跳至主要内容
临床试验/NCT00435617
NCT00435617已完成不适用

Clinical Assessment of a Massed Practice Therapy Device

Kinetic Muscles4 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2005年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
4
主要终点
Wolf Motor Function Test

研究概览

简要总结

The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.

详细描述

Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 3 to 24 months post stroke
  • Able to extend wrist and fingers at least 10 degrees
  • Functional hearing and vision
  • Able to follow instructions
  • Lives at home, not institution
  • Stable medications for 3 months

排除标准

  • Excessive cognitive impairments
  • Taking/Receiving medicines/shots to make arm/hand less stiff
  • Severe pain in the impaired arm
  • Stroke was more than 24 months ago

结局指标

主要结局

Wolf Motor Function Test

时间窗: Initial, 6 wks, 12 wks, 16 wks, 52 wks

次要结局

  • Compliance with recommended use(6 wks, 12 wks)
  • Fugl-Meyer Test(Initial, 6 wks, 12 wks, 16 wks, 52 wks)
  • Stoke Impact Scale(Initial, 6 wks, 12 wks, 16 wks, 52 wks)

研究者

发起方
Kinetic Muscles
申办方类型
Industry
责任方
Principal Investigator
主要研究者

James Koeneman

Chief Science Officer

Kinetic Muscles

研究点 (4)

Loading locations...

相似试验

Study of Hand Therapy 3 to 24 Months After Stroke | 临床试验