Not Yet RecruitingNot Applicable

Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease

90 participantsStarted 2026-07-01

Plain-language summary

Background: Cognitive impairment and psychological symptoms are highly prevalent in Parkinson's disease (PD) and significantly compromise daily functioning and quality of life. Occupation-based cognitive stimulation may enhance ecological validity and engagement, while motivational feedback could further improve adherence and neuroplasticity. However, the combined effects of these approaches have not been systematically examined in PD. Objective: To evaluate the effects of enjoyable occupation-based cognitive stimulation with and without motivational feedback on cognitive, psychological, and occupational outcomes in older adults with PD and cognitive impairment. Methods: This single-blind, three-arm randomized controlled trial will enroll 71 community-dwelling older adults with idiopathic PD. Participants will be randomly assigned to: (A) occupation-based cognitive stimulation with motivational feedback, (B) occupation-based cognitive stimulation without motivational feedback, or (C) gold standard of conventional occupational therapy. Interventions will consist of 12 supervised sessions over 6 weeks. The primary outcome is occupational performance measured by the Canadian Occupational Performance Measure (COPM). Secondary outcomes include global and Parkinson's disease-specific cognitive function (Montreal Cognitive Assessment \[MoCA\], Parkinson's Disease-Cognitive Rating Scale \[PD-CRS\], SCOPA-Cognition, Stroop Test, Clock Drawing Test, Trail Making Test), intrinsic motivation (Intrinsic Motivation Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), apathy (Apathy Evaluation Scale, Lille Apathy Rating Scale, Dimensional Apathy Scale), quality of life (Parkinson's Disease Questionnaire-39), functional mobility (Timed Up and Go under single- and dual-task conditions), fear-related constructs (Tampa Scale of Kinesiophobia, Fear-Avoidance Components Scale, Falls Efficacy Scale-International), and flow experience during activities (Flow Short Scale and related occupational and rehabilitation flow measures). Assessments will be conducted at baseline, post-intervention, and follow-up. Data will be analyzed using linear mixed-effects models under an intention-to-treat framework. Discussion: This trial will clarify the additive value of motivational feedback in occupation-based cognitive rehabilitation for PD. Findings may inform client-centered, ecologically valid rehabilitation strategies targeting non-motor symptoms in PD.

Who can participate

Age range

60 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (a) have idiopathic PD diagnosed according to the UK Parkinson's Disease Society Brain Bank criteria; (b) have no history of impulsive-compulsive disorders, confirmed through neurologist-led clinical interviews; (c) are classified as Hoehn and Yahr stages I-IV; (d) are aged 60-80 years; (e) demonstrate mild-to-moderate cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of 21-25; and (f) are able to complete self-report measures. Exclusion Criteria: * atypical parkinsonian syndromes, coexisting neurological disorders (e.g., stroke, other neurodegenerative diseases), and young-onset PD

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Canadian Occupational Performance Measure (COPM)

Timeframe: Baseline, post-intervention (6 weeks), and follow-up (12 weeks).

Trial details

NCT IDNCT07630194

SponsorUniversity of Nevada, Las Vegas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Merrill R Landers, DPT, PhD

17028951377 merrill.landers@unlv.edu

View on ClinicalTrials.gov More Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems trials