Back to resultsTargeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait training without rhythmic auditory cues
TRAC
dTRAC
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Gait, Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Targeted Rhythmic Auditory Cueing (TRAC)
Distorted Targeted Rhythmic Auditory Cueing (dTRAC)
Arm Description
Participants will perform walking practice on a treadmill and overground without the use of a metronome.
Participants will perform walking practice on a treadmill (with a metronome set to 85% of typical cadence) and overground (with a metronome set to 115% of typical cadence).
Participants will perform walking practice on a treadmill (with a metronome set around 85% of typical cadence) and overground (with a metronome set around 115% of typical cadence).
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05864157
First Posted
May 8, 2023
Last Updated
October 3, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05864157
Brief Title
Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Official Title
Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Gait, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to group allocation
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will perform walking practice on a treadmill and overground without the use of a metronome.
Arm Title
Targeted Rhythmic Auditory Cueing (TRAC)
Arm Type
Experimental
Arm Description
Participants will perform walking practice on a treadmill (with a metronome set to 85% of typical cadence) and overground (with a metronome set to 115% of typical cadence).
Arm Title
Distorted Targeted Rhythmic Auditory Cueing (dTRAC)
Arm Type
Experimental
Arm Description
Participants will perform walking practice on a treadmill (with a metronome set around 85% of typical cadence) and overground (with a metronome set around 115% of typical cadence).
Intervention Type
Other
Intervention Name(s)
Gait training without rhythmic auditory cues
Intervention Description
Gait training on treadmill and overground without any rhythmic auditory cues
Intervention Type
Other
Intervention Name(s)
TRAC
Intervention Description
Metronome set to 85% on treadmill and 115% when walking overground
Intervention Type
Other
Intervention Name(s)
dTRAC
Intervention Description
Metronome set around 85% on treadmill and around 115% when walking overground
Primary Outcome Measure Information:
Title
Change in Six minute walk test (6MWT) at the 3 month follow up visit
Description
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.
Time Frame
Baseline, 3 month follow-up
Secondary Outcome Measure Information:
Title
Change in Six minute walk test (6MWT) after 4 weeks of training
Description
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.
Time Frame
baseline, 4 weeks
Title
Walking stride length
Description
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.
Time Frame
up to 3 month follow-up
Title
Walking Cadence
Description
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.
Time Frame
up to 3 month follow-up
Title
Gait interruption index
Description
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.
Time Frame
up to 3 month follow-up
Title
Mini BESTest (Balance Evaluation Systems Test) score
Description
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.
Time Frame
up to 3 month follow-up
Title
Freezing of Gait Questionnaire score
Description
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.
Time Frame
up to 3 month follow-up
Title
Hippocampal volume
Description
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.
Time Frame
up to 4 weeks
Title
Fractional anisotropy
Description
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.
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Lewek, PT, PhD
Phone
919-966-4041
Email
mlewek@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Lewek, PT, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lewek, PT, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All data collected will be shared with other researchers. Specifically, the investigators will share all individual level 6MWT distances, average cadence, stride length, and gait interruption indices from the baseline test, after 4 weeks of training, and at the 3 month follow-up. All MiniBESTtest total scores, and FOGQ total scores from these timepoints will also be shared for each individual. Finally, the investigators will share hippocampal volume and fractional anisotropy values from each participant taken at baseline and after four weeks of training.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Moreover, the investigators are committed to releasing all data, including neuroimaging, and scale data to the general scientific community, upon completion of the study. In particular, the investigators will use open platforms (e.g., UNC Dataverse) to disseminate data. Access to the data repository will be free of charge.
Learn more about this trial
Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
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