Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease
NCT07630194 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-06-05
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.
Conditions
- Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Interventions
- BEHAVIORAL
-
Enjoyable Occupation-Based Cognitive Stimulation with Motivational Feedback
Participants will receive cognitively stimulating, occupation-based interventions (e.g., cooking, gardening, painting) graded using Gentile's taxonomy and tailored to individual functional levels and COPM-identified priorities. Each participant will engage in three to four activities with equivalent exposure; task engagement will be rated post-session using a 10-cm VAS. Motivational feedback-emphasizing effort, progress, and enjoyment, informed by Delphi studies-will be standardized across sessions. Each session will comprise 45 minutes of occupation-based cognitive stimulation and 15 minutes of conventional occupational therapy (mobilization, stretching, strengthening, coordination, balance, gait, and breathing exercises), delivered one-to-one with adjusted repetitions.
- BEHAVIORAL
-
Enjoyable Occupation-Based Cognitive Stimulation Without Motivational Feedback
Participants in this group will receive the same occupation-based cognitive interventions as the first group, delivered for 45 minutes without motivational feedback, in addition to 15 minutes of conventional occupational therapy.
- BEHAVIORAL
-
Conventional occupational therapy
Participants will receive standard occupational therapy (60 minutes/session). As preparatory methods to enable engagement in meaningful occupations, sessions include passive mobilization, stretching, strengthening, motor coordination, balance and gait training, postural exercises, and breathing/relaxation techniques. These components are means to support performance in self-care, productivity, and leisure. Intervention type, duration, and intensity will be documented.
Sponsors & Collaborators
-
Iran University of Medical Sciences
collaborator OTHER -
University of Nevada, Las Vegas
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-07-01
- Completion
- 2028-07-01
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