Cognitive-motor Training for PD

NCT01917903 | Unknown

• 1 other identifier: 64249
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

walking; Parkinson's disease; physical therapy; falls; memory; attention; multitasking; exercise

Outcome Measures

Primary Outcomes (1)

• Spatiotemporal measures of gait across conditions and over time.

  Changes in gait parameters are a key measure of the difficulty of performing two tasks at once. Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.

  Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)

Secondary Outcomes (1)

• Changes in cognitive performance measured with serial sevens.

  Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)

Study Arms (2)

Identification of at risk variables

EXPERIMENTAL

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.

Behavioral: Identification of at risk variables

Gait-Cognitive training

EXPERIMENTAL

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

Behavioral: Gait-cognitive training

Interventions

Gait-cognitive training BEHAVIORAL

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

Gait-Cognitive training

Identification of at risk variables 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.

Identification of at risk variables

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University RRAMP Laboratory

Stony Brook, New York, 11794-6018, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Lisa M Muratori

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Assessments are performed by a clinician blinded to participant group (training vs. waitlist control) allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 7, 2013
• Study Start: October 26, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 15, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

US (1)