EXTREMITY CONSTRAINT INDUCED THERAPY EVALUATION (EXCITE)

肢体约束诱导治疗评估（EXCITE）

基本信息

批准号：
6721487
负责人：
STEVEN L. WOLF
金额：
$ 68.82万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
起止时间：
2000-04-01 至 2008-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6721487
关键词：
acute disease /disorder arm chronic disease /disorder clinical research clinical trials fingers functional ability human subject human therapy evaluation immobilization of body part limb movement longitudinal human study outcomes research psychomotor function rehabilitation restraint stroke therapy wrist

项目摘要

Profoundly impaired motor dysfunction is a major consequence of stroke. As a result, a large number of the more than 700,000 people in America sustaining a stroke each year have limitations in motor ability and compromised quality of life. Therapeutic interventions designed to enhance motor function and promote independent use of an impaired upper extremity following stroke are quite limited. There is a need to translate unique behavioral techniques shown to have impact on plasticity in the nervous system into practical, evidence-based, therapeutic interventions, especially at a time when the duration and number of treatments have been retracted. One such technique, derived from basic research with animals and human subjects has produced results that can substantially reduce the incapacitating deficits of many patients with chronic stroke and can increase their independence. The techniques, termed Constraint-Induced (CI) Movement Therapy or Forced Use, involve motor restriction of the less affected upper extremity for two weeks. Over this time, repetitive use of the more affected upper extremity is promoted for many hours a day. This treatment produces long-lasting improvements in real world extremity use among patients who are more than 1 year post-stroke and who have an ability to initiate some extension in wrist and digit joints. This intervention has never been studied across facilities systematically, nor has it been applied to sub-acute patients. Pilot work from 6 sites indicates that CI therapy may be as effective for sub-acute patients, 3-6 months post-stroke, as it is for more chronic patients. This prospective, 5-year, randomized national clinical trial, including 2-year follow-up will use a crossover design. Sub-acute patients with stroke with at least minimal ability to extend at wrist and digits (N=240) will be randomly assigned to receive CI therapy or the customary care normally available to them; 40 patients will be tested at each of 6 sites. One year after intake, control patients will be crossed over to receive CI therapy. All patients will be stratified into equal numbers of higher and lower functioning patients, categorized by movement criteria. Primary outcome measures are a laboratory motor function test and amount of extremity use in the real world setting. Changes in psychosocial functioning will also be measured.

严重受损的运动功能障碍是中风的主要后果。因此，美国每年有超过 700,000 名中风患者，其中很大一部分人的运动能力受到限制，生活质量也受到影响。旨在增强运动功能和促进中风后受损上肢独立使用的治疗干预措施非常有限。有必要将已证明对神经系统可塑性有影响的独特行为技术转化为实用的、基于证据的治疗干预措施，特别是在治疗的持续时间和次数已被取消的情况下。其中一项技术源自对动物和人类受试者的基础研究，其结果可以大大减少许多慢性中风患者的失能缺陷，并提高他们的独立性。这些技术被称为约束诱导（CI）运动疗法或强迫使用，涉及对受影响较小的上肢进行为期两周的运动限制。在此期间，每天数小时内重复使用受影响较严重的上肢。对于中风后 1 年以上且能够开始手腕和手指关节伸展的患者来说，这种治疗可以在现实世界的肢体使用方面产生持久的改善。这种干预措施从未在各个机构进行过系统研究，也没有应用于亚急性患者。 6 个地点的试点工作表明，CI 疗法对于中风后 3-6 个月的亚急性患者可能与慢性患者一样有效。这项为期 5 年的前瞻性全国随机临床试验（包括 2 年随访）将采用交叉设计。手腕和手指伸展能力至少最低的亚急性中风患者 (N=240) 将被随机分配接受 CI 治疗或通常可用的常规护理； 6 个地点各有 40 名患者接受检测。摄入一年后，对照患者将交叉接受 CI 治疗。所有患者将根据运动标准分为同等数量的功能较高和功能较低的患者。主要结果指标是实验室运动功能测试和现实世界中肢体的使用量。心理社会功能的变化也将被测量。

项目成果

期刊论文数量（37）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

What is constraint-induced therapy?

什么是约束诱导疗法？

DOI：
10.1002/j.2048-7940.2004.tb00326.x
发表时间：
2004
期刊：
Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses
影响因子：
0
作者：
Aycock,DawnM;Blanton,Sarah;Clark,PatriciaC;Wolf,StevenL
通讯作者：
Wolf,StevenL

The EXCITE Trial: Predicting a clinically meaningful motor activity log outcome.

DOI：
10.1177/1545968308316906
发表时间：
2008-09
期刊：
Neurorehabilitation and neural repair
影响因子：
4.2
作者：
Park SW;Wolf SL;Blanton S;Winstein C;Nichols-Larsen DS
通讯作者：
Nichols-Larsen DS

Caregiver characteristics predict stroke survivor quality of life at 4 months and 1 year.

DOI：
10.1002/nur.20348
发表时间：
2009-12
期刊：
RESEARCH IN NURSING & HEALTH
影响因子：
2
作者：
Klinedinst, N. Jennifer;Gebhardt, Mary C.;Aycock, Dawn M.;Nichols-Larsen, Deborah S.;Uswatte, Gitendra;Wolf, Steven L.;Clark, Patricia C.
通讯作者：
Clark, Patricia C.

Minimal detectable change of the actual amount of use test and the motor activity log: the EXCITE Trial.