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临床试验/NCT01413321
NCT01413321已完成不适用

The Reproducibility and Special Features of Hemiparetic Gait in People With Acquired Brain Injury (ABI) Assessed With an Instrumented Treadmill (Zebris)

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Quality of walking assessed by spatio-temporal gait parameters commonly used in gait laboratories.

研究概览

简要总结

Hemiparetic gait following acquired brain injury (ABI) is grossly characterized by decreased speed of walking, increased stance time on the unaffected side, and decreased stance time on the affected side.These abnormalities are associated with a complex pattern of dysfunction including muscle weakness, spasticity, impaired sensory-motor control, long-term mechanical changes in muscles and joints, and cognitive impairments e.g. attention.\ At this stage of our knowledge it is still unclear which kinetic and kinematic parameters of hemiparetic gait provide insight about the different components of the complex pattern of dysfunction.

A novel technique had been introduced in the Motion Laboratory of the Sheba Medical Center consisting of an ordinary treadmill that is equipped with a 'mat' of more than 5000 high-quality capacitive pressure/force sensors. This treadmill developed by "ZEBRIS" enables to analyze gait and roll-off patterns on the treadmill.

Aims of the study:

  1. To assess variability of data derived from the Zebris treadmill.
  2. To investigate stability of hemiparetic gait.
  3. To evaluate variability and relevant gait parameters taking place during recovery after acute ABI.
  4. To compare gait on ground with gait on treadmill.

Rationale of the study- Basic assumptions of the study:

  1. No significant change in gait parameters is expected in both groups including healthy controls and chronic ABI subjects in recurrent examination within one week period.
  2. Subacute ABI patients are found to be within the context of neurorehabilitative recovery due to brain plasticity. Therefore a change in gait parameters is expected within two consecutive examinations in the chosen time intervals.
  3. All measurements are subject to error which contributes to the variance of outcomes.

On the grounds of these assumptions:

A. Two consecutive examinations in both groups including healthy controls and chronic ABI subjects are intended to estimate the error in measured values.

B. Two consecutive examinations in the subacute ABI patient group are intended to estimate the contribution of neurorehabilitative recovery due to brain plasticity assessed with this unique research instrumentation.

详细描述

Introduction The term hemiplegia/hemiparesis is used for the neural deficit that may occur in patients after acquired brain injury (ABI), such as cerebral palsy, traumatic injury to the brain, or cerebrovascular accident. The word hemiplegia means the neuromuscular disorder that involves one-half of the body in the frontal plane while the other half is not involved.

Hemiparetic gait following ABI is grossly characterized by decreased speed of walking, increased stance time on the unaffected side, and decreased stance time on the affected side. Joint-angle disturbances include reduction or loss of the knee flexion phase in stance, reduction of knee flexion in the swing phase, sometimes loss of dorsiflexion of the ankle in the swing phase and at initial contact, and generally reduced joint excursions. Lehmann et all [1] have reported a greater-than-normal internal knee flexion moment at mid-stance in persons with hemiplegia, a feature that was thought to be related to anterior movement of the center of gravity. ("Internal" moments are expressed as those internal to the link-segment model; "external" moments are expressed as those acting upon the link-segment model.) The internal moment is usually the result of muscle activity, though tension of structures posterior to the knee may also be involved if the knee is fully extended. Patients with hemiplegia exhibit disturbed mechanical energy patterns and overall energy costs that are above normal [2]. The affected limb characteristically has shown tonic extensor activity, co-activation of major muscle groups, and loss of selective muscle control during stance [3]. The patterns of activity and the presence of co-activation during walking have been used to classify the gait of subjects with hemiplegia [4]. Muscle power patterns at major lower-limb joints during walking have been near normal in shape but reduced in amplitude, with the muscles of the affected side providing about 40% of the positive work [5].

These abnormalities are associated with a complex pattern of dysfunction including muscle weakness, spasticity, impaired sensory-motor control and long-term mechanical changes in muscles and joints [4], [6], [7], [8], [9], and cognitive impairments e.g. attention.

At this stage of our knowledge it is still unclear which kinetic and kinematic parameters of hemiparetic gait provide insight about the different components of the complex pattern of dysfunction.

Subjects with hemiparesis will show different reactions to change pattern of the treadmill, like gait velocity and inclination in comparison to healthy subjects. Especially performing the investigation under these challenging conditions may reveal the relevant insight in the contribution of these different components to the complex pattern of hemiparetic gait. Qualitative and quantitative evaluation of gait performed during clinical examination and gait examination in a gait laboratory deliver temporal and spatial parameters. These parameters relate to automatism and symmetry which are the two main components of gait.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18y, both healthy and hemiparetic participants.
  • Able to walk continuously for 6 min at their self-selected speed.
  • Normal subjects should be without any clinical history of diseases or injuries in the lower extremities.
  • Able to understand the eligibility requirements for participation in the study.

排除标准

  • Patients with more than one previous clinical stroke or other brain injury.
  • Peripheral artery disease with claudication.
  • Shortness of breath without exertion
  • Resting heart rate outside of the range of 55 to 85 bpm.
  • Resting blood pressure outside of the range of 90/60 to 170/90 mm Hg.
  • Medical and especially cardial conditions preventing walking for more than 10 minutes under normal velocity.
  • No additional major orthopedic or neuromuscular disorders preventing normal walking.

结局指标

主要结局

Quality of walking assessed by spatio-temporal gait parameters commonly used in gait laboratories.

时间窗: One predetermined gait session should last to 90 minutes. Data collection will be finished one year after the start of the study. Data analysis will be done up to 1 year after Data collection. Summarize of the study 6 months after Data analysis.

Quality of walking: measured by quantifying temporal and spatial parameters, such as \[Length of stance phase, Length of swing phase (swing time), Length of double support phase, time of step, Cadence, Step length, Stride\]. These parameters will be calculated from the ground reaction force in function of time.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Manuel Zwecker MD

Senior physician, Department of Neurological Rehabilitation.

Sheba Medical Center

研究点 (1)

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