Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Six minute walk test (6MWT) at the 3 month follow up visit
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will be blinded to group allocation
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control
Participants will perform walking practice on a treadmill and overground without the use of a metronome.
干预措施: Gait training without rhythmic auditory cues (Other)
Targeted Rhythmic Auditory Cueing (TRAC)
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).
干预措施: TRAC (Other)
Distorted Targeted Rhythmic Auditory Cueing (dTRAC)
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).
干预措施: dTRAC (Other)
结局指标
主要结局
Change in Six minute walk test (6MWT) at the 3 month follow up visit
时间窗: Baseline, 3 month follow-up
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.
次要结局
- Hippocampal volume(up to 4 weeks)
- Walking stride length(up to 3 month follow-up)
- Walking Cadence(up to 3 month follow-up)
- Gait interruption index(up to 3 month follow-up)
- Fractional anisotropy(up to 4 weeks)
- Change in Six minute walk test (6MWT) after 4 weeks of training(baseline, 4 weeks)
- Freezing of Gait Questionnaire score(up to 3 month follow-up)
- Mini BESTest (Balance Evaluation Systems Test) score(up to 3 month follow-up)