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临床试验/NCT02231073
NCT02231073已完成不适用

Peripheral and Central Postural Disorders in the Elderly

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Change in Mini-BESTest score

研究概览

简要总结

There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. People with Parkinson's disease have important changes in cognitive function that may impact rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson's disease and play a role in rehabilitation efficacy. The purpose of this study is to 1) determine if people with Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation.

Design: This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory. The study participants will be people with Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6 weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD. The education program is a 6-week program to teach people how to better live with a chronic disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility, cognition and neural imaging.

Discussion: The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Mini-BESTest score

时间窗: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

The Mini-BESTest assesses dynamic balance via a 14-item test that measures multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait.

次要结局

  • Change in MDS-UPDRS score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in New Freezing of Gait questionnaire (NFOGQ) score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in Activities of Balance Confidence (ABC) questionnaire score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in instrumented gait and balance measures(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in Cognitive measures(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in PDQ-39 score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Neural Imaging(Baseline)

研究者

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

Fay B. Horak

Professor

Oregon Health and Science University

研究点 (2)

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