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Effectiveness of Cognitive Orientation to daily Occupational Performance (CO-OP) on Satisfaction and Occupational Performance in Individuals with Parkinson’s Disease

Protocol summary

Study aim
The Investigation of the Effectiveness of Cognitive Orientation to daily Occupational Performance (CO-OP) on Satisfaction and Occupational Performance in Individuals with Parkinson’s Disease
Design
Clinical, Randomized, Double-blind trial with two parallel groups
Settings and conduct
For both groups, one-hour individual sessions will be held twice a week for 6 weeks at their home. Participants in the control group benefit from conventional occupational therapy. while in the intervention group, the CO-OP approach is implemented. The evaluations will be performed by a trained assessor who is blind to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants with Parkinson’s Disease diagnosed by a neurologist, Hoehn and Yahr scale score between stages 1-3, Minimum score of 16 out of 30 in the Montreal test, No other neurological or psychological problems, No verbal problem, Ability to understand the global strategy of the co-op approach. exclusion criteria: Comorbidity with cognitive impairments such as Alzheimer, stroke, brain injury, multiple sclerosis, etc. Lack of cooperation and willingness to continue cooperation.
Intervention groups
Participants in the intervention group will receive the Cognitive Orientation to daily Occupational Performance (CO-OP) approach and Participants in the control group will receive conventional occupational therapy. This study will be presented in 45 to 60 minutes twice a week for 12 sessions at home.
Main outcome variables
Performance, Satisfaction, Goal Attainment, Functional Independence and fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210901052356N1
Registration date: 2021-09-20, 1400/06/29
Registration timing: registered_while_recruiting

Last update: 2021-09-20, 1400/06/29
Update count: 0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Atefeh Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 8798
Email address
taheri.atefeh.ot@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2021-11-16, 1400/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive Orientation to daily Occupational Performance (CO-OP) on Satisfaction and Occupational Performance in Individuals with Parkinson’s Disease
Public title
Investigating effects of CO-OP approach in Individuals with Parkinson’s Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Parkinson’s Disease by a neurologist Hoehn and Yahr scale score between stages 1-3 A minimum score of 16 out of 30 on the Montreal Test No other neurological or psychological problems Not having a verbal problem And the ability to understand the global strategy of the CO-OP approach
Exclusion criteria:
Comorbidity with cognitive impairments such as: Alzheimer, stroke, brain injury, multiple sclerosis, etc. Lack of cooperation and willingness to continue cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will select by convenience sampling. we use simple randomization for allocation of samples into the control and CO-OP group. For this purpose, before starting the intervention, through the site randomization.com, according to the sample size, a sequence of placing participants in two groups ( both are equal) is created. After the start of the study, each participant who was eligible to enter the study will receive a control or co-op intervention from a pre-prepared sequence list.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be aware of the group that they are entered. The assessments will be performed by participants and trained assessor who are blind to the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Tehran university of medical sciences, school of rehabilitation, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2020-02-12, 1398/11/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.177

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Performance and satisfaction scores of client-chosen goal
Timepoint
pretest , post test and follow-up (one months after last session)
Method of measurement
Canadian Occupational Performance Measurement (COPM)

Secondary outcomes

1

Description
Goal Attainment
Timepoint
Pretest, post test and follow-up
Method of measurement
Goal Attainment Scale (GAS)

2

Description
Activities of Daily Living
Timepoint
Pretest, post test and follow-up
Method of measurement
Functional Independence Measure (FIM)

3

Description
Fatigue
Timepoint
Pretest, post test and follow-up
Method of measurement
Parkinson Fatigue Scale (PFS)

Intervention groups

1

Description
Intervention group: The intervention group receives the CO-OP approach in 12 sessions of 45-60 minutes and 2 sessions per week. This approach has a specific protocol. The first stage is preparation phase. In this stage, the necessary prerequisites for this approach are checked in the clients and also the purpose of treatment is given to the clients. The first session will be after the preparation phase and is evaluation session. In this session, participants select three performance goals based on the Canadian occupational performance measure Scale (COPM), And they score satisfaction and performance of three goals based on a ten-point scale. The second session will give the necessary explanations about the global cognitive strategy (Goal-Plan-Do-Check) to the clients, the focus of this session is on teaching this global strategy. Sessions three to eleven people acquire skills using these strategies, in these sessions the focus is on learning skills, in these sessions, dynamic performance analysis, guided discovery and the Enabling principles are used continuously, and session twelve Assessments are also performed again.
Category
Rehabilitation

2

Description
Control group: Patients in the control group received conventional occupational therapy. Evidence suggests that these interventions often include stretching and strengthening exercises, improving postural control, improving balance, relaxation techniques, breathing exercises, and gait training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
DR. Hamid Dalvand
Street address
iaeian Hospital, opposite the municipality of the region 17, Abouzar Street, Tehran,
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6813
Email
ziaeian@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyedeh Tahmineh Mousavi
Street address
Tehran University of Medical Sciences, school of rehabilitation, Enghelab street, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Atefeh Taheri
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Tehran University of Medical Sciences - School of Rehabilitation, Enghelab St, Pich-e-Shemiran.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 913 577 7223
Email
Taheri.atefeh.ot@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyedeh tahmineh mousavi
Position
Ph.D. of Occupational Therapy, Assistant Professor, Department of Occupational Therapy, School of Re
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Tehran University of Medical Sciences, School of Rehabilitation, Occupational Therapy department, Enghelab street, Piche-shemiran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 4133
Email
t.mousavi@alumni.ubc.ca

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefeh Taheri
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Tehran University of Medical Sciences - School of Rehabilitation, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 913 577 7223
Email
Taheri.atefeh.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
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
Article
When the data will become available and for how long
March 2022
To whom data/document is available
The researcher and occupational therapists
Under which criteria data/document could be used
Other research, critics, check and clinical usage
From where data/document is obtainable
Tehran university of Medical Science, School of Rehabilitation Sciences, Occupational Therapy department
What processes are involved for a request to access data/document
The data and results of the study are available in the final version and are available at the Faculty of Rehabilitation.
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