Protocol summary
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Study aim
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Effects of Vestibular Rehabilitation Interventions on Fatigue, Depression, and Activities of Daily Living in Armed Forces Retirees with Stroke: A Randomized Controlled Trial Study
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Design
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A single randomized clinical trial, with a parallel group of 25 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Two groups: 1) control group (Common Rehabilitation Interventions), 2) intervention group (Common Rehabilitation Interventions+Vestibular Rehabilitation Interventions)
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Main outcome variables
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Fatigue, Depression, and Activities of Daily Living
General information
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Reason for update
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1- In order to measure the patient's ability, the ability to walk with and without an aid device as one of the criteria for inclusion in the study was supplemented by adding the Functional Ambulation Classification test.
2- Due to the implementation of interventions on stroke patients suffering from fatigue, the inclusion criteria for fatigue assessment based on the Fatigue Assessment Scale was added.
3- In the primary outcomes section, in addition to the Fatigue Impact Scale, the Fatigue Assessment Scale was added to the questionnaires to evaluate the effect of vestibular rehabilitation interventions on fatigue in order to increase the validity and effectiveness of the interventions.
4- Due to the small number of available samples (Armed Forces retirees with stroke) for two primary outcomes simultaneously (fatigue and depression together), the depression variable was transferred from the primary outcomes section to the secondary outcomes section.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090904002415N3
Registration date:
2022-01-10, 1400/10/20
Registration timing:
registered_while_recruiting
Last update:
2022-04-18, 1401/01/29
Update count:
1
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Registration date
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2022-01-10, 1400/10/20
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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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2021-12-26, 1400/10/05
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Expected recruitment end date
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2022-04-19, 1401/01/30
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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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Effects of Vestibular Rehabilitation Interventions on Fatigue, Depression, and Activities of Daily Living in Armed Forces Retirees with Stroke: A Randomized Controlled Trial Study
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Public title
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The Effects of Vestibular Rehabilitation on Stroke Patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 (score of 3 or higher in the Functional Ambulation Classification)
Score more than 24 on the Fatigue Assessment Scale
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
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Age
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From 40 years old to 90 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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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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2021-12-22, 1400/10/01
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Ethics committee reference number
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IR.AJAUMS.REC.1400.245
Health conditions studied
1
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Description of health condition studied
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Stroke
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ICD-10 code
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I67
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ICD-10 code description
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Other cerebrovascular diseases
Primary outcomes
1
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Description
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Fatigue
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Fatigue Impact Scale, Fatigue assessment scale
Secondary outcomes
1
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Description
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Independence in the activities of daily living
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Timepoint
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Before and after the intervention
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Method of measurement
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Barthel Index (Independence in Basic Activities of Daily Living) and Lawton IADL Scale (Independence in Instrumental of Daily Living)
2
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Description
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Depression
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Beck Depression Inventory
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: Routine rehabilitation exercises include muscle stretching, positioning, muscle strengthening, and range of motion exercises.
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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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Artesh 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Not Decided
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When the data will become available and for how long
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Not Decided
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To whom data/document is available
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Not Decided
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Under which criteria data/document could be used
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Not Decided
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From where data/document is obtainable
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Not Decided
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What processes are involved for a request to access data/document
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Not Decided
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Comments
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