跳至主要内容
临床试验/NCT03466372
NCT03466372已完成不适用

Innovative Biofeedback Strategies for Gait Training

Emory University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月22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
20
试验地点
2
主要终点
paretic pushoff (AGRF)

研究概览

简要总结

The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression protocols for improved gait patterns and gait function. The study objectives are to (1) evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and (2) evaluate the feasibility and short-term effects on gait performance of a real-time biofeedback protocol incorporating progression criteria (similar to those employed during clinical rehabilitative training).

详细描述

Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Biomechanical impairments, such as reduced knee and ankle flexion during swing phase negatively affect gait function and increase the risk for falls. During the stance phase, decreased contribution of the paretic leg to forward propulsion during paretic terminal stance is a critical post-stroke gait deficit shown to be correlated with hemiparetic severity, walking speed, and gait asymmetry. These gait deficits can lead to falls, increased energy cost of gait, and decreased endurance. Also, a slowed self-selected walking speed is one of the hallmarks of post-stroke gait, and greatly limits community participation in individuals post-stroke. Very few interventions provide targeted practice of biomechanically appropriate movement patterns exclusively or preferentially to the paretic leg. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns. Real-time biofeedback gait training has been used for modulating step length asymmetry in people post-stroke. A recent study developed a protocol combining treadmill training with visual and auditory real-time biofeedback to increase anterior ground reaction force (AGRF). AGRF biofeedback may be a beneficial strategy to target unilateral propulsion deficits in people post-stroke. The goal of this study is to develop improved methodologies for AGRF gait biofeedback and to evaluate the feasibility and short-term effects of gait biofeedback. To achieve this goal, experiments will be performed on young able-bodied individuals as well as stroke survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke participants:
  • age 30-90 years (stroke) or 18-50 years (able-bodied controls)
  • chronic stroke (>6 months post stroke)
  • ambulatory with or without the use of a cane or walker
  • able to walk for 2 minutes at the self-selected speed without an orthoses
  • resting heart rate 40-100 beats per minute
  • Able-bodied participants:
  • age 18 to 50 years
  • no history of neurologic disease
  • no history of orthopedic disease or injury affecting the lower extremity.

排除标准

  • Stroke participants:
  • Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
  • History of lower extremity joint replacement
  • Inability to communicate with investigators
  • Neglect/hemianopia, or unexplained dizziness in last 6 months
  • Neurologic conditions other than stroke
  • Orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking.
  • Able-bodied controls
  • History of neurologic disease
  • History of orthopedic disease or injury to the lower extremity in the past 6 months
  • Pain or discomfort during walking
  • Cardiovascular or medical condition affecting ability to exercise or walk.

研究组 & 干预措施

biofeedback 1

Experimental

biofeedback training with progression of targets

干预措施: biofeedback (Behavioral)

biofeedback 2

Active Comparator

biofeedback training with progression of targets and speeds

干预措施: biofeedback (Behavioral)

结局指标

主要结局

paretic pushoff (AGRF)

时间窗: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)

peak GRF generated by the leg affected by the stroke

次要结局

  • non-paretic peak AGRF(Immediately after the 6-minute biofeedback training bout (Post-0 minutes))
  • paretic trailing limb angle(Immediately after the 6-minute biofeedback training bout (Post-0 minutes))

研究者

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

Trisha Kesar, PT, PhD

Assistant Professor

Emory University

研究点 (2)

Loading locations...

相似试验