A randomized controlled trial to compare the effect of occupation-based interventions with and without motivational strategies on functional balance, postural control and participation in activities of daily living in people with chronic stroke
The aim of this study is to compare the of occupation-based interventions with and without motivational strategies on postural control and participation in activities of daily living in people with chronic stroke.
Design
This study is a double-blinded controlled randomized trial with parallel groups. Forty-eight chronic stroke survivors will participate in this study and they will be randomly assigned to three groups. Randomization will be performed by the person who is not involved in the study using sealed envelopes method.
Settings and conduct
This study will be performed in Djavad Mowafaghian of Neuro-Rehabilitation Research Center. Control group receives conventional rehabilitation. Occupation-based intervention groups receive 12 sessions interventions (6 weeks, 2 sessions per week, 75 minutes per session) in addition to conventional rehabilitation. In occupation-based interventions with motivational strategies group, different motivational strategies will be used to enhance an individual's level of motivation. Assessors and patients are blinded to the groups allocation.
Participants/Inclusion and exclusion criteria
In this clinical trial study, 48 subjects with chronic stroke will participate. The main inclusion criteria include having the first experience of stroke, passing at least 6 months since stroke, and 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; Occupation-based interventions with motivational strategies group; Occupation-based interventions without motivational strategies group
Main outcome variables
Postural control; functional balance; Participation in activities of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140304016830N10
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Ghorban Taghizadeh
Name of organization / entity
School 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
2019-06-22, 1398/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial to compare the effect of occupation-based interventions with and without motivational strategies on functional balance, postural control and participation in activities of daily living in people with chronic stroke
Public title
The effect of occupational therapy interventions on balance and participation in activities of daily living in people with chronic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the first experience of stroke
Passing at least 6 months since stroke
Ability to walk at least 10 meters with or without assistive device
Ability to stand for at least 5 minutes on the foam surface
Having an acceptable level of cognitive function, i.e. score equal to or greater than 23 on the Persian version of Mini Mental State Examination
Feeling the need or desire to participate in occupations selected for the intervention
Exclusion criteria:
Having unilateral visuospatial neglect (i.e., obtaining score less than 44 at star cancellation test)
Co-morbid other neurological diseases, orthopedic disorders (such as low back pain and arthritis), diabetes or addiction according to the report of the patient, or patient's family or physician
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by the person who is not involved in the study using sealed envelopes method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation. Patients are also blind to the type of intervention they receive.
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
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1398.002
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
Postural control parameters (including velocity and amplitude of center of pressure sways recorded by force plate)
Timepoint
Before and after intervention and 6 weeks after intervention
Method of measurement
Force plate
2
Description
Functional balance
Timepoint
Before and after intervention and 6 weeks after intervention
Method of measurement
Timed Up and Go test, Berg balance scale
3
Description
Level of participation in activities of daily living
Timepoint
Before and after intervention and 6 weeks after intervention
Method of measurement
Canadian occupational performance measure, Meaningful Activity Participation Assessment Questionnaire
Secondary outcomes
empty
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: Occupation-based interventions with motivational strategies group that receives 12 sessions of intervention including different occupations with emphasize on motor learning approach (6 weeks, 2 sessions per week, 75 minutes per session) in addition to the conventional rehabilitation. In this group, different motivational strategies will be used to enhance an individual's level of motivation during the intervention.
Category
Rehabilitation
3
Description
Second Intervention group: Occupation-based interventions without motivational strategies group that receives 12 sessions of intervention including different occupations with emphasize on motor learning approach (6 weeks, 2 sessions per week, 75 minutes per session) in addition to the conventional rehabilitation. In this group, motivational strategies will not be used during the intervention.
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 Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian.a@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
One year 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, Tehranو Tel: 00982122227124و 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.