Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease
NCT07630194, Not applicable, Not yet recruiting, University of Nevada, Las Vegas
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT07630194 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Nevada, Las Vegas | ClinicalTrials.gov |
| Conditions | Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems | ClinicalTrials.gov |
| Interventions | Enjoyable Occupation-Based Cognitive Stimulation with Motivational Feedback, Enjoyable Occupation-Based Cognitive Stimulation Without Motivational Feedback, Conventional occupational therapy | ClinicalTrials.gov |
| First posted | 2026-06-05 | ClinicalTrials.gov |
| Last updated | 2026-10-01 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Canadian Occupational Performance Measure (COPM) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks). | 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. | ClinicalTrials.gov |
| Secondary | Parkinson's Disease-Cognitive Rating Scale (PD-CRS) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | 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 | ClinicalTrials.gov |
| Secondary | Montreal Cognitive Assessment (MoCA) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | 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 | ClinicalTrials.gov |
| Secondary | SCOPA-Cognition (SCOPA-Cog) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks). | 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. | ClinicalTrials.gov |
| Secondary | Stroop Test | Baseline, post-intervention (6 weeks), and follow-up (12 weeks). | 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. | ClinicalTrials.gov |
| Secondary | Clock Drawing Test (CDT) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | CDT assesses executive function, visuospatial ability, and planning. Participants draw a clock showing a specified time, and performance is scored based on accuracy of the clock face and placement of numbers and hands (range: 1-5). Lower scores indicate greater executive or visuospatial impairment. | ClinicalTrials.gov |
| Secondary | Trail Making Test (TMT) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | TMT evaluates processing speed, attention, and executive function. Part A requires sequentially connecting numbers; Part B alternates between numbers and letters. Longer completion times indicate poorer cognitive performance. | ClinicalTrials.gov |
| Secondary | Timed Up and Go Test (TUG; Single and Dual-Task) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The TUG is a performance-based measure of functional mobility rather than an item-based questionnaire. It assesses balance, gait speed, and functional mobility by timing the completion of a standardized movement sequence. The dual-task version adds a concurrent cognitive task, and longer completion times indicate poorer mobility and higher fall risk. | ClinicalTrials.gov |
| Secondary | Parkinson's Disease Questionnaire-39 (PDQ-39) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The PDQ-39 comprises 39 items across eight domains: activities of daily living, mobility, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are rated from 0 (never) to 4 (always), with higher scores indicating poorer quality of life. Domain scores are expressed as standardized percentages, and the total score is the mean of all domain scores. The PDQ-39 has demonstrated adequate internal consistency and convergent validity in Parkinson's patients with cognitive impairment, supporting its use as a valid measure of quality of life in this population. | ClinicalTrials.gov |
| Secondary | Apathy Evaluation Scale (AES) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The AES is an 18-item instrument assessing behavioral, emotional, and cognitive aspects of apathy, including motivation, interest, and goal-directed behavior. Items are rated on a 4-point Likert scale. Total scores typically range from 18 to 72, with higher scores indicating greater apathy severity. The AES-C has demonstrated robust psychometric properties, including good internal consistency, test-retest reliability, and convergent/discriminant validity in individuals with mild cognitive impairment and Alzheimer's disease. | ClinicalTrials.gov |
| Secondary | Lille Apathy Rating Scale (LARS) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The LARS is a structured interview consisting of 33 items assessing domains such as intellectual curiosity, emotional response, action initiation, and self-awareness. Items are scored using weighted responses, producing a total score ranging approximately from -36 to +36. Higher scores indicate more severe apathy. The LARS has demonstrated excellent reliability (internal consistency: Cronbach's α = 0.94; test-retest ICC = 0.94; inter-rater ICC = 0.99) and concurrent validity (correlation with NPI apathy score: r = 0.83) in patients with very mild to moderate dementia, including Alzheimer's disease, frontotemporal dementia, and primary progressive aphasia. | ClinicalTrials.gov |
| Secondary | Dimensional Apathy Scale (DAS) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The DAS contains 24 items evaluating three apathy subdomains: executive apathy, emotional apathy, and initiation apathy. Items are rated on a 4-point Likert scale. Subscale and total scores are calculated, with higher scores reflecting greater apathy severity in each domain. The DAS has demonstrated good to excellent internal consistency (self-rated Cronbach's α = 0.85; informant-rated α = 0.93) and good convergent and divergent validity against standard apathy and depression measures in Alzheimer's disease | ClinicalTrials.gov |
| Secondary | Falls Efficacy Scale-International (FES-I) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The FES-I consists of 16 items assessing concern about falling during daily physical and social activities. Each item is rated on a 4-point scale. Total scores range from 16 to 64, with higher scores indicating greater fear of falling and lower balance confidence. The FES-I has demonstrated good to excellent measurement properties, including internal reliability (Cronbach's α = 0.91-0.96) and test-retest reliability (ICC = 0.76-0.91), as well as good construct validity in geriatric patients with and without moderate cognitive impairment. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The HADS is a 14-item self-report scale assessing anxiety and depression, with seven items per subscale scored 0-3. Higher scores indicate greater symptom severity. | ClinicalTrials.gov |
| Secondary | Tampa Scale of Kinesiophobia (TSK) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The TSK consists of 17 items assessing fear of movement, injury, and re-injury during physical activity. Items are rated on a 4-point Likert scale. Total scores range from 17 to 68, with higher scores indicating greater fear of movement and avoidance behavior. | ClinicalTrials.gov |
| Secondary | Fear-Avoidance Components Scale (FACS) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The FACS contains around 16-20 items assessing fear-related beliefs, avoidance behaviors, and emotional responses related to movement or pain. Items are scored using Likert-type ratings. Higher scores indicate stronger fear-avoidance beliefs and behavioral avoidance patterns. | ClinicalTrials.gov |
| Secondary | Flow Short Scale (FSS) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The FSS measures flow during activities using 10 items rated on a 7-point Likert scale (range 10-70), with higher scores indicating greater flow. It also includes three items assessing perceived importance. | ClinicalTrials.gov |
| Secondary | Flow State Scale for Occupational Tasks | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The Flow State Scale for Occupational Tasks is a 14-item scale that assesses flow during occupational or work-related activities, including concentration, intrinsic motivation, sense of control, and time transformation. Items are rated on Likert scales and summed to produce a total score. Higher scores indicate stronger flow experience during occupational task performance. | ClinicalTrials.gov |
| Secondary | Flow State Scale for Rehabilitation Tasks (FSSOT) | Baseline, post-intervention (6 weeks), and follow-up (12 weeks) | The FSSOT assesses flow in individuals with stroke. It includes 11 items across four domains, concentration, pleasure, movement control, and absorption, rated on a 5-point Likert scale. Higher scores indicate greater flow during the activity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Clock Drawing Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)