A randomized controlled trial to comparative study of the effect of single and dual cognitive task-oriented balance exercises on postural control and functional balance in subjects with chronic stroke
The aim of this study is to comparative study of the effect of single and dual cognitive task-oriented balance exercises on postural control, functional balance and mobility and cognitive function in subjects with chronic stroke.
Design
This study is a controlled randomized trial with parallel groups and blinded outcome assessment. Fifty-four chronic stroke survivors will participate in this study and they will be randomly assigned to three groups: control group, single task-oriented balance exercises group and cognitive dual task-oriented balance exercises group. Randomization will be performed by the person who is not involved in the study using sequentially numbered sealed envelopes.
Settings and conduct
This study will be performed in Djavad Mowafaghian Research Centre of Intelligent Neuro-Rehabilitation Technologies. Control group receives conventional rehabilitation. Single and cognitive dual task-oriented balance exercises groups receive 24 sessions of task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to conventional rehabilitation. In single task-oriented balance exercises group, the attention of patient will be focused on maintaining his/her balance while in the cognitive dual task-oriented balance exercises group, the attention of patient will be focused on maintaining his/her balance while in the cognitive dual task-oriented balance exercises group, the attention of patient will be focused concurrently on maintaining balance and performing cognitive tasks. Assessment of the primary and secondary outcomes is performed by individuals who are blinded to the groups allocation before and after receiving task-oriented balance exercises and 8 weeks after receiving these exercises in the intervention groups and before and after conventional rehabilitation and 8 weeks after conventional rehabilitation in the control group.
Participants/Inclusion and exclusion criteria
The main inclusion criteria include having the first experience of stroke; Having the ability to perform the most difficult condition of laboratory test (quiet standing on foam surface with closed eyes while performing cognitive task); Having an acceptable level of cognitive function, i.e. score equal to or greater than 23 on the Mini Mental State Examination. Subjects are excluded in the case of having unilateral visuospatial neglect and co-morbid other neurological diseases, orthopedic disorders, diabetes or addiction.
Intervention groups
Control group; Single task-oriented balance exercise; Cognitive dual task-oriented balance exercise
Main outcome variables
Functional balance; Postural control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140304016830N9
Registration date:2018-02-25, 1396/12/06
Registration timing:registered_while_recruiting
Last update:2018-02-25, 1396/12/06
Update count:0
Registration date
2018-02-25, 1396/12/06
Registrant information
Name
Ghorban Taghizadeh
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
taghizadeh.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial to comparative study of the effect of single and dual cognitive task-oriented balance exercises on postural control and functional balance in subjects with chronic stroke
Public title
Effect of task-oriented balance exercises on balance of patients with chronic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the first experience of stroke
Passing 6-24 months since stroke
Having an ability to walk at least 10 meters without assistive devices
Having the ability to perform the most difficult condition of laboratory test (quiet standing on foam surface with closed eyes while performing cognitive task)
Having an acceptable level of cognitive function, i.e. score equal to or greater than 23 on the Mini Mental State Examination
Exclusion criteria:
Having unilateral visuospatial neglect (i.e., obtaining score less than 44 at star cancellation test)
Co-morbid other neurological diseases
Having orthopedic disorders (such as low back pain, arthritis and flat foot)
Having diabetes according to the report of patient, or the patient's family or physician
Having addiction according to the report of patient, or the patient's family or physician
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by the person who is not involved in the study using sequentially numberd sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation.
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
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-08, 1396/09/17
Ethics committee reference number
IR.IUMS.REC 1396.30275
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Functional balance
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Berg Balance Scale Questionnaire, Tinetti Balance test
2
Description
Postural control
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Force plate (postural sway parameters)
Secondary outcomes
1
Description
Functional mobility
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Single and dual Timed Up & Go Test, Dynamic gait index Questionnaire
2
Description
Cognitive function
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Wechsler memory scale
Intervention groups
1
Description
Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living).
Category
Rehabilitation
2
Description
First intervention group: ُSingle task-oriented balance exercises group that receives 24 sessions of single task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to the conventional rehabilitation. Single task-oriented balance exercises include three types of standing, transferring and walking activities which performed based on two principals of difficulty level of motor task and individual safety.
Category
Rehabilitation
3
Description
Second Intervention group: cognitive dual task-oriented balance exercises group that receives 24 sessions of cognitive dual task-oriented balance exercises (8 weeks, 3 sessions per week, 60 to 90 minutes per session) in addition to the conventional rehabilitation. In this group, task-oriented balance exercises (including three types of standing, transferring and walking activities based on two principals of difficulty level of motor task and individual safety) are performed simultaneously with cognitive tasks (e.g., backward counting, saying the days of the week and the months of the year in reverse order, etc.).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation centers and hospitals in Tehran
Full name of responsible person
Ghorban Taghizadeh
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Iran University of Medical Sciences, Dr. Seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Ghorban Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published. If more details are needed, individuals can send their request by email to the person responsible for scientific accountability.
When the data will become available and for how long
8 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of the documentation is permitted upon written permission.
From where data/document is obtainable
Ghorban Taghizadeh
Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tel: 00982122227124
E-mail: taghizadeh.gh@iums.ac.ir
What processes are involved for a request to access data/document
Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.