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临床试验/NCT03253965
NCT03253965已完成不适用

The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Step Length

研究概览

简要总结

The purpose of this study is to determine how using auditory cues of a metronome and music at various frequencies impacts the gait mechanics in people with Parkinson's disease when walking over ground and on a treadmill.

The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired subjects.

Participants will complete 7 different treadmill walking conditions and overground walking conditions while the investigators measure step length, cadence, gait speed, and variability of movement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •10 unimpaired controls and 30 subjects with Parkinson's Disease (described in detail below - see inclusion/

排除标准

  • •). The 30 subjects with Parkinson's Disease will be assigned into 3 groups (10 with H&Y Stage 1, 10 with H&Y Stage 2, and 10 with H&Y Stage 3).
  • •Inclusion Criteria:
  • •Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk >10 m overground as well as walk on a treadmill for a total of 14 minutes with rest breaks as needed, and be classified as Stage 1, 2, or 3 on the Hoehn and Yahr Scale since these stages have the most independence with mobility (Goetz et. al, 2004).
  • •Exclusion Criteria:
  • •Exclusion criteria include Hoehn and Yahr Stage 4 and 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.

研究组 & 干预措施

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Metronome Normal (Other)

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Metronome Slow (Other)

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Metronome Fast (Other)

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Music Normal (Other)

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Music Slow (Other)

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Music Fast (Other)

Walking: Treadmill then Overground

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: No Auditory cueing (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Metronome Normal (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Metronome Slow (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Metronome Fast (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Music Normal (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Music Slow (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: Music Fast (Other)

Walking: Overground, then Treadmill

Experimental

Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.

干预措施: No Auditory cueing (Other)

结局指标

主要结局

Step Length

时间窗: The entire duration of each condition, approximately 2 minutes each.

The length of each step taken while walking on a treadmill or overground. It is the anteroposterior distance from one foot to the other at heel strike measured during walking under each condition.

次要结局

  • Gait speed(The entire duration of each condition, approximately 2 minutes each.)
  • Cadence(The entire duration of each condition, approximately 2 minutes each.)
  • Movement variability(The entire duration of each condition, approximately 2 minutes each.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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