluating the sense of presence in a serious virtual reality game and evaluating its effectiveness.
-
Design
-
- Eligible participants were randomly assigned to the control group (i.e., standard medical care) or the experimental group (i.e., standard medical care plus playing a serious game) using a random number generator.
-
Settings and conduct
-
- Patients with stroke tested from a serious game based on virtual reality consisting of a virtual world with items related to motor activities of daily life (eating, cutting fruit, combing, opening a door, talking on a mobile phone, taking a bath) - cognitive (recall, sequence and awareness) installed on the VIVE Cosmos model virtual reality system along with two hand controllers that act as the patient's hands.
-
Participants/Inclusion and exclusion criteria
-
Six months have passed (according to the effectiveness of the intervention) after the stroke and I have a stable and cooperative clinical condition.
-
Intervention groups
-
- Basic tests are done one week before the first session and post-intervention tests are done one week after the last session for all subjects.
- Three half-hour training sessions to learn how to use virtual reality equipment and serious gaming environment and how to deal with rehabilitation items of daily life activities before starting the study.
- The evaluator will only participate in pre- and post-intervention evaluations and will be blind to the assignment of the participating group.
-
Main outcome variables
-
Cognitive motor rehabilitation of stroke patients
General information
-
Reason for update
-
Blinding of individuals was added due to forgetfulness in registration.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20240517061821N1
Registration date:
2024-07-25, 1403/05/04
Registration timing:
prospective
Last update:
2025-02-13, 1403/11/25
Update count:
1
-
Registration date
-
2024-07-25, 1403/05/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-09-22, 1403/07/01
-
Expected recruitment end date
-
2024-10-22, 1403/08/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Designing and evaluating a serious game based on virtual reality in order to promote cognitive motor rehabilitation of stroke patients in daily life activities
-
Public title
-
Designing and evaluating a serious game based on virtual reality in order to promote cognitive motor rehabilitation of stroke patients in daily life activities
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
It has been sprayed for six months (according to the effectiveness of the intervention) after a stroke
Have a stable and cooperative clinical condition
Participants had to score above 22 on the Minimal or Summary Mental Status Examination (MMSE) for cognitive characteristics
Scored higher than 18 in Vogel-Meier assessment (upper limb) (Persian version) to evaluate sensorimotor function.
It is possible to work with the Purdue pegboard tool to check finger function.
Exclusion criteria:
Physical inability to independently use the virtual reality system (that is, both limbs do not have the necessary movement function or have less movement, which is determined by the Fogel-Meier and Purdue pegboard tests.
Vision issues (eg, visual impairment, also report any metal implants due to orthopedic conditions or other neurological disorders such as Parkinson's disease, vestibular defects, peripheral neuropathy, or unstable epilepsy).
Such as lack of awareness of the environment, forgetfulness, loss or cases that did not receive the required score in the Mental Status Test (MMSE).
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
20
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The randomization method is simple, it is an individual randomization unit using statistical software.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Assessors and patients are blinded to the scenarios and assignments.
-
Placebo
-
Not used
-
Assignment
-
Other
-
Other design features
-
Two groups were randomly selected: the experimental group and the control group
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2024-04-22, 1403/02/03
-
Ethics committee reference number
-
IR.TBZMED.REC.1403.077
Health conditions studied
1
-
Description of health condition studied
-
Cognitive motor rehabilitation of stroke patients
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Level of cognitive rehabilitation and motor rehabilitation
-
Timepoint
-
One week before the start of the study and one week after the study
-
Method of measurement
-
Persian version of the Vogel-Meier Scale (PFMA) for upper limb assessment - total score Persian version of the Independent Function Measure (PFIM) for assessing personal performance and mental state examination (MMSE) for assessing the patient's cognitive status
Intervention groups
1
-
Description
-
Intervention group: 10 people in the experimental group (i.e. standard medical care plus playing a serious game), eight weeks of intervention including 16 sessions, each session lasting 30 minutes.
-
Category
-
Rehabilitation
2
-
Description
-
Control group: 10 people in the control group who only receive standard medical care in eight weeks of intervention including 16 sessions, each session lasting 30 minutes.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tabriz University of Medical Sciences
-
Proportion provided by this source
-
50
-
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
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
-
Not applicable