Effects of Vestibular Rehabilitation Interventions on Fatigue, Depression, and Activities of Daily Living in Armed Forces Retirees with Stroke: A Randomized Controlled Trial Study
Effects of Vestibular Rehabilitation Interventions on Fatigue, Depression, and Activities of Daily Living in Armed Forces Retirees with Stroke: A Randomized Controlled Trial Study
Design
A single randomized clinical trial, with a parallel group of 25 patients
Settings and conduct
Sampling from Hospitals affiliated with the Aja University of Medical Sciences (in Tehran city) is done. After the eligible patients fill out the consent form, they will be randomly assigned to two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
History of Only one cerebrovascular accident
At least a score of 21 in the Mini-mental state examination(MMSE)
absence of severe visual and auditory disorders; lack of diabetes; osteoarthritis and osteoporosis, especially in the lower limbs; any other neurological disease
The ability to walk with or without auxiliary equipment
Exclusion criteria:
Failure to co-operate with the patient during tests and exercises
Failure to return a patient to perform second-stage tests after interventions
Patients who change their medication regimen during the intervention
Intervention groups
Two groups: 1) control group (Common Rehabilitation Interventions), 2) intervention group (Common Rehabilitation Interventions+Vestibular Rehabilitation Interventions)
Main outcome variables
Fatigue, Depression, and Activities of Daily Living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090904002415N3
Registration date:2022-01-10, 1400/10/20
Registration timing:registered_while_recruiting
Last update:2022-01-10, 1400/10/20
Update count:1
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Bahador Asadi Khansari
Name of organization / entity
Army University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 1487
Email address
peiman_asadi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-26, 1400/10/05
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Vestibular Rehabilitation Interventions on Fatigue, Depression, and Activities of Daily Living in Armed Forces Retirees with Stroke: A Randomized Controlled Trial Study
Public title
The Effects of Vestibular Rehabilitation on Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of Only one cerebrovascular accident
At least a score of 21 in Mini-mental state examination(MMSE)
absence of severe visual and auditory disorders; lack of diabetes; osteoarthritis and osteoporosis, especially in the lower limbs; any other neurological disease
The ability to walk with or without auxiliary equipment
Exclusion criteria:
Failure to co-operate with the patient during tests and exercises
Failure to return a patient to perform second-stage tests after interventions
Patients who change their medication regimen during the intervention
Age
From 40 years old to 90 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Available samples of stroke patients referred to Golestan and Imam Reza hospitals affiliated to Aja University of Medical Sciences in Tehran selected according to the selected inclusion criteria and after agreeing to participate in this study and signing the consent form, they will be divided into two groups of control and intervention by complete randomization method (sealed envelope method). In absolute random method (envelope and paper method), the name of groups will be written on a piece of paper and put in an envelope and the participants will be asked to choose one of the papers randomly then the patient will be placed in the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The person or people who evaluate the outcome or non-outcome of the outcome in the participants or collect data on the outcome variables.
in this study, All primary and secondary assessments are performed by an experienced occupational therapist working with stroke patients who have already been taught the tests by the researcher and are completely blind to the type of intervention in both intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Fatemi St., Etemadzadeh St., Army University of Medical Sciences, Ethics Committee
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-12-22, 1400/10/01
Ethics committee reference number
IR.AJAUMS.REC.1400.245
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67
ICD-10 code description
Other cerebrovascular diseases
Primary outcomes
1
Description
Fatigue
Timepoint
Before intervention, after intervention
Method of measurement
Fatigue Impact Scale
2
Description
Depression
Timepoint
Before intervention, after intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Independence in the activities of daily living
Timepoint
Before and after the intervention
Method of measurement
Barthel Index (Independence in Basic Activities of Daily Living) and Lawton IADL Scale (Independence in Instrumental of Daily Living)
Intervention groups
1
Description
Intervention group: In addition to routine rehabilitation exercises, they receive vestibular rehabilitation interventions that include a 26-exercise protocol classified into five general sections. These five sections include body exercises without standing on the ground, body in half-kneeling on the ground, body standing on a trampoline, walking, and finally exercises related to eye movements.
Category
Rehabilitation
2
Description
Control group: Routine rehabilitation exercises include muscle stretching, positioning, muscle strengthening, and range of motion exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Bahador Asadi Khansari
Street address
Pasdaran St. (5th Golestan), Sayad Shirazi Highway
City
Tehran
Province
Tehran
Postal code
1668619551
Phone
+98 21 2254 9096
Email
peiman_asadi@ajaums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Bahador Asadi Khansari
Street address
West Fatemi St. - North Shahid Etemadzadeh St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6356
Email
peiman_asadi@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zashk
Street address
Fatemi St., Etemadzadeh St., Aja University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
peiman_asadi@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Amin Ghaffari
Position
Elite
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Elite Circle, Aja University of Medical Sciences, Etemadzadeh St.,Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8833 7920
Email
amin.ghaffari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bahador Asadi Khansari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
North Shahid Etemadzadeh St.,West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6356
Email
peiman_asadi@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Amin Ghaffari
Position
Elite
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Elite Circle, Aja University of Medical Sciences, Etemadzadeh St.,Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8833 7920
Email
amin.ghaffari@yahoo.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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Not Decided
When the data will become available and for how long
Not Decided
To whom data/document is available
Not Decided
Under which criteria data/document could be used
Not Decided
From where data/document is obtainable
Not Decided
What processes are involved for a request to access data/document