跳至主要内容
临床试验/NCT03727529
NCT03727529Unknown不适用

Use of Immersive Virtual Reality on Treadmill to Improve Gait in Parkinson's Disease: a Single Blinded, Randomized Controlled Trial

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
46
试验地点
2
主要终点
Long-Range Autocorrelations: H exponent

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)). On the other hand, treadmill walking has shown long-term effectiveness on PD patients' gait and quality of life. The purpose of this single blinded randomized controlled trial is to study the effect of a combination of immersive virtual reality and treadmill walking on LRA.

详细描述

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) 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. There remains then to determine the long-term effect of this rehabilitation method on LRA, apart from the intervention, when walking overground. Combining iVR with treadmill walking rehabilitation offers interesting insights. Indeed, for stroke patients, this combination is more effective than classical techniques. For PD patients, non-immersive virtual reality methods (Wii, Kinect) have shown relative efficacy. Indeed, the use of non-immersive virtual reality on treadmill induces more efficient cognitive engagement and frontal lobe activation among PD patients. Non immersive VR gives longer-term effects and a greater decrease in the number of falls than without virtual reality. Furthermore, iVR makes it possible to give a functional character to reeducation and to enrich feedbacks. Indeed, iVR allows to give patients a visual flow when walking on treadmill as if they were walking overground and patients could benefit from it. But apart from a feasibility study, the therapeutic interest of iVR has not been studied yet for PD patients, especially iVR combined with treadmill walking. iVR is now easily accessible and its price is reduced, suggesting a potential for everyday clinical practice. Indeed, these new devices of good quality seem to have a good potential for neurorehabilitation. The purpose of this single blinded randomized controlled trial is then to study the effect of a comibination of immersive virtual reality and treadmill walking on LRA.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Parkinson's Disease diagnosis made according to UK Brain Bank criteria
  • Hoehn and Yahr score of 1 to 3 (physically independent, able to walk unassisted)
  • Optimal drug treatment for at least 4 weeks at the time of inclusion
  • In ON phase during assessments and treatment sessions

排除标准

  • Other pathologies that increase risk of falling
  • Other pathologies that increase risk of nausea and vertigo
  • Contraindication to physical exercising (ACSM criteria)
  • Freezing of gait

研究组 & 干预措施

Intervention group

Experimental

干预措施: Treadmill + VR (Other)

Control group

Active Comparator

干预措施: Treadmill (Other)

结局指标

主要结局

Long-Range Autocorrelations: H exponent

时间窗: Change from baseline in H exponent at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

First, stride duration will be assessed using accelerometers. After this, temporal varibility of stride duration will be assessed using the Rescaled Range Analysis (H exponent) to get the Long Range Autocorrelations.

Long-Range Autocorrelations: Alpha exponent

时间窗: Change from baseline in Alpha exponent at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks

First, stride duration will be assessed using accelerometers. After this, temporal varibility of stride duration will be assessed using the Power Spectral Density (Alpha exponent) to get the Long Range Autocorrelations.

次要结局

  • Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)(Change from baseline in MDS-UPDRS at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • 2 minutes walk distance(Change from baseline in 2 minutes walk distance at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Gait cadence(Change from baseline in gait cadence at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Step length(Change from baseline in step length at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Coefficient of variation of stride duration(Change from baseline in coefficient of variation at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Mean gait speed(Change from baseline in mean gait speed at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Simplified version of the Activities-specific Balance Confidence Scale (ABC-Scale)(Change from baseline in ABC-Scale at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Balance Evaluation Systems Test (BESTest)(Change from baseline in BESTest at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • Fall diary(Change from baseline in number of falls at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)
  • The 39-items Parkinson's Disease Questionnaire (PDQ-39)(Change from baseline in PDQ-39 at an expected average of 6 (T1), 18 (T2) and 30 (T3) weeks)

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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