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IRCT20140304016830N13 IRCT 2022-08-19 Iran University of Medical Sciences The effect of occupational therapy interventions on participation in people with idiopathic Parkinson's disease 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 2022-08-29 anticipated 45 Complete https://irct.ir/trial/64782 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Parkinson's disease. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: 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: One year after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: Use of the documentation is permitted upon written permission. Where to obtain: Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehranو Tel: 00982122227124و E-mail: taghizadeh.gh@iums.ac.ir How to obtain: Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough. Comments:
public Ghorban Taghizadeh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 taghizadeh.gh@iums.ac.ir Iran University of Medical Sciences scientific Ghorban Taghizadeh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 taghizadeh.gh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 35 years 85 years Both Atypical parkinsonian syndromes Other existing neurological disorders, such as stroke Juvenile Parkinson’s Disease Impulsive-compulsive disorders G20 Parkinson's disease Rehabilitation Rehabilitation Rehabilitation 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. 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. 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. Participation satisfaction. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Utrecht Scale for Evaluation of Rehabilitation-Participation Satisfaction. Participation frequency and restriction. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Utrecht Scale for Evaluation of Rehabilitation-Frequency and restriction scales. Self-perceived performance and performance satisfaction. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Canadian Occupational Performance Measure. Motivation. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Social Motivation Questionnaire. Volition. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Volitional Questionnaire. Sense of agency. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Intentional Binding Task. Responsibility. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Allocation of Treatment Responsibility Scale. Physical activity. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Phone Frequency, Intensity, Time, and Type (Phone-FITT) Questionnaire. Community integration. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Community Integration Questionnaire-Revised. Activities of daily living and Instrumental activities of daily living. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Nottingham Extended ADL Scale. Upper extremity function. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: 9-hole peg Test. Fatigue. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Fatigue severity scale. Quality of life. Timepoint: Baseline, session 9, session 17, post-intervention (week 13), and follow-up (week 25). Method of measurement: Parkinson's Disease Questionnaire (PDQ-39). Iran University of Medical Sciences Approved 2021-11-21 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)