跳至主要内容
临床试验/NCT00864708
NCT00864708终止不适用

Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2008年12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
终止
入组人数
1
试验地点
1
主要终点
Walking Endurance (6MWT)

研究概览

简要总结

The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.

详细描述

Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment.

Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Sufficient endurance to participate in rehabilitation sessions.
  • •Medically Stable
  • •Age >21 years.
  • •Inability to perform normal ankle coordinated gait components.
  • •Participants should be able to walk and keep balance without physical assistance from another person

排除标准

  • •Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
  • •Lower motor neuron damage or radiculopathy
  • •Allergy or contraindication to anesthesia, Versed, (or comparable substitute.
  • •Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device.
  • •Pregnancy

研究组 & 干预措施

Arm 1

Experimental

radio frequency-controlled (RF) Microstimulator (RFM) Gait System

干预措施: radio frequency-controlled (RF) Microstimulator (RFM) Gait System (Device)

结局指标

主要结局

Walking Endurance (6MWT)

时间窗: Day 1 and at 3 months, following treatment

The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.

Kinematic Gait Measures

时间窗: Day 1 and at 3 months, following treatment

assessment of the lower limb kinematics during ambulation at chosen speed.

次要结局

  • Fugl-Meyer Lower Extremity Score(Day 1 and at 3 months, following treatment)
  • Ashworth Scale(Day 1 and at 3 months, following treatment)
  • Stroke Impact Scale (SIS)(Day 1 and at 3 months, following treatment)
  • Manual Muscle Testing (MMT)(Day 1 and at 3 months, following treatment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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