Investigation the effect of environment̉al exercises (physical and virtual reality environment) on the brain reorganization, molecular parameters and behavioral functions (cognitive and motor) in the chronic stroke patients
1. Investigation the effect of environment̉al exercises (physical and virtual reality environment) on the brain reorganization, brain-derived neurotrophic factor and cognitive and motor functions in the chronic stroke
2. Investigating the interactive effect of the type of environment̉al exercises (physical environment and virtual reality environment) and Atorvastatin on the brain reorganization, brain-derived neurotrophic factor and cognitive and motor functions in the chronic stroke
Design
Three parallel group,12 people per group، simple non-probability sampling, double blind, pre & post treatment assessment, 3 month follow up, 3 month cognitive-motor dual task training
Settings and conduct
National Molecular- Cellular and Imaging Laboratories, Clinics and Research Centers of Therapy. Blind blind, unaware of evaluators and patients of how to group patients
Participants/Inclusion and exclusion criteria
Inclusion criteria:
first stroke
The last 6-24 months since the lesion
65-35 years
The ability to walk at least 10 m without auxiliary equipment
No history of falling over the past 6 months
Acceptable level of cognitive performance
No hemi neglect
No history of other neurological problems, orthopedics and upper limb surgeries involved
Criteria for Receiving and taking Atorvastatin
Damage to the middle cerebral artery as a cause of stroke
Ability to read and write
Understandable speech
No vision problems
exclusion criteria:
Falling during tests and exercises
Failure to cooperate properly and correct implementation of the instructions
Intervention groups
1. not receive any exercise
2. take exercises in the physical environment.
3. receive exercises in the virtual reality environment.
Main outcome variables
Balance and Mobility; Working memory; Response Inhibition; executive Function; Serum Level of Brain-derived Growth Factor; Brain Volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180619040156N1
Registration date:2018-10-20, 1397/07/28
Registration timing:prospective
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Sohaila Fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4606
Email address
fallah.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-29, 1397/08/07
Expected recruitment end date
2019-06-24, 1398/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of environment̉al exercises (physical and virtual reality environment) on the brain reorganization, molecular parameters and behavioral functions (cognitive and motor) in the chronic stroke patients
Public title
Investigation the effect of cognitive and motor exercises on improving the performance of chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Experience the first stroke
Passed for 6-24 months after lesion
Having ages between 35-65 years
Ability to walk at least 10 meters without auxiliary equipment
No history of falling over the past 6 months according to the patient's own report
Having an acceptable level of cognitive performance means a score of over 24 in the Mini Mental Status Examination (MMSE) test.
Not having hemi neglect using the Star Cancellation test
Not having any history of other neurological problems, orthopedics and upper limb surgeries involved according to medical records, patient's or patient's report or observation of the examiner
Having the criteria for receiving and consuming Atorvastatin drug on the basis of a neurologist's diagnosis
Central cerebral artery injury as the cause of stroke
Ability to read and write
Having understandable speech
The lack of vision problems has not been resolved
Exclusion criteria:
Falling during assessments and exercises
Failure to cooperate properly and correct implementation of the instructions during the tests and exercises.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
3
More than 1 sample in each individual
Number of samples in each individual:
12
Sampling are done in an unpredictable way (convenience) and grouping is done randomly
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
trials are double-blind, which means that neither Data analyser nor the outcome assessors know which people are getting which treatments
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
Street address
Hemmat Highway . Iran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
ir.iums.REC.1397.150
Health conditions studied
1
Description of health condition studied
chronic stroke
ICD-10 code
Z82.3
ICD-10 code description
Family history of stroke
Primary outcomes
1
Description
Balance and upper and lower extremity mobility assessments (behavioral tests)
Timepoint
Before interventions, immediately after intervention, 3 months after intervention
Method of measurement
Timed up go test, functional reach test, berg test, fugl meyer test
2
Description
Cognitive Assessments (Behavioral Tests)
Timepoint
Before interventions, immediately after intervention, 3 months after intervention
Method of measurement
Wechsler test, Wisconsin test, Stroop test
3
Description
serum levels of brain-derived growth factor (molecular laboratory tests)
Timepoint
Before interventions, immediately after intervention, 3 months after intervention
Method of measurement
Brain derived neurotrophic factor analysis
4
Description
structural changes in various brain regions (laboratory imaging test)
Timepoint
Before interventions, immediately after intervention, 3 months after intervention
Method of measurement
magnetic resonance imaging
Secondary outcomes
1
Description
Changes in fear of falling
Timepoint
Before and after intervention and 3 months after intervention
Method of measurement
Activities-based balance confidence scale (ABC)
2
Description
Quality of life score
Timepoint
Before and after intervention and 3 months after intervention
Method of measurement
Short Form (36) Health Survey (SF-36)
3
Description
changes in fatigue levels
Timepoint
Before and after intervention and 3 months after intervention
Method of measurement
Multidimensional Fatigue Symptom Inventory-Short Form
Intervention groups
1
Description
Intervention group: Stroke patients receiving cognitive-motorized physical training in the physical environment and rehabilitation routine interventions
Category
Rehabilitation
2
Description
Intervention group: Stroke patients undergoing cognitive-motor-physical exercises in the virtual reality environment and rehabilitation routine interventions
Category
Rehabilitation
3
Description
Control group: Stroke patients receiving only rehabilitation routine interventions
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2687
Email
joghataei@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
Soheila Fallah
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2687
Email
fallah.s@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soheila Fallah
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2687
Email
fallah.s@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soheila Fallah
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2687
Email
fallah.s@tak.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In order to be trusted in the patient's personal information, their data is encoded and then shared with other researchers.
When the data will become available and for how long
After the completion of the design and documentation of the obtained data, the information is provided to the researchers. It takes about 1 year to complete this documentation.
To whom data/document is available
All researchers in the field of neurological diseases will have access to this information
Under which criteria data/document could be used
Other researchers can access the information after submitting an abstract of their research plan.
From where data/document is obtainable
by Email
sohailafallah66@gmail.com
What processes are involved for a request to access data/document
By submitting the abstract of the project and by email, it is provided