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The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke

2015年10月5日 更新者:Michael Ellis、Northwestern University
Disturbances in movement coordination are the least well understood but often the most debilitating with respect to functional recovery following stroke. These deficits in coordination are expressed in the form of abnormal muscle synergies and result in limited and stereotypic movement patterns that are functionally disabling. The result of these constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an individual with stroke when they lift up the weight of the impaired arm against gravity. The investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated research grant, has shown that the abnormal synergy between shoulder abduction and elbow flexion can be significantly reduced thus increasing total reaching range of motion in individuals with severe stroke. The previous work established progressive abduction loading as a key element to the rehabilitation of reaching. Although individuals with severe stroke benefited from the investigators previous work, residual flexion synergy continued to hinder normal arm function in most participants with severe stroke. This study will utilize the ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate resistance to reaching while accounting for the known benefits of progressive abduction loading. The investigators propose to randomize forty participants with severe stroke into two closely related interventions. The groups will both practice reaching under abduction loading, however, the experimental group will also move against resistance while reaching. Rigorous and quantitative investigation of therapeutic elements such as resistance to reaching and progressive abduction loading is only possible with a device such as the ACT3D. the investigators will be able to standardize the delivery of each intervention using kinematic and kinetic parameters, which will allow for a clear identification of the therapeutic effect of resistance to reaching. the investigators hypothesize that resistance to reaching in combination with progressive abduction loading will further increase dynamic multi-joint strength, increase total reaching range of motion, and increase arm function thus enhancing actual amount of use of the arm, participation in life roles, and quality of life in individuals with severe stroke.

研究概览

研究类型

介入性

注册 (实际的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60611
        • Department of Physical Therapy and Human Movement Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Paresis confined to one side, with substantial motor impairment of the upper limb
  • Absence of motor impairment in the unimpaired limb
  • Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment, changes in management of hypertension)
  • Absence of any acute or chronic painful condition in the upper extremities or spine
  • Absence of hemineglect
  • Capacity to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Viscous Resistance & Abduction Loading
The intervention for the experimental group entails practicing reaching utilizing the robotic device, ACT3D, with the experimental element of horizontal viscosity in combination with abduction loading.
All participants will undergo 8 weeks of reaching practice in the ACT3D. Frequency and duration will be matched at three 1.5-hour sessions per week. All reaching practice will include abduction (gravity) loading standardized to the participant's motor abilities. The experimental group intervention will also include a horizontal viscous resistant element similar to pushing the arm through molasses.
有源比较器:Abduction Loading
The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
All participants will undergo 8 weeks of reaching practice in the ACT3D. Frequency and duration will be matched at three 1.5-hour sessions per week. All reaching practice will include abduction (gravity) loading standardized to the participant's motor abilities. The experimental group intervention will also include a horizontal viscous resistant element similar to pushing the arm through molasses.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Peak Endpoint Reaching Velocity
大体时间:Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
We will quantify peak endpoint reaching velocity with a robotic device, ACT3D, when a participant with stroke reaches as fast as they can toward an outward target under various abduction (gravity) loading conditions. This measure will serve as the primary measure for changes in dynamic multi-joint strength.
Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
Change in Reaching Work Area
大体时间:Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
We will quantify total reaching work area (combined shoulder and elbow range of motion) with a robotic device, ACT3D, under various abduction (gravity) loading conditions. This measure will serve as the primary measure changes in dynamic multi-joint range of motion.
Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)

次要结果测量

结果测量
措施说明
大体时间
Fugl-Meyer Motor Assessment
大体时间:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Qualitative and clinical assessment of general motor impairment of arm following stroke.
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Rancho Los Amigos Functional Test for the Hemiparetic Upper Extremity
大体时间:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Qualitative and clinical assessment of activity limitation (function) of the arm following stroke.
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Stroke Impact Scale
大体时间:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Structured interview to assess all domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke.
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Motor Activity Log
大体时间:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Structured interview assessing the individual with stroke's perception of difficulty in the context of arm function during a variety of activities of daily living.
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2015年7月1日

研究完成 (实际的)

2015年7月1日

研究注册日期

首次提交

2012年2月29日

首先提交符合 QC 标准的

2012年3月5日

首次发布 (估计)

2012年3月8日

研究记录更新

最后更新发布 (估计)

2015年10月6日

上次提交的符合 QC 标准的更新

2015年10月5日

最后验证

2015年10月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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