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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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History
# Registration date Revision Id
2 2022-04-17, 1401/01/28 223034
1 2022-01-10, 1400/10/20 212430
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  • General information

    empty
    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.
    empty
    ۱- معیار های ورود به مطالعه از جمله توانایی راه رفتن با اضافه کردن تست مقیاس عملکردی جابجایی به آن در راستای قابل اندازه گیری بودن توانایی بیمار تکمیل تر گردید. ۲- با توجه به اجرای مداخلات بر روی بیماران سکته مغزی که دچار خستگی هستند،معیار ورود برای ارزیابی خستگی بر اساس مقیاس ارزیابی خستگی اضافه شد. ۳- در بخش پیامدهای اولیه،علاوه بر مقیاس سنجش خستگی،مقیاس اندازه گیری خستگی نیز برای بررسی اثر مداخلات توانبخشی دهلیزی بر روی خستگی به پرسشنامه ها در راستای افزایش اعتبار و اثر بخشی مداخلات اضافه گردید. ۴- به توجه به کم بودن تعداد نمونه های در دسترس(بازنشستگان نیروهای مسلح مبتلا به سکته مغزی) برای دو پیامد اولیه بصورت همزمان(خستگی و افسرگی با هم)،متغیر افسردگی از بخش پیامد های اولیه به بخش پیامدهای ثانویه منتقل شد.
    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
    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
    داشتن سابقه تنها یک بار سکته مغزی
    نمره حداقل 21 در آزمون مختصر وضعیت شناختی (MMSE)
    عدم وجود اختلالات شديد بينائي و شنوایی; نداشتن دیابت ، استئوپروز و استئوآرتریت بویژه در اندام تحتانی; هرگونه بیماری نورولوژیکی دیگر
    توانایی راه رفتن با و یا بدون وسیله کمکی
    داشتن سابقه تنها یک بار سکته مغزی
    نمره حداقل 21 در آزمون مختصر وضعیت شناختی (MMSE)
    عدم وجود اختلالات شديد بينائي و شنوایی; نداشتن دیابت ، استئوپروز و استئوآرتریت بویژه در اندام تحتانی; هرگونه بیماری نورولوژیکی دیگر
    توانایی راه رفتن با و یا بدون وسیله کمکی(کسب نمره ۳ یا بالاتر در تست طبقه بندی جابجایی عملکردی)
    کسب نمره بیشتر از ۲۴ در تست ارزیابی خستگی

  • Primary outcomes

    #1
    Fatigue Impact Scale
    Fatigue Impact Scale, Fatigue assessment scale
    مقیاس سنجش خستگی
    مقیاس سنجش خستگی، مقیاس اندازه گیری خستگی
    #2
    Depression
    empty
    افسردگی
    empty
    Before intervention, after intervention
    empty
    قبل از مداخله،بعد از اتمام مداخله
    empty
    Beck Depression Inventory
    empty
    مقیاس سنجش شدت افسردگی بک
    empty

  • Secondary outcomes

    #1
    empty
    Depression
    empty
    افسردگی
    empty
    Before intervention, after intervention
    empty
    قبل از مداخله،بعد از اتمام مداخله
    empty
    Beck Depression Inventory
    empty
    مقیاس سنجش شدت افسردگی بک

  • Recruitment centers

    #1
    Name of recruitment center - English: Golestan Hospital
    Name of recruitment center - Persian: بیمارستان گلستان
    Full name of responsible person - English: Bahador Asadi Khansari
    Full name of responsible person - Persian: بهادر اسدی خوانساری
    Street address - English: Pasdaran St. (5th Golestan), Sayad Shirazi Highway
    Street address - Persian: خیابان پاسداران(گلستان پنجم) ،اتوبان صياد شيرازي
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1668619551
    Phone: +98 21 2254 9096
    Fax:
    Email: peiman_asadi@ajaums.ac.ir
    Web page address:
    Name of recruitment center - English: Golestan Hospital
    Name of recruitment center - Persian: بیمارستان گلستان
    Full name of responsible person - English: Bahador Asadi Khansari
    Full name of responsible person - Persian: بهادر اسدی خوانساری
    Street address - English: Sayad Shirazi Highway, Pasdaran St. (5th Golestan),
    Street address - Persian: خیابان پاسداران(گلستان پنجم) ،اتوبان صياد شيرازي
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1668619551
    Phone: +98 21 2254 9096
    Fax:
    Email: peiman_asadi@ajaums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Bahador Asadi Khansari
    Full name of responsible person - Persian: بهادر اسدی خوانساری
    Street address - English: West Fatemi St. - North Shahid Etemadzadeh St.
    Street address - Persian: خیابان فاطمی غربی- خیابان شهید اعتمادزاده شمالی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 8609 6356
    Fax:
    Email: peiman_asadi@ajaums.ac.ir
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Bahador Asadi Khansari
    Full name of responsible person - Persian: بهادر اسدی خوانساری
    Street address - English: North Shahid Etemadzadeh St., West Fatemi St.
    Street address - Persian: خیابان فاطمی غربی- خیابان شهید اعتمادزاده شمالی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 8609 6356
    Fax:
    Email: peiman_asadi@ajaums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mojtaba Yousefi Zashk
    Full name of responsible person - Persian: مجتبی یوسفی زشک
    Street address - English: Fatemi St., Etemadzadeh St., Aja University of Medical Sciences
    Street address - Persian: خ فاطمی، خ اعتمادزاده، دانشگاه علوم پزشکی ارتش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 8802 8350
    Fax:
    Email: peiman_asadi@ajaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mojtaba Yousefi Zashk
    Full name of responsible person - Persian: مجتبی یوسفی زشک
    Street address - English: Aja University of Medical Sciences, Etemadzadeh St.,Fatemi St.
    Street address - Persian: خ فاطمی، خ اعتمادزاده، دانشگاه علوم پزشکی ارتش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 8802 8350
    Fax:
    Email: peiman_asadi@ajaums.ac.ir
    Web page address:

Protocol summary

Study aim
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
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.
Acronym
IRCT registration information
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
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 (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
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, Fatigue assessment scale

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)

2

Description
Depression
Timepoint
Before intervention, after intervention
Method of measurement
Beck Depression Inventory

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
Sayad Shirazi Highway, Pasdaran St. (5th Golestan),
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
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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zashk
Street address
Aja University of Medical Sciences, Etemadzadeh St.,Fatemi St.
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
Not Decided
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