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临床试验/NCT06859229
NCT06859229尚未招募不适用

Effects on Gait Patterns of a New Technological Pathway for Gait Rehabilitation in Patients with Movement Disorders

IRCCS Centro Neurolesi Bonino Pulejo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Neural correlates of movement

研究概览

简要总结

**Brief Summary**

The study aims to explore how the integration of visual and motor systems can be trained and enhanced to improve gait rehabilitation in patients with various neurological and cardiovascular conditions. Scientific evidence highlights that physical activity requires coordination and precise processing of visual, auditory, and sensory information from the external environment, which is then integrated at the brain level. This process establishes synaptic connections that direct the movement of arms, hands, legs, and the trunk through bottom-up and top-down mechanisms. However, inaccurate or incomplete perceptual information can impair performance, even when accurate visual stimuli are provided, emphasizing the importance of assessing and enhancing visuo-motor integration.

The research investigates the central mechanisms controlling peripheral muscle activation patterns during gait. While over-ground walking in healthy individuals generally does not activate the prefrontal cortex except in dual-task scenarios, evidence suggests that post-stroke patients exhibit increased prefrontal cortex metabolism during walking. Recent studies have shown that gait training with exoskeletal systems improves walking patterns in post-stroke patients by altering muscle activation patterns and increasing fronto-parietal connectivity.

This study seeks to answer the following question: How do central and peripheral mechanisms interact to influence gait rehabilitation outcomes, and what role do visuo-motor integration and neuroplasticity play in this process? To address this, advanced neuroimaging technologies such as fMRI, dtMRI, and NIRS will be employed to investigate these mechanisms in vivo.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with a Montreal Cognitive Assessment (MoCA) score, corrected for age and education, equal to or greater than
  • •Subjects capable of walking independently (Functional Ambulation Categories - FAC > 2).

排除标准

  • •Cognitive impairments that compromise the understanding and/or execution of the proposed exercises.
  • •Associated comorbidities that prevent maintaining an upright position or walking (e.g., hypotension).
  • •Refusal or inability to provide informed consent.
  • •Patients with contraindications to the use of the technological equipment required for the dynamic movement pathway.

研究组 & 干预措施

Innovative gait rehabilitation pathway

Experimental

The group will be treated with a dynamic pathway with advanced technology for gait rehabilitation.

干预措施: Innovative technology pathway for gait neurorehabilitation (Device)

Conventional gait rehabilitation

Active Comparator

The group will be treated with conventional gait rehabilitation strategies.

干预措施: Conventional gait rehabilitation strategy (Other)

结局指标

主要结局

Neural correlates of movement

时间窗: From enrollment to end of treatment at five weeks

We will assess motor functions using clinical scales (e.g., Fugl-Meyer Lower Extremity), to explore potential links between gait rehabilitation and motor recovery. Time Frame: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).

次要结局

  • Neurophysiological outcome(From enrollment to end of treatment at five weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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