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

NCT07630194 | Not Yet Recruiting

• 1 other identifier: IRCT20140612018077N4
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cognition; Occupational therapy; Quality of life; Feedback; motivation

Outcome Measures

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.

  Baseline, post-intervention (6 weeks), and follow-up (12 weeks).

Secondary Outcomes (18)

• Parkinson's Disease-Cognitive Rating Scale (PD-CRS)

  Baseline, post-intervention (6 weeks), and follow-up (12 weeks)

• Montreal Cognitive Assessment (MoCA)

  Baseline, post-intervention (6 weeks), and follow-up (12 weeks)

• SCOPA-Cognition (SCOPA-Cog)

  Baseline, post-intervention (6 weeks), and follow-up (12 weeks).

• Stroop Test

  Baseline, post-intervention (6 weeks), and follow-up (12 weeks).

• Clock Drawing Test (CDT)

  Baseline, post-intervention (6 weeks), and follow-up (12 weeks)

Study Arms (3)

Occupation-based cognitive stimulation with motivational feedback

EXPERIMENTAL

Participants will receive cognitively stimulating interventions embedded in enjoyable and meaningful occupations, with structured motivational feedback.

Behavioral: Enjoyable Occupation-Based Cognitive Stimulation with Motivational Feedback

Occupation-based cognitive stimulation without motivational feedback

EXPERIMENTAL

Participants will receive the same occupation-based cognitive interventions as the first group but it will be delivered without motivational feedback

Behavioral: Enjoyable Occupation-Based Cognitive Stimulation Without Motivational Feedback

Conventional care

ACTIVE COMPARATOR

Participants will receive standard occupational therapy (60 minutes/session).

Behavioral: Conventional occupational therapy

Interventions

Enjoyable Occupation-Based Cognitive Stimulation with Motivational Feedback BEHAVIORAL

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.

Occupation-based cognitive stimulation with motivational feedback

Enjoyable Occupation-Based Cognitive Stimulation Without Motivational Feedback BEHAVIORAL

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.

Occupation-based cognitive stimulation without motivational feedback

Conventional occupational therapy BEHAVIORAL

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.

Conventional care

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) have idiopathic PD diagnosed according to the UK Parkinson's Disease Society Brain Bank criteria; (b) have no history of impulsive-compulsive disorders, confirmed through neurologist-led clinical interviews; (c) are classified as Hoehn and Yahr stages I-IV; (d) are aged 60-80 years; (e) demonstrate mild-to-moderate cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of 21-25; and (f) are able to complete self-report measures.

You may not qualify if:

• atypical parkinsonian syndromes, coexisting neurological disorders (e.g., stroke, other neurodegenerative diseases), and young-onset PD

Sponsors & Collaborators

• Iran University of Medical Sciences: collaborator
• University of Nevada, Las Vegas: lead

Central Study Contacts

Merrill R Landers, DPT, PhD

CONTACT

17028951377; merrill.landers@unlv.edu

Maryam Mehdizadeh, PhD

CONTACT

Taghizadeh.gh@iums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Data will be collected by a research assistant who is an occupational therapist with six years of experience in neurological rehabilitation. The assistant will conduct eligibility screening and all outcome assessments at predefined time points and will remain blinded to group allocation, study purpose, treatment delivery, and randomization procedures. Outcome assessors will remain blinded to group allocation throughout the study. Participants will be blinded to group allocation and specific study hypotheses. Unblinding is not anticipated; however, if required, access to allocation codes will be restricted to the trial steering committee, and all unblinding events will be documented. Outcome assessments will be conducted by a blinded occupational therapist at baseline, post-intervention (6 weeks), and follow-up (12 weeks).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a parallel, three-arm randomized controlled trial (RCT) with blinded outcome assessment. Participants will be randomized (1:1:1) to: (A) occupation-based cognitive stimulation with motivational feedback, (B) occupation-based cognitive stimulation without motivational feedback, or (C) conventional care. The trial follows a superiority design comparing both intervention arms and conventional care. Randomization will occur after baseline assessment, with blinded outcome assessors and participants blinded to study hypotheses.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06