The aim of this study is to investigate the efficacy of meaningful action observation on occupational performance and brain physiological changes of chronic stroke patients.
Design
A single randomized clinical trial, with a parallel group of 15 patients
Settings and conduct
The location of the study is Firoozagar Hospital and assessor has been blinded before and after the interventions in two groups.
Participants/Inclusion and exclusion criteria
Inclusion:
History of Only one cerebrovascular accident
A score of +21 in Mini-mental state examination
+6 months post since a stroke in Medial cerebral artery
Motor recovery stage 3 to 5 in Brunnstrom's test
No visual impairment due to the ability to watch and precept a video film
No disease comorbidity that interferes with the study
Independent walking ability with or without an assistive device
Ability to sit independently at least for 1 hour
ٍExclusion:
Implant or prosthesis in the skull
Lack of cooperation in the evaluation sessions
Intervention groups
In the Intervention group After selecting tasks from some predefined tasks, for about 30 minutes, the participant should watch a video film of a standard performance of the selected task by a model and then execute the viewed task while the affected hand has the main role in that performance. At the beginning of each session, preparatory techniques for the upper extremity including stretching, weight bearing, and active/passive exercise will be performed about 10 minutes.
In the control group also the selected task will be performed with this difference that the participant will just watch a video film of static pictures and/or landscapes without a creator being. At the beginning of each session, preparatory techniques for the upper extremity including stretching, weight bearing, and active/passive exercise will be performed about 10 minutes.
Main outcome variables
Occupational Performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029260N2
Registration date:2019-03-08, 1397/12/17
Registration timing:prospective
Last update:2019-03-08, 1397/12/17
Update count:0
Registration date
2019-03-08, 1397/12/17
Registrant information
Name
Afsson Hassani Mehraban
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22227124
Email address
mehraban.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of meaningful Action Observation on occupational performance and brain physiological changes in chronic stroke patients
Public title
The effects of action observation on chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of Only one cerebrovascular accident
At least a score of 21 in Mini-mental state examination(MMSE)
At least 6 months post since stroke in Medial cerebral artery(Neurologist diagnosis)
Motor recovery stage 3 to 5 in Brunnstrum`s test
No visual impairment due to ability to watch and precept a video film(Optometrist verification)
No disease comorbidity that interfere with the study
Independent walking ability with or without assistive device
Ability to sit independently at least for 1 hour
Exclusion criteria:
A recurrent stroke
Implant or prosthesis in the skull
Lack of cooperation in the evaluation sessions
Participation in other therapeutic programs
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Block: In this method, the number of participants is assigned to each group are the same and the size of all blocks is equal (for example, in a double-blind trial, 8 blocks are containing 4 participants in the intervention group and 4 participants in the control group)
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The person or people who evaluate the outcome or non-outcome of the outcome in the participants or collect data on the outcome variables.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Iran University of Medical Sciences
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Approval date
2019-01-17, 1397/10/27
Ethics committee reference number
IR.IUMS.REC.1397.840
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67
ICD-10 code description
Other cerebrovascular diseases
Primary outcomes
1
Description
Occupational Performance
Timepoint
first, final, one month after intervention
Method of measurement
Canadian Occupational Performance Measure
Secondary outcomes
1
Description
Physiologic Changes of the brain
Timepoint
Before and after the intervention
Method of measurement
Motor evoked potential
Intervention groups
1
Description
Intervention group: After selecting tasks from some pre defined tasks, for about 30 minutes participant should watch a video film of standard performance of the selected task by a model and then execute the viewed task while the affect hand has the main role in the task performance. In beginning of each session preparatory techniques for the upper extremity including stretching, weight bearing, and active/passive exercise will be performed about 10 minutes.
Category
Rehabilitation
2
Description
Control group: In the control group also the selected task will be performed with this difference that the participant will just watch a video film of static pictures and/or landscapes without a creator being. In beginning of each session preparatory techniques for the upper extremity including stretching, weight bearing, and active/passive exercise will be performed about 10 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Aryan Shamili
Street address
Karim khan-Beh afarin
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Email
Shamilia@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakoti
Street address
Hemmat highway
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
Shamilia@tbzmed.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
Afsoon hassani mehraban
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad
City
tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
Mehraban.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsoon Hassani Mehraban
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
mirdamad
City
tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
mehraban.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aryan Shamili
Position
Phd Candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad
City
tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
shamilia@tbzmed.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document