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临床试验/NCT04019158
NCT04019158已完成不适用

Immersive Virtual Reality on Treadmill to Ecologically Assess Parkinson's Disease Patients' Gait

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月10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
入组人数
10
试验地点
2
主要终点
Long-Range Autocorrelations

研究概览

简要总结

Parkinson's Disease (PD) patients suffer from gait impairments responsible for falls and bad quality of life: reduced speed and stride length, randomness in stride duration variability (reduced Long-Range Autocorrelations (LRA)). This pilot study will compare the spatio-temporal walking parameters and LRA of PD patients tested under three conditions: walking over ground, walking on a treadmill and walking on a treadmill in virtual reality. The aim is to determine the effect on gait of an optical flow recreated in virtual reality, by means of a virtual reality headset, on a treadmill.

详细描述

  1. BACKGROUND Parkinson's disease (PD) is the second most common degenerative neurological disease. PD induces gait disorders that lead to increased risk of falls. These falls seriously affect patients' quality of life and generate significant health care costs. Unfortunately, gait disorders do not respond well to drug treatments and their management is mainly based on rehabilitation treatment. The rehabilitation approach comprises two steps: a functional assessment of locomotor capacities followed by completion of a therapeutic physical exercise program.

Like heart rate, stride duration varies in the short and long term according to a complex dynamic of temporal variations. These variations present long-range autocorrelations (LRA): the stride duration does not vary randomly but in a structured way. The study of LRA is based on complex mathematical methods requiring recording of 512 consecutive gait cycles. LRA are altered in PD patients whose gait rhythm is excessively random. Alteration of LRA is correlated with neurological impairments (Hoehn & Yahr scale and UPDRS) and patients' locomotor stability (ABC scale & BESTest). Measurement of LRA would be the first available objective and quantitative biomarker of stability and risk of falling in patients with PD.

Guidelines concerning rehabilitation programs for PD patients are based on education (prevention of falls and inactivity,...), physical exercises, functional training (double task, complex tasks,...), learning, adaptation strategies (cueing) and action observation. The combination between immersive virtual reality (iVR), using an iVR headset, and treadmill walking will be developped.

Treadmill walking has shown long-term effectiveness on PD patients' gait and quality of life. A study carried out recently has shown that a single treadmill session reduces the stride duration variability during the intervention. Although the treadmill seems to improve patients' gait, it lacks an essential ecological component that allows humans to stabilize gait: an optical flow, an environment that scrolls during walking. iVR allows to give patients a visual flow when walking on treadmill as if they were walking overground and patients could benefit from it. The purpose of this pilot study is to compare the spatio-temporal gait parameters and gait variability parameters obtained during three Walking conditions: over ground walking, treadmill walking, treadmill walking with a VR headset. 2. METHODS

2.1 Participants : 10 patients suffering from idiopathic Parkinson's Disease will be recruited from the local community and from the Neurology and the Physical and Rehabilitation Medicine outpatient clinics of the Cliniques universitaires Saint-Luc (Woluwe-Saint-Lambert, Belgium).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • PD patients:
  • idiopathic PD diagnosis made by an experienced neurologist according to United Kingdom Brain Bank criteria
  • mild to moderate motor disorders according to modified Hoehn & Yahr scale (stages I-III)
  • ability to walk for a minimum of 512 gait cycles (±15 minutes) in a row without walking aids
  • no other pathology interacting with gait or provoking dizziness
  • no uncorrected vision disorders
  • a minimum of 24/30 on the Mini-Mental State Examination (MMSE)

排除标准

  • PD Patients:
  • other neurological or orthopedic pathologies that could interact with their motor capacities and gait performance
  • pathology that could provoke vertigo or nausea
  • uncorrected vision disorders
  • contraindications to physical exercise

结局指标

主要结局

Long-Range Autocorrelations

时间窗: Change from baseline in long-range autocorrelations during each intervention condition (3 x 10 min walking)

Long-Range Autocorrelations

次要结局

  • Gait cadence(Change from baseline in gait cadence during each intervention condition (3 x 10 min walking))
  • Coefficient of variation of stride duration(Change from baseline in coefficient of variation during each intervention condition (3 x 10 min walking))
  • Simulator Sickness Questionnaire (SSQ)(Change from baseline in SSQ after the VRW condition)
  • Mean gait speed(Change from baseline in mean gait speed during each intervention condition (3 x 10 min walking))
  • Step length(Change from baseline in step length during each intervention condition (3 x 10 min walking))

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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