Cognitive-motor Training for PD

Parkinson's Disease Clinical Trial

Official title:

The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01917903
• Other study ID #: 64249
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2022
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 15, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Stony Brook University RRAMP Laboratory	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in cognitive performance measured with serial sevens.	Participants will count backward by sevens from a digit between 90 and 100. The ability to perform the task will be used as a measure of cognitive trade-off relative to walking performance.	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)