NCT07630194Not yet recruiting
Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease
Enjoyable Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease: A Randomized Controlled Trial Protocol
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 21 Sept 2026
- Primary completion date
- 21 Jul 2028
- Lead sponsor
- University of Nevada, Las Vegas
- Diseases
- Parkinson disease
- NCT number
- NCT07630194
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 21 Sept 2026 to the primary completion date, 21 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of impulsive-compulsive disorders, confirmed through neurologist-led clinical interviews
- atypical parkinsonian syndromes, coexisting neurological disorders (e.g., stroke, other neurodegenerative diseases)
Other
- Young-onset PD
Who the study is looking for
- Idiopathic Parkinson's disease (PD) diagnosed according to the UK Parkinson's Disease Society Brain Bank criteria
- Aged 60-80 years
- Classified as Hoehn and Yahr stages I-IV
- Mild-to-moderate cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of 21-25
- Able to complete self-report measures
Age in the registry: 60 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.