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临床试验/NCT05906875
NCT05906875已完成不适用

A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Feasibility Study

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
The Four-Square Step Test

研究概览

简要总结

The purpose of this exploratory single-blinded feasibility study is to explore the effects of a lateral stepping program integrated into an existing community-based group exercise program for people with PD. The researchers hypothesize that participation in a lateral stepping program a minimum of 2 times/week for 8 weeks, in addition to RSB class participation is feasible in middle to late stage PD and will decrease fall risk factors. The researchers also hypothesize that the integration of this program into an existing community-based RSB program will be deemed feasible as shown by the number of sessions attended by each participant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of idiopathic PD stages II, III, or IV of the Hoehn and Yahr scale
  • 50-85 years inclusive
  • Subjects must be enrolled in RSB at NY Tech and attend at least 1 day per week for a minimum of 4 weeks prior to the first baseline assessment
  • English speaking.
  • Stable PD medication regime.

排除标准

  • Any cardiovascular or other medical condition that would affect participation
  • Any hip and/or knee surgery or other injury that would prevent full participation in the intervention
  • Neurological conditions other than PD
  • Montreal Cognitive Assessment of ≤21
  • Pain that interferes with testing 13
  • Current participation in other strengthening, stretching or balance programs other than Rock Steady Boxing at NY Tech
  • Inability to understand and fully participate in this study

结局指标

主要结局

The Four-Square Step Test

时间窗: less than 5 minutes

Validated for people with PD is used to measure a patient's fall risk. The test requires a stopwatch and 4 canes laid in a cross pattern. The canes crossed pattern makeup 4 quadrants; quadrant 1 (bottom left), quadrant 2 (top left), quadrant 3 (top right), and quadrant 4 (bottom right). The subject is timed while they step clockwise, and then counterclockwise throughout the quadrants. An assistive device may be used.

The Activities Balance Confidence Scale

时间窗: 5-10 minutes

Validated for people with PD, is a self-report measure of balance confidence while performing various common activities. Scale is from 0% to 100% with 100% being the most confident in their balance in a criterion.

The Mini-BESTest

时间窗: 10-15 minutes

Performance measure, validated in people with PD, aimed to target and identify 6 different balance control systems

The Functional Gait Assessment

时间窗: 5-20 minutes

Validated for people with PD is a performance measure validated in people with PD that is used to assess balance in the higher-functioning older adult and examines ambulation and the ability to perform motor tasks while ambulating

The Multidirectional Functional Reach Test

时间窗: Less than 5 minutes

Used to assess stability when displacing a person's balance in a forward, lateral, and backward direction

The Parkinson's Disease Questionnaire-39

时间窗: approximately 10 minutes

39-item self-administered questionnaire designed to assess 8 different quality-of-life domains. Uses a 5-point ordinal scale with 0 being never and 5 being always. Lower scores indicate a lower quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Tautonico

Assistant Professor

New York Institute of Technology

研究点 (2)

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