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

Study acronym: EOBCS
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Start date: Jul 1, 2026 to Sep 21, 2026 Show 4 more changesShow less
    • Primary and study completion dates: Jul 1, 2028 to Jul 21, 2028
    • Secondary endpoints: details revised at 18 of 18 entries
    • Study description shortened, about 10 words
    • Eligibility criteria shortened, about 5 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07630194
Lead Sponsor University of Nevada, Las Vegas
Collaborators: Iran University of Medical Sciences
Conditions
(from sponsor)
Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov