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临床试验/NCT05790759
NCT05790759已完成不适用

Effect of Rhythmic Haptic Stimulations on Long-Range Autocorrelations in Parkinson's Disease Gait Variability : A Comparison With Auditory Stimulations

Cliniques universitaires Saint-Luc- Université Catholique de Louvain4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年1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
入组人数
10
试验地点
4
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 the temporal organization of stride duration variability (reduced Long-Range Autocorrelations (LRA)). For years, auditory cueing has been used to modulate PD gait and its effect on LRA is known. Less is known regarding the effects of haptic cueing on PD gait and especially on LRA. This pilot study will compare the spatio-temporal gait parameters and LRA of PD patients tested under three conditions: walking without cueing, walking with auditory cueing and walking with haptic cueing by means of rhythmic vibrations on the patients' wrists.

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 at least 256 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, and adaptation strategies such as the use of rhythmic sensory cueing. Auditory Cueing (AC) has been used for years for clinical and research purposes and its effects on spatio-temporal gait parameters and LRA are known. Less is know regarding Haptic/Somatosensory Cueing (HC). A few research were conducted to study the influence of HC on PD spatio-temporal gait parameters but to the best of our knowledge, none has yet addressed its effects on LRA. The aim of this present study was to compare PD saptio-temporal gait parameters and LRA under three conditions : walking without cueing, walking with AC and walking with HC. 2. METHODS 2.1 Participants : 10 patients suffering from idiopathic Parkinson's Disease were 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).

2.2 Functional assessment: Before the expermientations starts, all participants underwent a non harmful assessment including clinical tests and questionnaires

PD patients: Age, height, weight, sex, most affected side, Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS), Mini Balance Evaluation Systems Test (Mini-BESTest), Simplified version of the Activities-specific Balance Confidence Scale (ABC-Scale), modified Hoehn & Yahr scale, Mini Mental State Examination (MMSE).

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

  • Idiopathic PD according to the UK Brain Bank Criteria
  • modified Hoehn & Yahr scale <= 3
  • Mini-Mental State Examination > 24/30
  • Ability to walk 256 consecutive strides

排除标准

  • Other pathology interacting with gait
  • Significant hearing problems not allowing to hear the auditory cueing
  • Significant somatosensory problems not allowing to feel the haptic cueing on the skin

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 computation using the evenly spaced version of the Detrended Fluctuations Analysis

次要结局

  • 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))
  • 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))

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 (4)

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