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临床试验/NCT00785343
NCT00785343Unknown1 期

Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
40
试验地点
2
主要终点
Fugl-Meyer Score

研究概览

简要总结

The purpose of this study is to compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements with help from the device.

详细描述

HYPOTHESES

  • Motor function will be significantly greater for the patients in the robotic training group as measured by standard clinical evaluations.
  • Functional independence gains will be similar for both groups because the robotic therapy is not task-specific for activities of daily living (ADL).
  • Robotic training will reduce pain and spasticity more effectively than conventional therapy alone, due to increased number of movements performed during the robotic training.
  • Muscle activation patterns for patients receiving robotic training will show decreased agonist/antagonist co-contraction and less erratic muscle activation.
  • Robotic training patients will demonstrate significantly greater ROM, movement accuracy and higher movement speed during exercises performed as part of robotic training. For robotic exercises performed only as part of the robotic assessment, these improvements will be significantly less than those for practiced movements.

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
65 Years 至 84 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right hemisphere, unilateral ischemic stroke with onset of less than 15 days that results in arm weakness Right-handed 65-84 years of age Manual Muscle Test score of at least 2/5 Must be able to follow 2-3 step commands Head, neck, and trunk control to maintain an upright posture for a minimum of 45 minutes Some synergistic movement at shoulder Active shoulder flexion and/or abduction greater then 30 degrees Active elbow flexion of 45 degrees or more

排除标准

  • Previous stroke history
  • Hemorrhagic stroke, cerebellar stroke, or subarachnoid hemorrhage
  • Contractures in the involved upper extremity at the shoulder, elbow, or wrist
  • Moderate to severe tone in the involved upper extremity
  • Flaccid involved upper extremity
  • Full, active isolated movement of the involved upper extremity
  • Corrected visual acuity worse than 20/50 for distance
  • Cognitive or other deficits that would negatively affect their ability to follow directions or track visual targets
  • Unstable cardiovascular orthopedic or neurological conditions that would preclude exercise in short-duration, high work-load trials

结局指标

主要结局

Fugl-Meyer Score

时间窗: Start and end of treatment

次要结局

  • EMG - muscle activation and co-contraction index(Start and end of treatment)

研究者

发起方
Kessler Foundation
申办方类型
Other

研究点 (2)

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