Protocol summary
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Study aim
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To compare effects of balance training on an unstable surface with balance training under visual deprivation conditions in persons with stroke
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Design
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A randomized, placebo-controlled clinical trial, parallel group trial with blinded outcome assessor and data analyzer .
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Impossibility of sampling due to corona virus.
The start date of sampling will be corrected on 02/20/1991.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190812044516N1
Registration date:
2020-04-15, 1399/01/27
Registration timing:
prospective
Last update:
2020-05-17, 1399/02/28
Update count:
2
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Registration date
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2020-04-15, 1399/01/27
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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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2020-05-09, 1399/02/20
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Expected recruitment end date
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2020-07-10, 1399/04/20
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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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To compare the effect of visual restriction exercise and proprioception exercise in balance of stroke patients.
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Public title
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The effect of visual restriction exercise on balance
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 50 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2020-02-24, 1398/12/05
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1398.819
Health conditions studied
1
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Description of health condition studied
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cerebro vascular disease
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ICD-10 code
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I63.50
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ICD-10 code description
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Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebral artery
Primary outcomes
1
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Description
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Timed Up-and-Go Test score, Five Times Sit-to-Stand test
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Timepoint
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Before and after intervention
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Method of measurement
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Timed Up and Go test
Secondary outcomes
1
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Description
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Quality of life score
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Timepoint
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Before and after training
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Method of measurement
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Questionare
Intervention groups
1
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Description
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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 .
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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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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Shahid Beheshti 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No additional informations
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not 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