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临床试验/NCT04877249
NCT04877249已完成不适用

Gait Training to Reduce Compensatory Walking Patterns in Post-Stroke Hemiparesis

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
Bilateral muscles activities during split-belt treadmill walking

研究概览

简要总结

The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.

详细描述

This study will include twenty stroke survivors and twenty healthy adults (total 40 participants) who are 20 years or older. Both groups (stroke vs healthy) will be screened and recruited from a UTMB Stroke Support Group and local community in Galveston or Harris County for one year (2021-22). Healthy individuals will also participate in gait training compared to stroke participants. The focus of this gait training is to optimize the delivery of a combined strength and aerobic training regimen to older adults with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. Investigators propose to use a combination of neuromechanical and biobehavioral approaches to enhance bilateral symmetry of limb propulsion using specialized split-belt, force-plate instrumented treadmill that uses backward directed resistance forces. With neuromechanics investigators will measure joint torque output, EMG muscle activity patterns, and trailing limb angle, while a person is walking under normal treadmill belt conditions versus the split-belt conditions at different levels of resistance. Electromyography (EMG) detects electrical activity during muscle contraction while the single or the split-belt treadmill walking. The joint torque output and trailing limb angle can be obtained by using the Vicon Motion System (Vicon, Oxford, UK) in conjunction with the Bertec split-belt, force plates instrumented treadmill (Bertec Corp., Columbus, OH). In addition, in terms of biobehavioral metrics, investigators will measure the extent to which people maintain improved paretic limb propulsion contributions immediately after the split-belt environment is restored to a single belt condition (i.e. aftereffects), and the ability of individuals to consciously alter their walking pattern so as to reduce compensatory walking patterns when they are not engaged with the specialized treadmill setup.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy individuals, ages 20 or older
  • •Healthy participants will be required to be medically stable
  • •Healthy participants are able to walk at least 10 meters independently at a comfortable speed without an assistive device
  • •The participants with a history stroke, ages 20 or older
  • •Unilateral first stroke of ischemic origin in the carotid artery distribution
  • •Unilateral first stroke of hemorrhagic origin in the carotid artery distribution
  • •Diagnosis of stroke at least 6 months prior to participation
  • •Free of major post-stroke complications (e.g., recurrent stroke, hip fracture, myocardial infarction)
  • •Living within the community
  • •The participants with a history stroke are able to ambulate 10 meters with or without assistive devices

排除标准

  • •A history of any significant orthopedic problems
  • •A history of psychiatric or cognitive illness (e.g., bipolar affective disorder, psychosis, schizophrenia, attention deficits, cognitive deficits, or medication refractor depression)
  • •Neurological problems
  • •Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke
  • •Not expected to live more than one year
  • •Unable to follow 3 step commands
  • •Amputation
  • •Poorly controlled diabetes (e.g., foot ulceration)
  • •Progressive neurological diseases
  • •Comprehensive aphasia
  • •Medical instability
  • •Significant musculoskeletal problems
  • •Congestive cardiac failure
  • •Unstable angina
  • •Peripheral vascular disease
  • •Neuropsychiatric disorders (e.g., dementia, cognitive deficits, and severe depression)

研究组 & 干预措施

Gait training for healthy

Active Comparator

干预措施: Split-belt treadmill training (Behavioral)

Gait training for stroke

Experimental

干预措施: Split-belt treadmill training (Behavioral)

结局指标

主要结局

Bilateral muscles activities during split-belt treadmill walking

时间窗: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle

Timing (milliseconds) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.

Trailing limb angle during split-belt treadmill walking

时间窗: Single point of assessment in one day and trailing limb angle will be recorded continuously for 20-30minutes and will be expressed per gait cycle

Peak trailing limb angle changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.

Spatiotemporal patterns during split-belt treadmill walking

时间窗: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.

Cadence (Step numbers/minute) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.

Bilateral symmetry of ground reaction forces during split-belt treadmill walking

时间窗: Single point of assessment in one day and ground reaction forces will be recorded continuously for 20-30minutes and will be expressed per gait cycle

Vertical, horizontal, and mediolateral ground reaction force changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.

Bilateral symmetry of joint torques during split-belt treadmill walking

时间窗: Single point of assessment in one day and joint torques will be recorded continuously for 20-30minutes and will be expressed per gait cycle

Joint torques changes of ankle, knee, and hip joints will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.

次要结局

  • Spatiotemporal patterns of overground walking(Baseline assessment before split/tied treadmill walking)
  • Kinematic representation of the temporal events during standing and walking(Baseline assessment before split/tied treadmill walking)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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