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临床试验/NCT02419768
NCT02419768Unknown不适用

Locomotion of Parkinsonian Patient: Are There Relations Between the Long Range Autocorrelations and the Neurological Impairments, Walking Abilities and the Practice of Physical Exercise?

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Balance Evaluation Systems Test (BESTest)

研究概览

简要总结

Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The parkinsonian gait is characterized by reducted stride length and gait speed, postural disorders (with a high risk of falling) and a modification of stride duration variability. This variability can be assessed by its magnitude (SD and CV) and its temporal organization (long-range autocorrelations). Healthy human gait presents with an interdependency between consecutive cycles that can span over hundreds of strides (long-range autocorrelations). Numerous observations plead for a relation between long-range autocorrelations and functional abilities of the system. Complementary to drugs, rehabilitation becomes an important way to treat PD.

The aim of our study is to assess by a controlled, randomized, single blinded clinical study, the effect of physical exercise on stride duration variability, neurological impairments and walking abilities of parkinsonian patients.

Physical exercise program will include 30 sessions spread over 15 weeks following the guidelines. Long-range correlations analysis, including the study of Hurst and α exponents, will be performed on a minimum of 512 consecutive cycles. Finally, the functional assessment of the parkinsonian patient will be done according to International Classification of Functioning Disability and Health (ICF).

详细描述

BACKGROUND

One of the most common features of human movement is its variability across multiple repetition of the same rhythmic task (1). In humans, many periodic signals, such as gait, heartbeat, respiratory and neuronal activities are characterized by their temporal complexity, fluctuating in a complex manner over time. Although fluctuations between cycles could appear to vary randomly, without apparent correlations between cycles, healthy systems possess the memory of preceding values of the series displaying a complex temporal structure.

In order to assess variability in physiological time series, several mathematical methods can be used. On one hand, classical mathematical methods, usually applied on shorter time series (tens of data points), quantify the fluctuation magnitude in a set of values independently of their order in the distribution, by computing the standard deviation (SD) and the coefficient of variation (CV). On the other hand, more complex mathematical methods, applied on longer time series (≥512 cycles), can be used to assess the fluctuation dynamics over time (3). These latter methods have demonstrated that variability of numerous physiological signals (cardiac and respiratory rhythm or locomotor activities e.g.) exhibit long-range autocorrelations, whereby the statistical inter-dependency between cycles spans of a very large number of cycles (14).

This temporal organization of variability is thus an intrinsic property within numerous biological systems. Moreover, it could provide insight into the neurophysiological organization and into the regulation of these systems (32). Recent studies claimed that these fluctuations, included in an optimal range, would represent the underlying physiologic capability to make flexible adaptations to everyday stresses placed on the human body (32). Therefore, the presence of such temporal dynamics is thought to be a critical marker of health and their breakdown as an index of pathological condition (18, 25, 32). In human heart rate for instance, deviations from an optimum of variability in either the direction of randomness (atrial fibrillation e.g.) or the over-regularity (congestive heart failure e.g.) indicate the loss of the adaptive capabilities of the system (9, 32).

Alongside, some central nervous system diseases influence the variability, especially, of gait. Indeed, neurodegenerative disorders such as Parkinson and Huntington diseases are characterized, among others, by a modification of walking variability (observed by a breakdown of long-range autocorrelations) and a high risk of falling. Although the origin of long-range autocorrelation remains unknown, their breakdown in such diseases suggests a central control mechanism (8, 11, 13, 16, 17, 36).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis idiopathic Parkinson according to the Brain Bank criteria of the United Kingdom Parkinson's Disease Society
  • Disease severity according to modified Hoehn & Yahr stages I to IV
  • Absence of dementia Minimal Mini Mental State Examination score of 24 or higher
  • Stable drug usage in the last 4 weeks
  • Adequate vision and hearing, achieved using corrective lenses and/or hearing aid if required

排除标准

  • Severe co-morbidity, other neurological problems, acute medical problems (e.g. MI, diabetes) and joint problems affecting mobility
  • Unpredictable "Off"-periods (score >2, MDS-UPDRS item 4.5)

结局指标

主要结局

Balance Evaluation Systems Test (BESTest)

时间窗: Change from baseline in balance measures at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4)

次要结局

  • Six Minute Walk Distance (6-MWD)(Change from baseline in exercise tolerance at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))
  • Impact on Participation and Autonomy Questionnaire (IPAQ)(Change from baseline in participation and quality of life at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))
  • Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)(Change from baseline in MDS-UPDRS at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))
  • 10 Meter Walk Test (10-MWT)(Change from baseline in walking speed, step lenght and cadence at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))
  • Long-range autocorrelations(Change from baseline in long-range autocorrelations at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))
  • Instrumented gait analysis(Change from baseline in gait parameters (kinematic, kinetic, electromyographic and energetic) at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))
  • Activities-specific Balance Confidence Scale (ABC-Scale)(Change from baseline in subjective balance measures (fear of falling) at an expected average of 15 (T1), 30 (T2), 45 (T3) and 60 weeks (T4))

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lejeune

Professor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (2)

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