Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1
研究概览
简要总结
This study will test the hypothesis that the combination of low-moderate to severe motor deficits in the paretic arm and persistent motor deficits in the less-impaired arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.
详细描述
We previously characterized hemisphere-specific motor control deficits in the non-paretic arm of unilaterally lesioned stroke survivors. Our preliminary data indicate these deficits are substantial and functionally limiting in patients with severe paresis. We have specifically designed an intervention to remediate the hemisphere-specific deficits in the less-impaired arm, using a virtual-reality platform, and then follow this training with manipulation training of a variety of real objects, designed to facilitate generalization and transfer to functional behaviors encountered in the natural environment. We propose a 2-site, two-group randomized intervention with a treatment group, which will receive unilateral training of the less-impaired arm, through our Virtual Reality and Manipulation Training (VRMT) protocol. This intervention protocol is grounded in the premise that targeted remediation of fundamental control deficits exhibited by the less-impaired arm will generalize and transfer beyond practiced tasks to performance of activities of daily living (ADL). This approach contrasts with the more pragmatic approach of task-specific training of essential ADL's, which is limited in scope, more cumbersome, and ignores known fundamental motor control deficits. Our control group will receive conventional intervention, guided by recently released practice guidelines for upper limb intervention in adult stroke. The impact of the proposed research is that we address persistent functional performance deficits in chronic stroke patients with severe paresis, who's less-impaired arm impairments are generally ignored in most current rehabilitation protocols. Our first aim addresses the overall effectiveness of this intervention, relative to our control group: To determine whether non-paretic arm VRMT in chronic stroke survivors with severe paresis will produce durable improvements in less-impaired arm motor performance that will generalize to improve functional activities and functional independence to a greater extent than conventional therapy focused on the paretic arm. Our second aim focuses on the mechanistic basis of potential training-related improvements in motor performance: To determine whether intervention-induced improvements in less-impaired arm performance are associated with improvements in hemisphere-specific reaching kinematics. Finally, our third aim monitors for potential negative effects of our experimental intervention on paretic arm impairment.
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)
盲法说明
The outcome assessor will assess all participants and be unaware of the participants' group assignment.
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
- 否
入选标准
- •neuroradiological confirmation of unilateral brain damage with residual contralesional upper-extremity weakness
- •deficits in ipsilesional arm performance assessed by the JTHFT
- •6+ months post stroke
- •Demonstrates cognitive abilities
排除标准
- •a history of:
- •neurological disease other than stroke (e.g., head trauma)
- •a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder),
- •hospital admission for substance abuse
- •peripheral disorders affecting sensation or movement of the upper extremities, including pain or arthritis
- •currently taking prescription drugs with known sedative properties that are interfering with sensory-motor function
- •significant joint pain that is activity limiting
- •bilateral stroke
结局指标
主要结局
Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1
时间窗: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Measure of functional independence in self care activities scored from 0-100 with higher scores indicating more functional independence. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.
Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1
时间窗: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living. The test includes 7 timed (seconds) activities (possible 0-120 seconds each); the analysis excludes the writing component, therefore it includes 6 of the 7 original JTHFT components. Faster performance yields lower scores (time). There were 2 baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.
Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1
时间窗: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Participant reported outcome of difficulty of upper extremity based activities. Scores are transformed to logit scores. The items ranged on the interval scale from -2.18 to 1.72 log-odds units, called 'logits', with higher logit values indicating more difficult activities. Deltas of logits from baseline 2 to post test 1 are reported. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores. Results do not include covariates.
Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1
时间窗: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Upper-Extremity Measure of paretic arm impairment out of 66 possible points with higher scores indicating more movement, and 0 indicating no functional movement in the arm. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.
次要结局
- Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components(Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session))
- Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics)(Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session))
- Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1(Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session))
研究者
Robert L. Sainburg
Professor of Kinesiology and Neurology
Milton S. Hershey Medical Center