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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Berg Balance Scale-time up and go-falls efficacy scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201204049596N1
Registration date:2020-12-25, 1399/10/05
Registration timing:registered_while_recruiting
Last update:2020-12-25, 1399/10/05
Update count:1
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Arezoo Attari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8893 3835
Email address
attari.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-29, 1399/09/09
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise therapy on the balance of patients after the acute phase of stroke through Telerehabilitation
Public title
The effect of exercise therapy on the balance of patients after the acute phase of stroke through Telerehabilitation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block
Randomization unit: individual
Randomization tool: Random number table
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 Iran University of Medical Sciences
Street address
School of Medicine , Iran University of Medical Sciences , Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614555
Approval date
2020-10-23, 1399/08/02
Ethics committee reference number
IR.IUMS.FMD.REC.1399.434
Health conditions studied
1
Description of health condition studied
Ataxia following cerebral infarction
ICD-10 code
I69.393
ICD-10 code description
Ataxia following cerebral infarction
Primary outcomes
1
Description
BERG balance scale
Timepoint
Before the intervention - after the end of the intervention - one month and three months after the end of the sessions
Method of measurement
BERG balance scale questionnaire
2
Description
Timed up and Go test
Timepoint
Before the intervention - after the end of the intervention - one month and three months after the end of the sessions
Method of measurement
Stopwatch
3
Description
Fall efficiency scale
Timepoint
Before the intervention - after the end of the intervention - one month and three months after the end of the sessions
Method of measurement
Persian questionnaire of falling efficiency scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation, Firoozgar hospital, Tehran
Full name of responsible person
Ghulam Reza Raisi
Street address
Firoozgar Hospital , Be Afarin Street ; Vali Asr Square;
City
Tehran
Province
Tehran
Postal code
1593749999
Phone
+98 21 8214 1229
Email
attari.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
5th floor, Headquarters , Iran University of Medical Sciences , Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614555
Phone
+98 21 8214 1229
Email
attari.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Simin Sajjadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation ,Firoozgar Hospital , Vali Asr Square l
City
Tehran
Province
Tehran
Postal code
1449614555
Phone
+98 21 8214 1229
Email
attari.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Simin Sajjadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation , Firoozgar Hospital , Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1449614555
Phone
+98 21 8214 1229
Email
attari.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Simin Sajjadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation , Firoozgar Hospital , Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1449614555
Phone
+98 21 8214 1229
Email
attari.a@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the patients data can potentially be shared with privacy in regard to patients name
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of documents is allowed only by mentioning the source
From where data/document is obtainable
Simin Sajjadi -Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
attari.a@iums.ac.ir -00982182141229
What processes are involved for a request to access data/document
First, the identity of the person is verified, then the data is provided to the person