Protocol summary

Study aim
- Comparison of the effect of "Cognitive Orientation to Daily Occupational Performance" and "motivational interviewing" on the functional independence of chronic stroke patients in performing activities of daily living. 2- Comparing the effect of "Cognitive Orientation to Daily Occupational Performance" and "motivational interviewing" on the occupational performance of chronic stroke patients. 3- Comparing the effect of "Cognitive Orientation to Daily Occupational Performance" and "motivational interviewing" on self-efficacy of chronic stroke patients.
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 60 stroke patients. Randomization is done using the block random allocation using the website www.sealedenvelope.com.
Settings and conduct
Patients who are eligible to enter are referred to a private clinic. After obtaining the written consent, the evaluations will be done by an evaluator who is unaware of the allocation. people will be randomly placed in each of the three groups. The intervention in all three control groups will be CO-OP and MI two sessions per week for five weeks for chronic stroke patients. ​
Participants/Inclusion and exclusion criteria
Inclusion criteria: A volunteer to enter the study, chronic ischemic stroke, over 18 years old, sufficient cognitive ability, the lowest level of depression or mild depression to moderate depression, being in stage 3 or higher of Brunnstrom, no disorder in verbal comprehension. Exclusion criteria: non-cooperation of the patient during the intervention or unwillingness to continue cooperation in the intervention, non-follow-up of the patient to participate in at least two treatment sessions, recurrence of stroke
Intervention groups
1-Control Group 2- Cognitive Orientation to Daily Occupational Performance (CO-OP) 3- Motivational Interviewing (MI)
Main outcome variables
Occupational Performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180515039676N1
Registration date: 2023-12-11, 1402/09/20
Registration timing: prospective

Last update: 2023-12-11, 1402/09/20
Update count: 0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Shiva Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0063
Email address
shiva.abedi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of “Cognitive Orientation to Daily Occupational Performance” (CO-OP) with “Motivational Interviewing” (MI) on occupational performance in chronic stroke patients: a randomized controlled trial
Public title
"Comparing Cognitive Orientation to Daily Occupational Performance with Motivational Interviewing on occupational performance in stroke patients"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be a volunteer to enter the study (completion of the consent form) Chronic ischemic stroke (at least one year has passed since the stroke) diagnosed by a neurologist. Age 18 years and above Sufficient cognitive ability (minimum score of 22 on the Montreal Cognitive Test) Scores 5-18 in the Beck Depression Questionnaire (short form) (minimum level of depression or mild depression to moderate depression) Being in stage 3 and above Brunnstrom Absence of disorder in verbal understanding such as Wernicke's and Global aphasia.
Exclusion criteria:
Patient's non-cooperation during the intervention or unwillingness to continue cooperation in the intervention2- Failure to follow up the patient to participate in at least two treatment sessions3- Reoccurrence of stroke
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block random allocation method is used for data allocation. This allocation is done in several steps. First, using the website www.sealedenvelope.com, a random sequence with blocks of six is created. Then, to hide the random allocation, sealed and waxed opaque envelopes are used in a random sequence. Based on the size of the research sample, a number of envelopes with aluminum wrapping (in view of the lack of clarity of the contents of the envelopes), preparation and each of the random sequences created on a card are recorded and the cards inside the envelopes are called They are placed in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of registration of the participants, according to the order of entry of the eligible participants to the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
This will be a single-blind study. It should be noted that all evaluations are done by a trained evaluator therapist who does not know about the allocation of people in each of the groups, which is different from the examiner who performs the intervention in three groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
IR.USWR.REC.1402.122

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as hemorrhage or infarction

Primary outcomes

1

Description
occupational performance
Timepoint
Before the intervention, five weeks and one month after the intervention
Method of measurement
Canadian Occupational Performance Measure Scale (COPM), Performance Quality Rating Scale (PQRS)

Secondary outcomes

1

Description
Self-efficacy
Timepoint
Before the intervention, five weeks and one month after the intervention
Method of measurement
General Self-Efficacy Scale (GSE-10)

2

Description
Independence in daily activities of life
Timepoint
Before the intervention, five weeks and one month after the intervention
Method of measurement
Functional Independence Measurement (FIM)

Intervention groups

1

Description
Intervention group: Cognitive Orientation to Daily Occupational Performance (CO-OP)
Category
Rehabilitation

2

Description
Intervention group: Motivational Interviewing (MI)
Category
Rehabilitation

3

Description
Control group: Usual treatment (occupational therapy)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Medical and Education Center
Full name of responsible person
Shiva Abedi
Street address
AgharebParast Highway.,Sofe Blvd ., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/en

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nazila Akbarfahimi
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran Town
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Fax
Email
fahimi1970@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Social Welfare and Rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Shiva Abedi
Position
PhD Student in Ocuupational Therapy
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Bagh Goldaste Ave., Goldis Center, Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8145613353
Phone
+98 31 3224 5327
Email
shiva.abedi.ot@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nazila Akbarfahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin., Tehran Town
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
fahimi1970@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Shiva Abedi
Position
PhD student in Occupational Therapy
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Bagh Goldasteh., Goldis Center., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8145613353
Phone
+98 31 3224 5327
Email
shiva.abedi.ot@gmail.com

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
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions and rehabilitation professionals in clinical settings.
Under which criteria data/document could be used
Providing the medical system card to ensure the clinical competence of people to provide services.
From where data/document is obtainable
Sending an email to an address named Shiva Abedi, sending an SMS to the contact number of Shiva Abedi, making a call to the number of Shiva Abedi, visiting in person Dr. Nazila Akbarfahimi at the University of Social Welfare and Rehabilitation Sciences.
What processes are involved for a request to access data/document
First, the applicant must send a request to receive the documents to an email address named Shiva Abedi, if there is no response after 10 days, send an SMS or call the contact number of Shiva Abedi, then the responsible person ( Abedi) makes the necessary arrangements to send the documents to the applicant. If the responsible person (Abedi) did not respond within 7 days after sending the text message and making the call, the requesting person can send his request to the email address of Dr. Nazila Akbarfahimi.
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