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临床试验/NCT01088230
NCT01088230已完成1 期

The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke: A Double Blind, Placebo-Controlled Pilot Study

New York Presbyterian Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Change scores on Fugl Meyer- Upper Extremity Section

研究概览

简要总结

The purpose of this study is to see whether treating subjects for wrist rehabilitation following stroke with Botox® and robotic therapy is more effective than treatment with robotic therapy alone and no Botox®.

详细描述

This study will explore new ways to facilitate rehabilitation of wrist function after stroke. One of the challenges of recovery is muscle stiffness or excessive muscle tone that often limits exercise or therapy progress. Taking this into account, the investigators propose treating the wrist and forearm with a combination of a one-time Botox® injection and a 6-week robotic therapy protocol to maximize recovery.

Botox® is a drug that is injected directly into a muscle to temporarily relax the muscle. Botox® is commonly used to decrease muscle tone in tight muscles in the stroke population. Robotics therapy provides highly repetitive mass practice with visual and haptic feedback.

Subjects will be randomized to two groups. Group A will receive the Botox® injection and group B will receive a placebo saline injection. Both groups will receive the same robotics therapy protocol. Subjects and investigators will be blinded to group assignment. The investigators would like to know if there are trends between groups in a variety of outcome measures depending on what intervention they received. The investigators predict that the treatment group will have better results than the control group on the Fugl Meyer, our primary outcome measure. The investigators hope the results of this pilot study will guide development of a larger clinical trial.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • > 6 months post-stroke
  • Single stroke
  • Ashworth Scale of > 2 but < 4 for wrist flexors and pronators
  • Able to follow multiple step directions
  • Completed all active occupational therapy
  • Motor strength > 1/5 at the wrist extension and supination
  • Passive ROM of 0-45 degrees at wrist flexion and extension, 0-20 degrees at radial deviation, 0-20 degrees at ulnar deviation, 0-45 degrees at pronation and supination
  • No Botox® injection in the wrist/forearm muscles for at least 12 months
  • Naïve to robotics study protocol

排除标准

  • Joint contracture and wrist or forearm

结局指标

主要结局

Change scores on Fugl Meyer- Upper Extremity Section

时间窗: at baseline and discharge

The Fugl Meyer assess quality of movement of the limb at an impairment level.

次要结局

  • Change on kinematic analysis(before injection and one week post injection)

研究者

申办方类型
Other

研究点 (1)

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