Comparison of the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic Parkinson’s disease
The aim of the present study is to compare the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic Parkinson’s disease.
Design
This study is a parallel and double blinded randomized controlled trial with three groups. Forty-five patients will be randomly assigned to three groups (occupation-based interventions with responsibility feedback, occupation-based interventions without responsibility feedback, and conventional interventions). An independent researcher who is blind to patient assignments will evaluate the primary and secondary outcomes. Patients will also be blinded to group allocation.
Settings and conduct
This study will be conducted in patients’ homes. The control group will receive conventional occupational therapy interventions. Interventional groups, in addition to conventional interventions, will receive occupation-based interventions (2 sessions per week, 60 to 90 minutes) with or without responsibility feedback.
Participants/Inclusion and exclusion criteria
People with idiopathic Parkinson’s disease will be recruited from Movement Disorders centers. Inclusion criteria include: diagnosis of idiopathic Parkinson’s disease based on UK Brain bank criterias, disease progression level based on Hoehn and Yahr stages of I to III, acceptable cognitive function (a score of >24 based on Montreal Cognitive Assessment), ability to read and write in Persian. Patients with impulsive-compulsive disorders, atypical parkinsonian syndromes, juvenile Parkinson’s disease and other neurological disorders such as stroke will be excluded.
Intervention groups
Occupation-based interventions with responsibility feedback; Occupation-based interventions without responsibility feedback; Conventional interventions
Main outcome variables
Participation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140304016830N13
Registration date:2022-08-19, 1401/05/28
Registration timing:prospective
Last update:2022-08-19, 1401/05/28
Update count:0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Ghorban Taghizadeh
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
taghizadeh.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-29, 1401/06/07
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic Parkinson’s disease
Public title
The effect of occupational therapy interventions on participation in people with idiopathic Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of idiopathic Parkinson’s disease based on UK Brain Bank criteria according to neurologist
Disease progression level based on Hoehn and Yahr stages of I to III
Acceptable cognitive function (a score of > 24 on Montreal Cognitive Assessment
Ability to read and write in Persian to complete self-reported questionnaires
Exclusion criteria:
Atypical parkinsonian syndromes
Other existing neurological disorders, such as stroke
Juvenile Parkinson’s Disease
Impulsive-compulsive disorders
Age
From 35 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who enter the study will be randomly assigned to one of the three groups: A: Occupation-based interventions with responsibility feedback; B: Occupation-based interventions without responsibility feedback; C: Conventional interventions. Participants will be randomly assigned to each group using a sequence generated by http://www.randomizer.org. For determining concealment, unique codes will be written on envelopes which contains group specifications.
Blinding (investigator's opinion)
Double blinded
Blinding description
An independent researcher who is blind to patient assignments will evaluate primary and secondary outcomes. To keep the assessor blind, patients and therapists will be asked not to specify the received intervention or experience regarding the study to assessor. Patients will also be blind to group assignments. To keep patients blind, patients in different groups will not be able to communicate with each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
First Intervention group: This group will receive occupation-based interventions with responsibility feedbacks for 24 sessions (12 weeks, two sessions per week). Participants will receive occupations from simple (stationary condition with no intertrial variability and object manipulation) to hard (in-motion conditions with intertrial variability and object manipulation) levels based on their priorities identified via Canadian Occupational Performance Measure. Moreover, feedback statements that have the potential to create a sense of responsibility (derived from international and national Delphi studies with renowned experts and patients) in patients will be provided to participants as knowledge of performance or knowledge of result. These feedback statements are positive or negative statements in relation to the individual or his/her family. This group will receive conventional interventions for 15 minutes in each session. Participants in this group will receive occupation-based interventions with responsibility feedback for the remaining 45 to 75 minutes.
Category
Rehabilitation
2
Description
Second Intervention group: This group will receive occupation-based interventions with responsibility feedbacks for 24 sessions (12 weeks, two sessions per week). Responsibility feedbacks will not be provided to this group. This group will also receive 15 minutes conventional interventions and 45 to 75 minutes occupation-based interventions.
Category
Rehabilitation
3
Description
Control group: Participants who are assigned to this group will only receive traditional treatment for 24 sessions (12 weeks, 2 sessions per week, 60 to 90 minutes), including passive mobilization, lower extremity strengthening, stretching, motor coordination (upper and lower extremity), balance and walking training, manipulation exercises, breathing, relaxation, and postural exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Movement Disorder centers and rehabilitation clinics
Full name of responsible person
Ghorban Taghizadeh
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Iran University of Medical Sciences, Dr. Yunes Panahi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
yunespanahi@yahoo.com
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
Ghorban Taghizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
ََAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.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
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
One year after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of the documentation is permitted upon written permission.
From where data/document is obtainable
Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehranو Tel: 00982122227124و E-mail: taghizadeh.gh@iums.ac.ir
What processes are involved for a request to access data/document
Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.