Protocol summary
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Study aim
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The effect of exercise therapy on the balance of patients after the acute phase of stroke through remote rehabilitation with a group of patients receiving rehabilitation treatment without the therapist's supervision;Be compared.
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Design
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This study is a randomized clinical trial with parallel groups;The study population was 30 patients referred to Firoozgar and rasoul akram Physical Medicine and Rehabilitation Clinic.
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Settings and conduct
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30 patients referred to the physical medicine and rehabilitation wards of Rasoul Akram and Firoozgar hospitals who have passed the acute phase after stroke and are eligible for the study are randomly divided into two groups of 15 patients And in a group of patients in the first session of the visit receive a training pamphlet of exercise exercises. Patient evaluation is done at the beginning of the study and at the end of the intervention and after one month and three months after the end of the sessions.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with ischemic or hemorrhagic stroke who have hemiplegia and at least one month has passed since the stroke. Balance and gait of the injured patient and exclusion criteria: bilateral paralysis;Imbalance due to injury to the cerebellum or brainstem; Proprioception impairment of vestibular dysfunction; Neurological diseases other than stroke such as neuropathy and any underlying disease that prevents activity
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Intervention groups
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In the experimental group: they receive an educational video of sports exercises through a virtual communication network and then perform the exercises under the therapist's supervision via video call.Control group: Patients in the first session of the visit received a training pamphlet of sports exercises and they are asked to do the exercises at home.
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Main outcome variables
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Berg Balance Scale-time up and go-falls efficacy scale
General information
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Reason for update
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I made a mistake in entering the start date of sampling. I want to replace it and confirm the actual sampling date.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201204049596N1
Registration date:
2020-12-25, 1399/10/05
Registration timing:
prospective
Last update:
2022-06-05, 1401/03/15
Update count:
1
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Registration date
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2020-12-25, 1399/10/05
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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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2021-01-04, 1399/10/15
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Expected recruitment end date
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2022-02-28, 1400/12/09
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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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The effect of exercise therapy on the balance of patients after the acute phase of stroke through Telerehabilitation
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Public title
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The effect of exercise therapy on the balance of patients after the acute phase of stroke through Telerehabilitation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with ischemic or hemorrhagic stroke who have hemiplegia.
Evidence of brain damage by MRI or CTscan
At least one month has passed since the stroke.
Ability to execute a 3-step command
Impaired balance and gait of the patient
Be able to walk with or without support: and be in FAC II - IV.
High-speed Internet access and telephony programs
The presence of a knowledgeable family member next to the patient in all exercise sessions and distance conversation
Exclusion criteria:
Bilateral paralysis
Injury to the cerebellum or brain stem
Proprioception injury
Unilateral hemianopsy / forgetfulness or any other visual impairment
Vestibular dysfunction
Neurological diseases other than stroke such as neuropathy
Severe postural instability
Orthopedic problems
Significant cognitive problems
Perceptual aphasia
Underlying diseases that prevent exercise, such as cardiovascular disease
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Age
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No age limit
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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:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: block
Randomization unit: individual
Randomization tool: Random number table
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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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2020-10-23, 1399/08/02
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Ethics committee reference number
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IR.IUMS.FMD.REC.1399.434
Health conditions studied
1
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Description of health condition studied
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Ataxia following cerebral infarction
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ICD-10 code
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I69.393
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ICD-10 code description
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Ataxia following cerebral infarction
Primary outcomes
1
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Description
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BERG balance scale
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Timepoint
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Before the intervention - after the end of the intervention - one month and three months after the end of the sessions
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Method of measurement
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BERG balance scale questionnaire
2
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Description
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Timed up and Go test
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Timepoint
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Before the intervention - after the end of the intervention - one month and three months after the end of the sessions
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Method of measurement
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Stopwatch
3
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Description
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Fall efficiency scale
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Timepoint
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Before the intervention - after the end of the intervention - one month and three months after the end of the sessions
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Method of measurement
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Persian questionnaire of falling efficiency scale
Intervention groups
1
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Description
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Intervention group: The educational video of the exercise program for the patient is sent in the first absentee communication and through the virtual network. It should be used in the treatment sessions.And the therapist ensures the proper implementation of exercise programs.
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Category
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Rehabilitation
2
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Description
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Control group: In the first session of the visit, an educational pamphlet is provided to the patient and the patient is taught how to perform the exercises correctly in the same session. The patient is asked to perform the exercises according to the above program.
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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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No
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Title of funding source
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Iran 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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Yes - There is 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All the patients data can potentially be shared with privacy in regard to patients name
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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The use of documents is allowed only by mentioning the source
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From where data/document is obtainable
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Simin Sajjadi -Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
attari.a@iums.ac.ir -00982182141229
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What processes are involved for a request to access data/document
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First, the identity of the person is verified, then the data is provided to the person
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Comments
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