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临床试验/NCT03725215
NCT03725215已完成不适用

Influence of Multiple Ratio Split-belt Treadmill on Gait Asymmetry and Motor Learning in PD Patients With Freezing of Gait

KU Leuven4 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
81
试验地点
4
主要终点
Adaptation to Split/Tied Belt

研究概览

简要总结

Freezing of Gait (FOG) is a disabling symptom common in advanced Parkinson's Disease. FOG is an independent contributor to fall risk and is only partially relieved by medication. Parkinson's patients with FOG are known to have more difficulty with gait adaptation in their day to day environment. Further, asymmetry of gait has been implicated in FOG as these episodes are often elicited during asymmetric tasks such as turning. This study will examine the effect of a single session of split-belt treadmill walking on gait adaptation, gait symmetry and FOG as well as 24 hour retention of these effects.

详细描述

In this proposal, the investigators will investigate whether adapting gait to modulations imposed by a split-belt treadmill, improves walking ability and reduces FOG. The investigators will test the hypothesis that motor adaptation deficits underlie FOG and that these problems are modifiable with training. To address these suppositions, the investigators propose a multi-centric study conducted in two research labs with expertise in split-belt gait analysis and FOG: University of Leuven (KUL) and Christian-Albrechts-University Kiel (CAUK). As freezers have been shown to have more difficulty with consolidation of motor learning, the investigators aim in study I (pilot phase) to first understand which split-belt parameters are optimal for training gait flexibility and lead to consolidated gains in daily walking. For this study, the investigators will recruit 60 freezers and 60 healthy controls, pooled across centers, and manipulate different split-belt conditions in one learning and retention session.

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 (Participant)

入排标准

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

入选标准

  • Diagnosis of Parkinson's Disease as per the UK Parkinson's Disease Society Brain Bank Criteria
  • Classification as a Freezer with the New Freezing of Gait Questionnaire (score > 0)
  • Ability to walk at least 5 min. without any aid
  • Stable anti-parkinsonian medication at least 1 month prior to participation

排除标准

  • Neurologic diseases other than PD
  • Orthopedic injuries that could influence gait and balance
  • Participation in treadmill training more than once a week
  • Cognitive impairment (MMSE<24) or inability to follow test instructions
  • Self-reported DBS-related postural or gait disturbances
  • Cardiovascular risk factors
  • Peripheral neuropathy

结局指标

主要结局

Adaptation to Split/Tied Belt

时间窗: 24 hours after training

Measured with 3D motion analysis system during treadmill walking. Patients will walk for 1.5 minutes on the treadmill that will switch from tied-to-split state and back to tied state.

Gait Asymmetry

时间窗: 24 hours after training

Measured with 3D motion analysis system during straight line overground walking

Freezing Ratio

时间窗: 24 hours after training

Measured with APDM sensors during 360 degree turns

次要结局

  • Medio-lateral Anticipatory Postural Adjustments(24 hours after training)
  • Gait Speed during dual task walking(24 hours after training)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice Nieuwboer

Senior Professor

KU Leuven

研究点 (4)

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