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.

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.