Comparing effects of Cognitive Orientation to daily Occupational Performance (CO-OP) approach and exercise training on participation, and fatigue in people with Multiple Sclerosis
The aim of this study was to compare the effect of Cognitive Orientation to daily Occupational performance (CO-OP) approach on the participation of people with multiple sclerosis in daily life activities (their performance and satisfaction), participation in social activities and their degree and severity of fatigue with exercise-based therapies.
Design
The present study is a parallel single-blind randomized clinical trial designed as a pretest-posttest. The predicted sample size is 30 people (15 people in each group). A random sequence created by randomization.com will be used for randomization.
Settings and conduct
Participants in the treatment group receive a CO-OP approach. One-hour individual sessions will be held twice a week for 5 weeks at home. Participants in the control group will receive stretching exercises, strengthening exercises and balance exercises for 5 weeks, 3 sessions per week and a total of 15 sessions of 45 minutes. These exercises will be performed in the clinic. Because the participants are not related to each other, they are blinded.
Participants/Inclusion and exclusion criteria
Participants are people with multiple sclerosis diagnosed by a neurologist, aged 18-50, with an EDSS score between 3-5.5, and score ,ore than 26 in MoCA . People who have a history of CO-OP treatment or similar treatments or who have neurological, rheumatic, or orthopedic disorders that interfere with treatment will not be included in the study.
Intervention groups
The intervention group includes people with multiple sclerosis with an EDSS score of 3 to 5.5 who receive a Cognitive Orientation to daily Occupational performance (CO-OP) approach. The control group includes people with multiple sclerosis with an EDSS score of 3 to 5.5 who receive exercise therapy intervention.
Main outcome variables
Participation in activity of daily living and social. fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210621051643N1
Registration date:2021-06-22, 1400/04/01
Registration timing:prospective
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Mehrdad Saeidi Borujeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
ms.borujeni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of Cognitive Orientation to daily Occupational Performance (CO-OP) approach and exercise training on participation, and fatigue in people with Multiple Sclerosis
Public title
Investigating effects of CO-OP approach on people with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of multiple sclerosis by a neurologist
Age between 18-50 years
EDSS score between 3 and 5.5
Score more than 26 in the MoCA assessment
Exclusion criteria:
Recurrence of symptoms or the onset of a new attack during the intervention period
History of receiving CO-OP treatment or similar treatments
Existence of neurological, rheumatic or orthopedic disorders that interfere with treatment
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
we use simple sampling method and simple randomization for allocation of samples into the two group in the present study. For this purpose, before starting the study, a sequence of letters a and b (so that both are equal) is created through randomization.com, according to the sample size. After the start of the study, each participant who met the entry requirements will receive a number based on the time of entry into the study and will receive intervention a or b from a pre-prepared sequence list.
Blinding (investigator's opinion)
Single blinded
Blinding description
The people in charge of the initial and final evaluations as well as the people in charge of data analysis are not aware of the category of participants. Depending on the nature of the study, researchers and participants will be aware of the type of categorization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َUniversity Social welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2020-06-22, 1399/04/02
Ethics committee reference number
IR.USWR.REC.1399.087
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Participation and Satisfaction in Activity of Daily Living (ADL)
Timepoint
Before the intervention ,After the intervention, follow-up period of 3 months
Method of measurement
Canadian Occupational Performance Measure (COPM)
Secondary outcomes
1
Description
Depression score
Timepoint
Before intervention, after intervention, 3-month follow-up period
Method of measurement
Beck Depression Inventory II (BDI-II)
2
Description
Quality of life score
Timepoint
Before intervention, after intervention, 3-month follow-up period
Method of measurement
Multiple Sclerosis Impact Scale (MSIS-29)
3
Description
Social participation
Timepoint
Before intervention, after intervention, 3-month follow-up period
Method of measurement
Community Integration Questionnaire (CIQ)
4
Description
Intensity and effect of fatigue
Timepoint
Before intervention, after intervention, 3-month follow-up period
Intervention group: The CO-OP approach is implemented in 10 sessions. In the first session, performance goals are determined by the authorities using the COPM questionnaire. The therapist then teaches the general problem-solving strategies (goal, plan, execution, check) and how to use field-specific strategies to design and execute the plan and achieve the intended goal. Then, for example, an experimental goal is selected and the general and specific strategies of the field for that goal are practiced with the authorities. From the third session onwards, work on the selected goals of the clients begins. The client plans for its own purposes. The therapist, as an active observer, guides the client through guided discovery, if, given his or her expertise, the program is likely to pose a risk to the client or contain items that make it impossible to reach the target. Guides. Upon entering the program implementation section, dynamic activity analysis is performed by the therapist to identify the needs and obstacles of program implementation at each stage and eliminate them using field-specific cognitive strategies.
Category
Rehabilitation
2
Description
Control group: Participants in the control group will receive stretching exercises, strengthening exercises and balance exercises for 6 weeks, 3 sessions per week and a total of 18 sessions of 45 minutes. These exercises will be performed in the clinic. At the discretion of experts, the type of exercise and the duration and intensity of each exercise may vary according to the circumstances of each client.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran MS Society, Sina hospital
Full name of responsible person
Mehrdad Saeidi Borujeni
Street address
Imam Khomeini St., Hassan Abad Sq. , Sina Hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
ms.borujeni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Professor Hamidreza Khorram Khorshid
Street address
Kudakyar Alley, Daneshju Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Web page address
https://researchdeputy-en.uswr.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Seyed Ali Hosseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
alihosse@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
City
Tehran
Province
Tehran
Postal code
1985713831
Phone
+98 21 2218 0037
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
Mehrdad Saeidi Borujeni
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713831
Phone
+98 21 2218 0037
Email
ms.borujeni@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Since the all rights of this study are at the disposal of the University of Social Welfare and Rehabilitation Sciences, any decision regarding the publication of data is at the disposal of this university.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available