A 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: study protocol for a randomized controlled trial

Abstract Background Parkinson’s disease (PD) is a neurodegenerative disorder with debilitating motor and non-motor symptoms which affect participation in meaningful occupations. Occupation-based interventions can improve participation in people with PD. Evidence for incorporating structured and inte...

Full description

Bibliographic Details
Main Authors: Mahsa Meimandi, Akram Azad, Jafar Haj Ghani, Fatemeh HojabriFard, Philip von Rosen, Naeeme Haji Alizadeh, Ghorban Taghizadeh
Format: Article
Language:English
Published: BMC 2023-09-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-023-07526-3
_version_ 1797556658958761984
author Mahsa Meimandi
Akram Azad
Jafar Haj Ghani
Fatemeh HojabriFard
Philip von Rosen
Naeeme Haji Alizadeh
Ghorban Taghizadeh
author_facet Mahsa Meimandi
Akram Azad
Jafar Haj Ghani
Fatemeh HojabriFard
Philip von Rosen
Naeeme Haji Alizadeh
Ghorban Taghizadeh
author_sort Mahsa Meimandi
collection DOAJ
description Abstract Background Parkinson’s disease (PD) is a neurodegenerative disorder with debilitating motor and non-motor symptoms which affect participation in meaningful occupations. Occupation-based interventions can improve participation in people with PD. Evidence for incorporating structured and intensive occupational therapy by considering the concept of responsibility is lacking for this population. This trial will compare the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic PD. Methods A total of 45 people with PD, between 35 and 85 years old and Hoehn and Yahr stages between I to III, will be recruited from movement disorder centers for this three-armed study. Participants will be randomized into three groups (occupation-based interventions with responsibility feedback, occupation-based interventions without responsibility feedback, and conventional interventions). All participants will receive intervention for 24 sessions during a period of 12 weeks (2 sessions per week). The primary outcome measure will be participation satisfaction. Participation frequency and restriction, self-perceived performance, performance satisfaction, motivation, volition, sense of agency, responsibility, physical activity, community integration, activities of daily living (ADL), instrumental ADL, upper extremity function, balance, fatigue, and quality of life will be measured as secondary outcome measures. All outcomes will be measured at baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Discussion This home-based high-intensity, structured, client-centered, and occupation-based intervention will be conducted by utilizing the concept of responsibility. This proposed trial may result in enhanced participation that would benefit other motor and non-motor symptoms in people living with PD. Findings from this proposed study are expected to expand the knowledge of clinicians and help them in evidence-based decision-making processes. Trial registration Iranian Registry of Clinical Trials IRCT20140304016830N13. Registered on August 19, 2022
first_indexed 2024-03-10T17:05:59Z
format Article
id doaj.art-7b72028c9ec6446c8dc5520fb742312f
institution Directory Open Access Journal
issn 1745-6215
language English
last_indexed 2024-03-10T17:05:59Z
publishDate 2023-09-01
publisher BMC
record_format Article
series Trials
spelling doaj.art-7b72028c9ec6446c8dc5520fb742312f2023-11-20T10:49:15ZengBMCTrials1745-62152023-09-0124111110.1186/s13063-023-07526-3A 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: study protocol for a randomized controlled trialMahsa Meimandi0Akram Azad1Jafar Haj Ghani2Fatemeh HojabriFard3Philip von Rosen4Naeeme Haji Alizadeh5Ghorban Taghizadeh6Rehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical SciencesRehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical SciencesRehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical SciencesDepartment of Occupational Therapy, School of Rehabilitation, Shahid Beheshti University of Medical SciencesDivision of Physiotherapy, Department of Neurobiology, Care Sciences, and Society (NVS), Karolinska InstitutetDepartment of Neuroscience, School of Advanced Technology in Medicine, Iran University of Medical Sciences (IUMS)Rehabilitation Research Center, Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical SciencesAbstract Background Parkinson’s disease (PD) is a neurodegenerative disorder with debilitating motor and non-motor symptoms which affect participation in meaningful occupations. Occupation-based interventions can improve participation in people with PD. Evidence for incorporating structured and intensive occupational therapy by considering the concept of responsibility is lacking for this population. This trial will compare the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic PD. Methods A total of 45 people with PD, between 35 and 85 years old and Hoehn and Yahr stages between I to III, will be recruited from movement disorder centers for this three-armed study. Participants will be randomized into three groups (occupation-based interventions with responsibility feedback, occupation-based interventions without responsibility feedback, and conventional interventions). All participants will receive intervention for 24 sessions during a period of 12 weeks (2 sessions per week). The primary outcome measure will be participation satisfaction. Participation frequency and restriction, self-perceived performance, performance satisfaction, motivation, volition, sense of agency, responsibility, physical activity, community integration, activities of daily living (ADL), instrumental ADL, upper extremity function, balance, fatigue, and quality of life will be measured as secondary outcome measures. All outcomes will be measured at baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Discussion This home-based high-intensity, structured, client-centered, and occupation-based intervention will be conducted by utilizing the concept of responsibility. This proposed trial may result in enhanced participation that would benefit other motor and non-motor symptoms in people living with PD. Findings from this proposed study are expected to expand the knowledge of clinicians and help them in evidence-based decision-making processes. Trial registration Iranian Registry of Clinical Trials IRCT20140304016830N13. Registered on August 19, 2022https://doi.org/10.1186/s13063-023-07526-3OccupationsOccupational therapyParkinson’s diseaseParticipationRehabilitation
spellingShingle Mahsa Meimandi
Akram Azad
Jafar Haj Ghani
Fatemeh HojabriFard
Philip von Rosen
Naeeme Haji Alizadeh
Ghorban Taghizadeh
A 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: study protocol for a randomized controlled trial
Trials
Occupations
Occupational therapy
Parkinson’s disease
Participation
Rehabilitation
title A 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: study protocol for a randomized controlled trial
title_full A 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: study protocol for a randomized controlled trial
title_fullStr A 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: study protocol for a randomized controlled trial
title_full_unstemmed A 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: study protocol for a randomized controlled trial
title_short A 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: study protocol for a randomized controlled trial
title_sort 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 study protocol for a randomized controlled trial
topic Occupations
Occupational therapy
Parkinson’s disease
Participation
Rehabilitation
url https://doi.org/10.1186/s13063-023-07526-3
work_keys_str_mv AT mahsameimandi acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT akramazad acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT jafarhajghani acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT fatemehhojabrifard acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT philipvonrosen acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT naeemehajializadeh acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT ghorbantaghizadeh acomparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT mahsameimandi comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT akramazad comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT jafarhajghani comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT fatemehhojabrifard comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT philipvonrosen comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT naeemehajializadeh comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial
AT ghorbantaghizadeh comparisonoftheeffectsofoccupationbasedinterventionswithandwithoutresponsibilityfeedbackandconventionalinterventionsonparticipationinpeoplewithidiopathicparkinsonsdiseasestudyprotocolforarandomizedcontrolledtrial