Campus Casona de Las Condes
Santiago, Las Condes, Chile
NCT Number: NCT07611578
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Santiago, Las Condes, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants diagnosed with idiopathic Parkinson's disease confirmed by a neurologist will be recruited in this study. Inclusion criteria will be:
Exclusion criteria
will be:
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
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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
Time frame: From enrollment to the end of treatment at 8 weeks
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
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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. Stride length (cm) will be recorded for analysis
Time frame: From enrollment to the end of treatment at 8 weeks
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. Cadence (steps/min) will be recorded for analysis
Alvaro Reyes
Other
Enhancing Self-Efficacy in Individuals With Parkinson's Disease Through Dual Task Training: Effects of Task Modality, Attentional Prioritization, and Cognitive Status
Acronym: DEEP-PD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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