Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864157
• Other study ID #: 23-0021
• Secondary ID: R21HD111833
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Mike Lewek, PT, PhD
• Phone: 919-966-4041
• Email: mlewek[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to determine how training to step with a metronome on both a treadmill, as well as overground, will influence the way that people with Parkinson disease walk. Using metronomes is commonly used in clinics, but the investigators will be using a combination of slow and fast frequencies to alter the way that people walk. The use of a slower frequency metronome on the treadmill is intended to help participants take larger steps. The use of a faster frequency metronome while walking overground is intended to help participants take faster steps.This will take place over 12 training sessions. Each session will be about an hour. It will include some walking tests and pictures of the brain (using MRI) before and after training.

Description:

Some details regarding the metronome frequency are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• idiopathic Parkinson's disease (Hoehn and Yahr Stage 2-3)

• self-report the ability to walk uninterrupted for 10 minutes both overground and on a treadmill without therapist assistance

• comfortable gait speed > 0.4 m/s and < 1.2 m/s

• normal (or corrected to normal [i.e., hearing aid]) hearing

• deficits in gait continuity (e.g., shuffling, shortened strides, freezing, festination, bradykinesia, etc) based on observational gait analysis

• Movement Disorders Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS-III) item 10 =1 and <3

• be on stable doses of orally-administered levodopa

• age 50-80 years old

Exclusion Criteria:

• contraindications to MRI (e.g., metal implants, claustrophobia, etc)

• cognitive deficits (Montreal Cognitive Assessment [MoCA] < 26)

• concurrent Physical Therapy

• have undergone deep brain stimulation surgery

• cannot walk without therapist assistance

• uncontrolled cardiorespiratory/metabolic disease, or other neurological disorders or orthopedic injury that may affect gait.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Gait training without rhythmic auditory cues
Gait training on treadmill and overground without any rhythmic auditory cues
• TRAC
Metronome set to 85% on treadmill and 115% when walking overground
• dTRAC
Metronome set around 85% on treadmill and around 115% when walking overground

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Six minute walk test (6MWT) at the 3 month follow up visit	The 6-minute walk test provides a more objective quantitative measure of mobility, functional performance, and symptom control. It measures the distance an individual can walk over a total of six minutes on a hard, flat surface. The individual can self-pace and rest as needed as they walk back and forth along a marked course. The participant can use an assistive walking device they normally use, such as a cane. The minimum clinically important difference in 6-minute walk distance is approximately 30 meters, a difference that is associated with mortality. A higher change score represents a greater improvement in walking function and a better outcome.	Baseline, 3 month follow-up
Secondary	Change in Six minute walk test (6MWT) after 4 weeks of training	The 6-minute walk test provides a more objective quantitative measure of mobility, functional performance, and symptom control. It measures the distance an individual can walk over a total of six minutes on a hard, flat surface. The individual can self-pace and rest as needed as they walk back and forth along a marked course. The participant can use an assistive walking device they normally use, such as a cane. The minimum clinically important difference in 6-minute walk distance is approximately 30 meters, a difference that is associated with mortality. A higher change score represents a greater improvement in walking function and a better outcome.	baseline, 4 weeks
Secondary	Walking stride length	The walking stride length represents the average stride length (distance between where one foot strikes the ground to the location that the same foot strikes the ground to complete the stride). The distance is measured from walking over a pressure mat during the 6MWT. This measurement will be completed at baseline (prior to training), after 4 weeks of training, and again for a 3 month follow-up. A larger value represents longer steps, and a better outcome.	up to 3 month follow-up
Secondary	Walking Cadence	Walking cadence is the frequency of steps per minute (inverse of step time). The average cadence is measured from passes over a pressure mat during the 6MWT, and will be completed at baseline (prior to training), after 4 weeks of training, and again for a 3 month follow-up.	up to 3 month follow-up
Secondary	Gait interruption index	The Gait Interruption Index represents the number of 'freezes' observed, divided by the number of 'freeze opportunities' (i.e., turns, times stepping on/off pressure mat) completed during the 6MWT. A higher number represents greater impairment in Freezing of Gait. This measurement will be completed at baseline (prior to training), after 4 weeks of training, and again for a 3 month follow-up.	up to 3 month follow-up
Secondary	Mini BESTest (Balance Evaluation Systems Test) score	The mini-BESTest is a 14-item, clinical battery used to assess balance in four component areas (anticipatory transitions, postural response, sensory orientation and dynamic gait) and provides a single number summary of balance performance. Scores range from 0 to 28 with higher scores indicate higher function.	up to 3 month follow-up
Secondary	Freezing of Gait Questionnaire score	The Freezing of Gait Questionnaire assesses freezing of gait (FOG) severity unrelated to falls in patients with Parkinson disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. The total score ranges from 0-24, with higher scores representing greater severity of FOG symptoms.	up to 3 month follow-up
Secondary	Hippocampal volume	Hippocampal volume represents the size of the hippocampus, which is a portion of the deep brain. In particular, the investigators will compute the three dimensional volume of the hippocampus from structural MRI (Magnetic Resonance Imaging) taken at baseline and after 4 weeks of training.	up to 4 weeks
Secondary	Fractional anisotropy	Fractional anisotropy (FA) is derived from diffusion tensor imaging (DTI) sequences taken during the neuroimaging testing. FA reflects a ratio of the directional flows of water molecules within axonal bundles.	up to 4 weeks