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Comparison of the effectiveness of occupation-based practice and exercise training on upper extremity function of people with Multiple Sclerosis

Protocol summary

Study aim
Comparison of the effect of occupation-based intervention with exercise-based intervention on occupational performance, satisfaction of occupational performance, hand dexterity, muscle tone and fatigue of patients with multiple sclerosis
Design
Randomised control trial with control group, with a parallel group design, single blind, randomised controlled trial
Settings and conduct
In this randomized clinical trial, eligible patients will be recruited and randomly assigned to one of two groups. Intervention will take place in Isfahan Multiple sclerosis center. Control group will receive exercise based intervention. Intervention group will receive 12 sessions of occupation-based intervention. After the end of treatment sessions the pretest and post-test scores of the two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having Multiple sclerosis according to neurologist diagnosis, age: 18-50, Expanded Disability Status Scale score between 3 and 5.5, hand performance difficulty Exclusion criteria: History of relapse during the last 6 months, Neurological, rheumatic, musculoskeletal or orthopedic disorders that interfere with treatment.
Intervention groups
Intervention group: Occupation-based intervention involves a type of client-centered therapy in which the client and therapist work together to select meaningful activities based on interests, needs, health and participation in the daily activities of the client then they plan the intervention. Occupation-based intervention will be in one-hour sessions, twice a week for six weeks. Control group: Exercise-based intervention physical activity that is usually performed regularly with the aim of promoting or maintaining physical or health fitness. Treatment will be in one-hour sessions, twice a week for six weeks.
Main outcome variables
dexterity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190809044482N1
Registration date: 2020-05-01, 1399/02/12
Registration timing: retrospective

Last update: 2020-05-01, 1399/02/12
Update count: 0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Sara Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
afsharsara262@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of occupation-based practice and exercise training on upper extremity function of people with Multiple Sclerosis
Public title
Effect of occupation-based practice on upper extremity function of people with Multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with Multiple Sclerosis diagnosed with neurologist Expanded Disability Status Scale score between 3-5.5 Montreal Cognitive Assessment score more than 24 at least one effected hand in Coin Rotation Task and 9 hole peg test age between 18-50
Exclusion criteria:
relapse in the past 6 month patients with other neurologic disorders patients with rheumathologic disorders patients with orthopedic disorders patients with musculoskeletal disorders that have effect on hand mobility
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in the study will be randomly assigned to the intervention or control group. Randomization using GraphPad software provides a string of random codes A (intervention group) and B (control group) completely randomly. This list is provided to the clinic secretary to enter patients into study groups based on their entry into the clinic. Allocation concealment will be performed by the secretary of the multiple sclerosis center.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be aware of the type of intervention, but the evaluator will be someone else who will not be aware of the type of intervention. Therefore, the study will be conducted as a single blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar alley, Daneshjoo bulvar, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-03-15, 1396/12/24
Ethics committee reference number
IR.USWR.REC.1396.319

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
dexterity
Timepoint
before the intervention and 7 weeks after intervention
Method of measurement
Nine Hole Peg Test

Secondary outcomes

1

Description
occupational performance
Timepoint
before intervention and 7 weeks after intervention
Method of measurement
Canadian occupational performance measure

Intervention groups

1

Description
Intervention group: Occupation-based intervention involves a type of client-centered therapy in which the client and therapist work together to select meaningful activities based on interests, needs, health and participation in the daily activities of the client then they plan the intervention. Occupation-based intervention will be in one-hour sessions, twice a week for six weeks.
Category
Rehabilitation

2

Description
Control group: exercise based intervention. Intervention will be performed in the form of predetermined exercises, with a specific intensity and schedule. Intervention will be 6 weeks, twice a week, 60 minutes per sessions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan MS center
Full name of responsible person
Fereshteh Ashtari
Street address
Isfehan MS center, Bahonar Ave., Hedayat Ave.
City
Isfehan
Province
Isfehan
Postal code
8158844799
Phone
+98 31 3345 8886
Email
isfahan-socity@yahoo.com
Web page address
https://clinic24h.com/projects/%D9%85%DA%A9%D8%B2-ms-%D8%A7%D8%B5%D9%81%D9%87%D8%A7%D9%86/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Mohammadreza Khodaee Ardakani
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar alley, Daneshjoo Blv., Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0016
Fax
+98 21 2218 0109
Email
amozesh@uswr.ac.ir
Web page address
http://www.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
Sara Afshar
Position
PhD candidate Student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Koodakyar dead end alley, Daneshjoo bulvar, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0037
Email
afsharsara262@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sara Afshar
Position
Phd condidate student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar dead end alley, Daneshjoo bulvar, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0036
Fax
Email
afsharsara262@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sara Afshar
Position
Phd condidate student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar dead end alley, Daneshjoo bulvar, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0036
Fax
Email
afsharsara262@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
8 months after publishing the results
To whom data/document is available
Researchers who are working in academic and scientific institutions
Under which criteria data/document could be used
The use of documents is allowed with written permission.
From where data/document is obtainable
Sara Afshar, afsharsara262@gmail.com
What processes are involved for a request to access data/document
Request by email
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