NCT07611578

Brief Summary

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor and cognitive impairments that substantially reduce functional independence, social participation, and quality of life. A key psychosocial factor affected by these impairments is self-efficacy, defined as an individual's belief in their ability to successfully perform tasks and achieve personal goals. In people with PD, reduced self-efficacy is closely associated with motor dysfunction, cognitive decline, fear of falling, depressive symptoms, and decreased motivation for physical and social activities. These factors interact in a bidirectional manner, creating a negative cycle in which poor confidence limits participation, further accelerating functional deterioration. From a neurophysiological perspective, the degeneration of dopaminergic neurons in PD disrupts the automatic control of movement. As a consequence, individuals with PD rely more heavily on cognitive and attentional resources to execute daily motor activities. This reliance becomes particularly problematic in dual-tasking situations, where two tasks must be performed simultaneously, such as a motor task combined with a cognitive task or two concurrent motor tasks. Because attentional capacity is limited, dividing attention across tasks frequently results in performance declines in one or both tasks, a phenomenon referred to as dual-task interference or dual-task cost. Low confidence when facing these situations may reinforce avoidance behaviors, thereby further diminishing physical activity and community engagement. Dual-task training has been proposed as a rehabilitation strategy to improve functional performance, self-efficacy, and daily functioning in people with PD. However, important gaps remain in the evidence. It is currently unclear whether motor-cognitive or motor-motor dual-task training is more effective, particularly when considering the presence or absence of cognitive impairment. Additionally, the relative impact of secondary cognitive versus secondary motor tasks on primary motor task performance has not been well established. Another unresolved issue concerns attentional prioritization strategies during dual-task training. Fixed-priority strategies require individuals to attend equally to both tasks, whereas variable-priority strategies involve alternating attention between tasks. The optimal strategy for individuals with PD, especially those with cognitive deficits, remains unknown. The proposed research aims to address these knowledge gaps by systematically evaluating the effects of different dual-task training modalities and attentional prioritization strategies on self-efficacy, functional performance, and quality of life in individuals with PD, both with and without cognitive impairment. An additional objective is to investigate whether improvements in dual-task performance are associated with reduced attentional demands, as reflected by decreased activity in the prefrontal cortex, which is considered a key neural marker of cognitive load during task performance. The research program comprises two complementary studies. Study 1 is a randomized clinical trial with a factorial design stratified by cognitive status. Participants with PD are randomly assigned to one of four intervention groups combining dual-task modality (motor-cognitive or motor-motor) with attentional strategy (fixed-priority or variable-priority). All participants undergo baseline assessments conducted by an interdisciplinary team and complete 24 individualized training sessions over an eight-week period. Outcome measures include self-efficacy, motor and cognitive performance, quality of life, dual-task cost, and prefrontal cortex activity. Study 2 uses a cross-sectional design that includes individuals with PD from study 1 and a matched group of healthy older adults. Using identical assessment procedures, this study compares dual-task interference and prefrontal cortex activity between people with PD and healthy controls, providing additional insight into disease-specific cognitive-motor interactions. Overall, this research seeks to inform evidence-based, personalized rehabilitation strategies by identifying the most effective dual-task training approaches for improving confidence, functional ability, and quality of life in individuals with PD.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jan 2029

First Submitted

Initial submission to the registry

May 7, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

May 7, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

dual taskingmotor cognitive trainingcognitive functionself efficacy

Outcome Measures

Primary Outcomes (9)

  • Self-efficacy (The Latin Spanish version of the Self-Efficacy to Manage Chronic Disease for the Chilean population )

    Self-efficacy is the perceived ability to perform specific tasks to achieve concrete goals successfully. The Latin Spanish version of the Self-Efficacy to Manage Chronic Disease for the Chilean population (SEMCD-S) will be used for this outcome. In the SEMCD-S, participants rank each one of the 4 items from 0 to 10. Higher scores indicate higher self-efficacy.

    From enrollment to the end of treatment at 8 weeks

  • Self-efficacy (General Self-Efficacy Scale)

    Self-efficacy is the perceived ability to perform specific tasks to achieve concrete goals successfully. The General Self-Efficacy scale (GSES) will be used for this outcome. In the GSES, participants rank each one of the 10 items from 0 to 7. Higher scores indicate higher self-efficacy.

    From enrollment to the end of treatment at 8 weeks

  • Unified Parkinson's Disease Rating Scale (revised version)

    The sections II and III of the Unified Parkinson's Disease Rating Scale (revised version) will be used to analyse the effect of the intervention on activities of daily life and clinical motor aspects of the disease. The scale ranks from 0 to 199. Higher score indicates worse performance.

    From enrollment to the end of treatment at 8 weeks

  • Balance

    Static and dinamic balance during functional activities will be measured using the Mini Best Test.The Mini BesTest has demonstrated to be valid and reliable clinical measure for assessing static and dinamic balance in individuals with Parkinson's disease. The test ranks from 0 to 28 points.Higher scores indicates better performance

    From enrollment to the end of treatment at 8 weeks

  • Gait (walking speed)

    Spatiotemporal gait parameters under single and dual-task conditions will be measured using a pressure-sensitive mat. During the single-task condition, participants will be asked to walk at a self-selected walking speed covering 10 meters. Under dual-task condition, participants will be asked to perform the same as above while performing cognitive tasks. Walking speed (m/s) will be recorded for analysis

    From enrollment to the end of treatment at 8 weeks

  • Cognitive function

    The Serial Threes Test (STT) and the auditory Stroop task will be used to evaluate cognitive functions under single and dual-task conditions. The STT requires participants to make multiple subtractions of three from a whole three-digit number, e.g., 256, 253, 250, 247. Different three-digit numbers will be used for each trial to reduce the learning effect. The auditory Stroop task require participants to verbally respond to congruent and incongruent high and low tones. Participants will hear the words "high" and "low" that were recorded in either a high or low pitch. Participants will be asked to ignore the actual word presented and indicate the pitch of the word they heard. The STT and the auditory Stroop task will be used because they are demonstrated to be sensitive to detect changes as well as feasible, reliable, and valid during dual tasking in individuals with PD. Number of correct responses will be recorder for further analysis and calculate single and dual task cost.

    From enrollment to the end of treatment at 8 weeks

  • Brain activity of the Prefrontal cortex

    The hemodynamic activity of the prefrontal and motor cortices will be measured using a functional Near-Infrared Spectroscopy system under single and dual-task conditions. A head cap containing two light emitters and detectors (devices) will be placed on the scalp on the right and left side of the forehead of each participant. In the sagittal plane, both detectors will be placed at a distance of 15% of the length of the nasion-inion starting from the nasion. In the transverse plane each detector will be placed 7% of the head circumference starting from the midline. The devices will be protected against ambient light using a black cloth covering the entire forehead. Raw data will be converted to relative changes in oxygenated and deoxygenated haemoglobin concentrations using the modified Lambert-Beer law.

    From enrollment to the end of treatment at 8 weeks

  • Dual task cost

    Dual-task cost values will be calculated to compare the performance on dual task modality using the following formula: dual task cost (%)=((dual task performance-single task performance)/single task performance)\*100. Negative values indicate deteriorated performance in the dual task relative to the single task. Positive values indicates a relative improvement relative to the single task.

    From enrollment to the end of treatment at 8 weeks

  • Difficulties associated with Parkinson's disease

    How often individuals with Parkinson's disease expereince difficulties will be measured using the Spanish version of the Parkinson's disease questionnaire (PDQ-39). This instrument includes 39 questions distributed in eight domains where 0% is no problem and 100% is maximum level of problem.This instrument has an official version for Chilean population.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Gait (stride length)

    From enrollment to the end of treatment at 8 weeks

  • Gait (cadence)

    From enrollment to the end of treatment at 8 weeks

Study Arms (8)

No cognitive impairment, motor cognitive training, fixed priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and no cognitive impairments will perform motor cognitive training and will be instructed to focus attention on both tasks (motor and cognitive) through the entire session.

Other: dual tasking training

No cognitive impairment, motor cognitive training, variable priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and no cognitive impairments will perform motor cognitive training and will be instructed to focus attention on the motor tasks during half of the training session and on the secondary cognitive task during the second half of the training session.

Other: dual tasking training

No cognitive impairment, motor dual task training, fixed priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and no cognitive impairments will perform motor dual task training (two motor tasks) and will be instructed to focus attention on both motor tasks through the entire session.

Other: dual tasking training

No cognitive impairment, motor dual task training, variable priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and no cognitive impairments will perform motor dual task training (two motor tasks) and will be instructed to focus attention on the first motor task during half of the training session and on the secondary motor task during the second half of the training session.

Other: dual tasking training

Cognitive impairment, motor cognitive training, fixed priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and cognitive impairments will perform motor cognitive training and will be instructed to focus attention on both tasks (motor and cognitive) through the entire session.

Other: dual tasking training

Cognitive impairment, motor cognitive training, variable priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and cognitive impairments will perform motor cognitive training and will be instructed to focus attention on the first motor tasks during half of the training session and on the secondary cognitive task during the second half of the training session.

Other: dual tasking training

Cognitive impairment, motor dual task training, fixed priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and cognitive impairments will perform motor dual task training (two motor tasks) and will be instructed to focus attention on both motor tasks through the entire session.

Other: dual tasking training

Cognitive impairment, motor dual task training, variable priority instructions

EXPERIMENTAL

In this group, participants with Parkinson's disease and cognitive impairments will perform motor dual task training (two motor tasks) and will be instructed to focus attention on the first motor task during half of the training session and on the secondary motor task during the second half of the training session.

Other: dual tasking training

Interventions

Dual-tasking refers to the simultaneous performance of two tasks that compete for shared cognitive and/or motor resources. Typically, one task is motor (e.g., gait, balance, or upper-limb activity) and the other is cognitive (e.g., attention, executive function, or memory). The degree of performance decrement observed in one or both tasks commonly termed dual-task interference or dual-task cost is used as an index of cognitive motor integration and attentional resource allocation. Dual-task can be classified according to the nature of the paired task: Motor Cognitive Dual Tasks is the combination of a motor task with a cognitive task. Motor-Motor Dual Tasks is the concurrent execution of two motor tasks.Dual-task performance can be modulated by explicit or implicit prioritization strategies. Participants can be instructed to allocate attention equally to both tasks or to alternate prioritization between tasks, either across trials or within the same session

Cognitive impairment, motor cognitive training, fixed priority instructionsCognitive impairment, motor cognitive training, variable priority instructionsCognitive impairment, motor dual task training, fixed priority instructionsCognitive impairment, motor dual task training, variable priority instructionsNo cognitive impairment, motor cognitive training, fixed priority instructionsNo cognitive impairment, motor cognitive training, variable priority instructionsNo cognitive impairment, motor dual task training, fixed priority instructionsNo cognitive impairment, motor dual task training, variable priority instructions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hoehn \& Yahr stages I, II or III
  • Participants with no or mild to moderate neurocognitive impairments
  • Participants with and without symptoms of depression
  • Able to walk independently
  • Unaltered dose and type of medication up to three months before the commencement of the study
  • Participants able to understand and respond to the instructions given in the study.

You may not qualify if:

  • The presence of any other concomitant neurological, musculoskeletal disease
  • History of leg or brain trauma or surgery
  • Vision or hearing problems that may affect the performance of cognitive tests
  • Clinical diagnosis of major neurocognitive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Casona de Las Condes

Santiago, Las Condes, Chile

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: This study will employ a two by two nested factorial experimental design nested in a factor variable (no cognitive impairment versus mild cognitive impairment). Participants with Parkinson's disease will be allocated to each group using the block randomization method. Allocation concealment will be implemented using sequential sealed envelopes prepared by a research assistant independent from the research team.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 28, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations