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To compare the effect of visual restriction exercise and proprioception exercise in balance of stroke patients.

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History
# Registration date Revision Id
3 2020-05-17, 1399/02/28 134704
2 2020-05-16, 1399/02/27 134489
1 2020-04-15, 1399/01/27 129753
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  • General information

    2020-03-05, 1398/12/15
    2020-05-09, 1399/02/20
    2020-05-04, 1399/02/15
    2020-07-10, 1399/04/20
    empty
    Impossibility of sampling due to corona virus. The start date of sampling will be corrected on 02/20/1991.
    empty
    عدم امکان نمونه گیری به دلیل کرونا ویروس تاریخ شروع نمونه گیری 1399/02/20 اصلاح می گردد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Loghman hospital. Tehran, Iran
    Name of recruitment center - Persian: ایران- تهران -بیمارستان لقمان
    Full name of responsible person - English: Nahid Tahan
    Full name of responsible person - Persian: ناهید طحان
    Street address - English: street- Loghman hospital
    Street address - Persian: خیابان کمالی- بیمارستان لقمان حکیم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1333625445
    Phone: +98 21 5102 5345
    Fax:
    Email: tnpt2378@gmail.com
    Web page address:
    Name of recruitment center - English: Tabasom rehabilitation center
    Name of recruitment center - Persian: مرکز توانبخشی تبسم
    Full name of responsible person - English: Nahid Tahan
    Full name of responsible person - Persian: ناهید طحان
    Street address - English: No.26, West Baqerkhan st, Chamran highway, Tehran
    Street address - Persian: تهران، بزرگراه چمران، خیابان باقرخان غربی، پلاک 26
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1333625445
    Phone: +98 21 5102 5345
    Fax:
    Email: tnpt2378@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vice chancellor for research, Shahid Beheshti University of Medical Sciences
    Full name of responsible person - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي شهيد بهشتي
    Street address - English: Velnjac- Shahid Beheshti University of Medical Sciences
    Street address - Persian: ولنجک - دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 985717443
    Phone: +98 21 23781
    Fax:
    Email: info@sbmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Afshin Zarghi
    Full name of responsible person - Persian: دکتر افشین زرقی
    Street address - English: No.15, Yaman St, Arabi St, Next to Taleghani Hospital, Chamran High way
    Street address - Persian: بزرگراه چمران، مجاور بیمارستان طالقانی، خیابان اعرابی، خیابان یمن, پلاک ۱۵
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 985717443
    Phone: +98 21 23781
    Fax:
    Email: info@sbmu.ac.ir
    Web page address:

Protocol summary

Study aim
To compare effects of balance training on an unstable surface with balance training under visual deprivation conditions in persons with stroke
Design
A randomized, placebo-controlled clinical trial، parallel group trial with blinded outcome assessor and data analyzor .
Settings and conduct
All groups will recive general physical therapy exercise including muscle stretching and strengthening exercise Participants in the visual deprivation training group are going to instructed to perform balance training exercise on a firm floor while they are keeping their eyes closed. The unstable base group will perform balance training on a foam(unstable surface) with open eyes. Subjects in the control group are going to get standard physiotherapy treatment. Each exercise session consisted of 4 sets in 20 minutes with one minute of rest interval between each set. The interventions will carried out for one month, 3 sessions per week in the selective stroke rehabilitation center in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 25-65 and stroke at least 6 months ago. Exclusion criteria: Any musculoskeletal, cardiac or respiratory problems that impedes the exercise therapy.
Intervention groups
Grouping consisted of 3 groups of 15 persons: Intervention group 1: Exercise on stable surface with visual restriction, Intervention group 2 Exercise on unstable surface with open eyes and control group
Main outcome variables
Timed Up and Go (TUG), Five Times Sit to Stand (FTSS) and Four Square Step (FSS) tests at baseline and after completing their intervention

General information

Reason for update
Impossibility of sampling due to corona virus. The start date of sampling will be corrected on 02/20/1991.
Acronym
IRCT registration information
IRCT registration number: IRCT20190812044516N1
Registration date: 2020-04-15, 1399/01/27
Registration timing: prospective

Last update: 2020-05-16, 1399/02/27
Update count: 2
Registration date
2020-04-15, 1399/01/27
Registrant information
Name
Nahid Tahan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1723
Email address
na_tahan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effect of visual restriction exercise and proprioception exercise in balance of stroke patients.
Public title
The effect of visual restriction exercise on balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients had experienced stroke at least 6 months ago Patients who could perform independent standing no cognitive problems
Exclusion criteria:
Unwillingness to participate to the study Inability to exercise Any orthopedic deformity in lower exteremity Previous stroke
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The random sequence will be performed using the simple randomization. The random number table is used to perform the simple randomization. Allocation concealment is performed using Sequentially numbered, sealed, opaque envelopes To execute the random allocation process, the person involved in randomization is separated from the investigator to reduce possible bias
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid behehsti university of medical sciences
Street address
No.15, Yaman St, Arabi St, Next to Taleghani Hospital, Chamran High way,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.819

Health conditions studied

1

Description of health condition studied
cerebro vascular disease
ICD-10 code
I63.50
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebral artery

Primary outcomes

1

Description
Timed Up-and-Go Test score, Five Times Sit-to-Stand test
Timepoint
Before and after intervention
Method of measurement
Timed Up and Go test

Secondary outcomes

1

Description
Quality of life score
Timepoint
Before and after training
Method of measurement
Questionare

Intervention groups

1

Description
Subjects in the intervention group 1 will perform a general physical therapy exercise(including muscle stretching and strengthening exercise) and balance training exercise on a stable surface (floor) with their eyes close. The intervention will be done for a period of 4 weeks, 3 days a week, with a total of 10 sessions. Each session will be at least 30 minutes .
Category
Rehabilitation

2

Description
Intervention group 2 group will receive a general physical therapy exercise and balance training exercise on an unstable surface. The training will be done for a period of 4 weeks, 3 days a week, with a total of 10 sessions. Each session will be at least 30 minutes.
Category
Rehabilitation

3

Description
Control group only perform a general physical therapy program for a period of 4 weeks, 3 days a week, with a total of 10 sessions. Each session will be at least 30 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabasom rehabilitation center
Full name of responsible person
Nahid Tahan
Street address
No.26, West Baqerkhan st, Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5345
Email
tnpt2378@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
No.15, Yaman St, Arabi St, Next to Taleghani Hospital, Chamran High way
City
Tehran
Province
Tehran
Postal code
985717443
Phone
+98 21 23781
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Tahan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No 152, kamali St, Makhsoos St, South Karegar Ave, Loghman Hakim hospital
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5345
Email
na_tahan@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Tahan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Loghman Hakim Hospital, South Karegar Ave., Makhsoos St., Qazvin St.
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5345
Email
na_tahan@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Tahan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Loghman Hakim Hospital, South Karegar Ave., Makhsoos St., Qazvin St.
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5345
Email
tnpt2378@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No additional informations
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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