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IRCT20140304016830N14 IRCT 2025-07-11 Iran University of Medical Sciences The effect of cognitive-functional intervention with and without motivational feedback on balance confidence and daily functioning in older adults with Parkinson's disease and fear of falling The effect of Cognitive Orientation to daily Occupational Performance (CO-OP) interventions with and without motivational feedback on balance confidence, anxiety, occupational function, activities of daily living, and functional balance and mobility in older adults with Parkinson's disease with fear of falling 2025-08-01 anticipated 75 Recruiting https://irct.ir/trial/84179 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The type of randomization used in this study is block randomization, which will be performed using the website http://www.randomizer.org by a person independent of the therapist and evaluator. Participants in different groups will have no contact with each other and will receive the interventions on different days. All participants in the three groups will be assessed before the intervention, after the intervention, and at follow-up (six weeks after the end of the intervention), Blinding description: The participants in this study will be blinded to their group allocation. Although they are aware that they are participating in a research project involving cognitive-practical interventions, they will not be informed about the number of groups, the specific differences between the groups, or the hypotheses of the study. The outcome assessors, data collectors, and the statistician responsible for data analysis will also be blinded to group allocation. The therapists delivering the interventions cannot be blinded due to the nature of the intervention. The principal investigator will not be involved in the intervention delivery or outcome assessment and will only have access to de-identified data. N/A Parkinson's disease. Intervention 1: Intervention group 1: Participants in this group will undergo a 12-session combined intervention program (60 minutes per session, twice weekly for 6 weeks). Each session begins with 20 minutes of conventional occupational therapy focusing on balance, mobility, and functional exercises. The subsequent 40 minutes are dedicated to the structured CO-OP protocol, which employs a client-centered approach to develop: (1) functional skill acquisition, (2) cognitive problem-solving strategies using the "Goal-Plan-Do-Check" framework, and (3) strategy generalization to daily life. Integrated with this process is motivational feedback based on the Human Occupation Model, featuring positive reinforcement, graded challenges tailored to individual capability, and activity meaning enhancement. This dual-focused intervention simultaneously targets functional improvement and intrinsic motivation. Intervention 2: Intervention group 2: This group follows an identical 12-session structure to Group 1 (20 minutes conventional OT + 40 minutes CO-OP protocol), with the key distinction of excluding motivational components. Therapists focus solely on delivering the cognitive-strategy training component of CO-OP (including goal-setting via COPM, problem-solving strategy development, and real-world application), deliberately omitting motivational feedback, challenge grading, or discussions about activity meaningfulness. This design allows isolation of the pure cognitive-performative effects without motivational confounders. All CO-OP protocol elements (e.g., Goal-Plan-Do-Check framework, dynamic performance analysis) are maintained with fidelity. Intervention 3: Control group: The control group participants receive 12 sessions (60 minutes each) of evidence-based standard occupational therapy for Parkinson's disease, incorporating neurodevelopmental techniques (NDT), dynamic balance exercises (e.g., directional changes, obstacle negotiation), upper/lower limb strengthening, muscle stretching, motor coordination drills, and activities of daily living (ADL) training. Therapists tailor these components to individual needs while rigorously avoiding structured cognitive strategy training or systematic motivational techniques. This conventional approach serves as an active comparator to isolate the unique effects of the CO-OP protocol beyond standard care benefits. Yes - There is a plan to make this available What will be shared: The shared file will include de-identified data from study participants. Specifically, the dataset will contain general demographic information (age, gender), group allocation, and scores related to the primary outcome measures of the study. No personal identifiers such as names, contact details, or national ID numbers will be included. Only this specific part of the data will be available to other researchers upon formal request and after obtaining appropriate approvals. The complete dataset or other sensitive information will not be shared. When: One year after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: Use of the documentation is permitted upon written permission. Where to obtain: En Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehranو Tel: 00982122227124و E-mail: taghizadeh.gh@iums.ac.ir How to obtain: Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough. Comments:
public Ghorban Taghizadeh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 taghizadeh.gh@iums.ac.ir Iran University of Medical Sciences scientific Ghorban Taghizadeh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 taghizadeh.gh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Being at the age of 65 years or older Idiopathic Parkinson’s disease confirmed by a neurologist with a disease severity of 1–3 on the Hoehn & Yahr scale Adequate cognitive function, with a score of ≥24 on the Montreal Cognitive Assessment Presence of fear of falling, confirmed by a single-item question (Yes/No) 65 years no limit Both Comorbid neurological/orthopedic conditions affecting mobility, per physician report Substance abuse History of diabetes mellitus G20 Parkinson's disease Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Participants in this group will undergo a 12-session combined intervention program (60 minutes per session, twice weekly for 6 weeks). Each session begins with 20 minutes of conventional occupational therapy focusing on balance, mobility, and functional exercises. The subsequent 40 minutes are dedicated to the structured CO-OP protocol, which employs a client-centered approach to develop: (1) functional skill acquisition, (2) cognitive problem-solving strategies using the "Goal-Plan-Do-Check" framework, and (3) strategy generalization to daily life. Integrated with this process is motivational feedback based on the Human Occupation Model, featuring positive reinforcement, graded challenges tailored to individual capability, and activity meaning enhancement. This dual-focused intervention simultaneously targets functional improvement and intrinsic motivation. Intervention group 2: This group follows an identical 12-session structure to Group 1 (20 minutes conventional OT + 40 minutes CO-OP protocol), with the key distinction of excluding motivational components. Therapists focus solely on delivering the cognitive-strategy training component of CO-OP (including goal-setting via COPM, problem-solving strategy development, and real-world application), deliberately omitting motivational feedback, challenge grading, or discussions about activity meaningfulness. This design allows isolation of the pure cognitive-performative effects without motivational confounders. All CO-OP protocol elements (e.g., Goal-Plan-Do-Check framework, dynamic performance analysis) are maintained with fidelity. Control group: The control group participants receive 12 sessions (60 minutes each) of evidence-based standard occupational therapy for Parkinson's disease, incorporating neurodevelopmental techniques (NDT), dynamic balance exercises (e.g., directional changes, obstacle negotiation), upper/lower limb strengthening, muscle stretching, motor coordination drills, and activities of daily living (ADL) training. Therapists tailor these components to individual needs while rigorously avoiding structured cognitive strategy training or systematic motivational techniques. This conventional approach serves as an active comparator to isolate the unique effects of the CO-OP protocol beyond standard care benefits. Satisfaction of performance. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: The score of satisfaction with performance will be measured using the Canadian Occupational Performance Measure (COPM). This score reflects the participants' level of satisfaction with their performance in daily activities, rated on a 10-point scale, where higher scores indicate greater satisfaction. Performance. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: The performance score will be measured using the Canadian Occupational Performance Measure (COPM). This score reflects the participants' level of performance in daily activities and is recorded on a 10-point scale, where higher scores indicate better performance. Functional mobility. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Timed Up and Go (TUG) Test. Self-reported confidence in maintaining balance during daily activities. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Activities-specific Balance Confidence (ABC). Assesses the individual's ability to maintain static and dynamic balance through 14 different tasks (e.g., standing unsupported, turning, picking up objects). Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Berg Balance Scale (BBS). Adaptability of gait during complex walking tasks. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Dynamic Gait Index - DGI. Activities of Daily Living (ADL) independence. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Barthel Index - BI. Intrinsic motivation. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Intrinsic Motivation Inventory - IMI. Quality of life. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Parkinson's Disease Questionnaire (PDQ-39). Frequency and perceived meaningfulness of 28 daily activities. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Meaningful Activity Participation. Disability in daily activities specific to PD. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: UPDRS-ADL. Concern about falling during daily activities. Timepoint: Baseline, post-intervention (week 12), and follow-up (week 18). Method of measurement: Falls Efficacy Scale-International. Iran University of Medical Sciences Approved 2025-06-09 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), next to Milad Tower, Hemmat Expressway, Postal Code: 1449614535 Tehran Tehran Iran (Islamic Republic of)