About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Gait training without rhythmic auditory cues
Other interventionGait training on treadmill and overground without any rhythmic auditory cues
TRAC
Other interventionMetronome set to 85% on treadmill and 115% when walking overground
dTRAC
Other interventionMetronome set around 85% on treadmill and around 115% when walking overground
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator