Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversity of Nevada, Las Vegas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of impulsive-compulsive disorders, confirmed through neurologist-led clinical interviews
atypical parkinsonian syndromes, coexisting neurological disorders (e.g., stroke, other neurodegenerative diseases)
Young-onset PD
Trial design
Design model
Parallel
Treatments tested in this trial
Enjoyable Occupation-Based Cognitive Stimulation with Motivational Feedback
BehavioralParticipants will receive cognitively stimulating, occupation-based interventions (e.g., cooking, gardening, painting) graded using Gentile's taxonomy and tailored to individual functional levels and Canadian Occupational Performance Measure (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 visual analog scale. 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.
Enjoyable Occupation-Based Cognitive Stimulation Without Motivational Feedback
BehavioralParticipants 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.
Conventional occupational therapy
BehavioralParticipants 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Occupation-based cognitive stimulation with motivational feedbackExperimental treatment 1 intervention
Group B: Occupation-based cognitive stimulation without motivational feedbackExperimental treatment 1 intervention
Group C: Conventional careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Canadian Occupational Performance Measure (COPM)
The COPM is a semi-structured, interview-based measure assessing perceived performance and satisfaction in self-care, productivity, and leisure. Participants identify relevant activities and rate performance and satisfaction on a 0-10 scale, with higher scores indicating better outcomes. The COPM has demonstrated reliability and validity in older adults with mild cognitive impairment.
Time frame
Baseline, post-intervention (6 weeks), and follow-up (12 weeks).Secondary outcomes
1
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
PD-CRS is a Parkinson's disease (PD)-specific cognitive assessment comprising cortical (memory, language, executive function) and subcortical (attention, working memory) domains. Total scores range from 0 to 134, with lower scores indicating greater cognitive impairment
Time frame
Baseline, post-intervention (6 weeks), and follow-up (12 weeks)2
Montreal Cognitive Assessment (MoCA)
The MoCA is a global cognitive screening tool assessing memory, visuospatial ability, executive function, attention, working memory, language, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function; one point is added for individuals with fewer than 12 years of education
Time frame
Baseline, post-intervention (6 weeks), and follow-up (12 weeks)3
SCOPA-Cognition (SCOPA-Cog)
SCOPA-Cog is a brief, validated measure of cognitive function in PD assessing memory, attention, executive function, and processing speed. Scores range from 0 to 43, with higher scores indicating better cognitive performance and suitability for rapid screening and longitudinal monitoring.
Time frame
Baseline, post-intervention (6 weeks), and follow-up (12 weeks).4
Stroop Test
Stroop Test assesses selective attention, processing speed, and cognitive control through color-word interference tasks. Response time and error rates are recorded, with longer times and more errors indicating greater impairment.
Time frame
Baseline, post-intervention (6 weeks), and follow-up (12 weeks).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nevada, Las Vegas
Lead sponsor
Iran University of Medical Sciences
Collaborator
Source ClinicalTrials.gov
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