Cognitive-motor Training for PD

NCT ID: NCT01917903

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-26

Study Completion Date

2022-12-15

Brief Summary

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This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously. By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD. Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty. Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention. The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.

Detailed Description

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In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone. Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking. During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into two training groups and asked to come to the lab three times a week for four weeks during the intervention. One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit. The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Assessments are performed by a clinician blinded to participant group (training vs. waitlist control) allocation.

Study Groups

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Identification of at risk variables

Individuals will come in for a single visit to perform all tasks / conditions. Measurements will be taken of spatial and temporal features of walking with and without a secondary task. In addition, cognitive tests of memory and attention will be performed. Outcomes will narrow measures to those most likely to show clinically significant change.

Group Type EXPERIMENTAL

Identification of at risk variables

Intervention Type BEHAVIORAL

Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive). Spatiotemporal measures of gait will be collected.

Gait-Cognitive training

Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.

Group Type EXPERIMENTAL

Gait-cognitive training

Intervention Type BEHAVIORAL

Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.

Interventions

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Gait-cognitive training

Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.

Intervention Type BEHAVIORAL

Identification of at risk variables

Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive). Spatiotemporal measures of gait will be collected.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Parkinson's disease with our without cognitive impairment
* ambulatory for at least 200 feet without an assistive device (cane, walker, etc)

Exclusion Criteria

* recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
* concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
* cardiac insufficiency limiting ability to participate in walking study
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Lisa Muratori

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa M Muratori

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University RRAMP Laboratory

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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64249

Identifier Type: -

Identifier Source: org_study_id

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