Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
This study investigates the effects of intensive, high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations. There is a time-limited period of post-ischemic heightened neuronal plasticity during which intensive training may optimally affect the recovery of motor skills, indicating that the timing of rehabilitation is as important as the dosing. However, recent literature indicates a controversy regarding both the value of intensive, high dosage as well as the optimal timing for therapy in the first two months after stroke. This study is designed to empirically investigate this controversy. It is evident that providing additional, intensive therapy during the acute rehabilitation stay is more complicated to implement and difficult for patients to tolerate, than initiating it in the outpatient setting, immediately after discharge. The robotic/VR system is specifically designed to deliver hand and arm training when motion and strength are limited, using adaptive algorithms to drive individual finger movement, gain adaptation and workspace modification to increase finger and arm range of motion, and haptic and visual feedback from mirrored movements to reinforce motor networks in the lesioned hemisphere.
详细描述
This study investigates the effects of high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations on recovery and function of the hand, when the training is initiated within early period of heightened plasticity. The intervention uses two training systems. NJIT-RAVR consists of a data glove combined with the Haptic Master robot that provides tracking of movements in a 3D workspace and enables programmable haptic effects, such as variable anti-gravity support, springs and dampers, and various haptic objects. The NJIT-TrackGlove consists of a robotic hand exoskeleton to provide haptic effects or assistance and an instrumented glove for finger angle tracking, and an arm tracking system to track hand and arm position and orientation. Using programmable software and custom bracing we enable use of this system for patients with a broad set of impairments and functional abilities. A library of custom-designed impairment and task-based simulations that train arm transport and hand manipulation, together or separately will be used. Pilot data show that it is possible to integrate intensive, high-dosage, targeted hand therapy into the routine of an acute rehabilitation setting. The study integrates the behavioral, the kinematic/kinetic and neurophysiological aspects of recovery to determine: 1) whether early intensive training focusing on the hand will result in a more functional hemiparetic arm; (2) whether it is necessary to initiate intensive hand therapy during the very early inpatient rehabilitation phase or will comparable outcomes be achieved if the therapy is initiated right after discharge, in the outpatient period; and 3) whether the effect of the early intervention observed at 6 months post stroke can be predicted by the cortical reorganization evaluated immediately prior to the therapy. This study will fill critical gaps in the literature and make a significant advancement in the investigation of putative interventions for recovery of hand function in patients post-stroke.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral right or left sided stroke within 7 to 30 days of starting study
- •sufficient cognitive function to follow instructions
- •Fugl-Meyer (FM) of ≤ 49/66
- •intact cutaneous sensation (e.g. ability to detect <4.17 N stimulation using Semmes- Weinstein nylon filaments
排除标准
- •prior stroke with persistent motor impairment or other disabling neurologic condition
- •non-independent before stroke
- •receptive aphasia
- •hemispatial neglect or severe proprioceptive loss
- •significant illnesses
- •severe arthritis that limits arm and hand movements
- •a score of ≥1 on the NIHSS limb ataxia item
研究组 & 干预措施
Usual Physical Therapy Care
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Early Robotic/VR Therapy (EVR)
Subjects in this group will receive state-of-art inpatient usual care therapy plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated 5-30 days post stroke.
干预措施: Early Robotic/VR Therapy (EVR) (Device)
Delayed Robotic/VR Therapy (DVR)
Subjects in this group will receive state-of-art usual care therapy (inpatient and outpatient) plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated within 31-60 days post stroke.
干预措施: Delayed Robotic/VR Therapy (DVR) (Device)
Dose-Matched Usual Physical Therapy Care
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care plus an extra hour of state-of-art usual care.
干预措施: Dose-Matched Usual Physical Therapy Care (Behavioral)
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: 4 months post stroke
The ARAT assesses upper extremity activity. It is a 19 item test divided into four subscales: grasp, grip, pinch and movement. Scores range from 0-57 with higher scores indicating better performance.
次要结局
- Coordination between Hand Transport and Grasp during Reaching(Immediately prior to treatment (ideally within 72 hours))
- EuroQol(Immediately prior to treatment (ideally within 72 hours))
- Change in Robot-Based Measure of Elbow-Shoulder Coordination during Reaching(Day 1 and and Day 10 of treatment for EVR and DVR groups)
- EEG-Based Measure of Task-Based Brain Connectivity(Immediately prior to treatment (ideally within 72 hours))
- Wolf Motor Function Test(Immediately prior to treatment (ideally within 72 hours))
- Cerebral Oxygenation in Sensorimotor Cortex(Immediately prior to treatment (ideally within 72 hours))
- Arm Range of Motion(Immediately prior to treatment (ideally within 72 hours))
- Maximum Thumb and Index Fingertip Pinch Force(Immediately prior to treatment (ideally within 72 hours))
- Action Research Arm Test(Immediately prior to treatment (ideally within 72 hours))
- Cortical Area Representation of the Finger-Hand Muscles(Immediately prior to treatment (ideally within 72 hours))
- Blocks and Box Test(Immediately prior to treatment (ideally within 72 hours))
- Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force(Immediately prior to treatment (ideally within 72 hours))
- EEG-Based Measure of Resting State Brain Connectivity(Immediately prior to treatment (ideally within 72 hours))
- Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)(Immediately prior to treatment (ideally within 72 hours))
- Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension(Immediately prior to treatment (ideally within 72 hours))
- Measurement of Daily Use of Upper Extremity(1 month post treatment)
- National Institutes of Health Stroke Scale (NIHSS)(Immediately prior to treatment (ideally within 72 hours))
- Patient's Structured Subjective Assessment(Immediately post treatment (ideally within 72 hours) for EVR and DVR groups)
- Change in Robot-Based Measure of Maximum Seated Workspace during Reaching(Day 1 and and Day 10 of treatment for EVR and DVR groups)
- Change in Robot-Based Measure of Movement Speed during Arm Reaching(Day 1 and and Day 10 of treatment for EVR and DVR groups)
- Change in Robot-Based Measure of Movement Speed during Targeted Finger Motion(Day 1 and and Day 10 of treatment for EVR and DVR groups)
- Action Research Arm Test(6 months post stroke)
- Action Research Arm Test(1 month post treatment)
- Action Research Arm Test(Immediately post treatment (ideally within 72 hours))
- Cortical Area Representation of the Finger-Hand Muscles(4 months post stroke)
- Cortical Area Representation of the Finger-Hand Muscles(6 months post stroke)
- Cortical Area Representation of the Finger-Hand Muscles(1 month post treatment)
- Cortical Area Representation of the Finger-Hand Muscles(Immediately post treatment (ideally within 72 hours))
- EEG-Based Measure of Resting State Brain Connectivity(4 months post stroke)
- EEG-Based Measure of Resting State Brain Connectivity(6 months post stroke)
- EEG-Based Measure of Resting State Brain Connectivity(1 month post treatment)
- EEG-Based Measure of Resting State Brain Connectivity(Immediately post treatment (ideally within 72 hours))
- EEG-Based Measure of Task-Based Brain Connectivity(4 months post stroke)
- EEG-Based Measure of Task-Based Brain Connectivity(6 months post stroke)
- EEG-Based Measure of Task-Based Brain Connectivity(1 month post treatment)
- EEG-Based Measure of Task-Based Brain Connectivity(Immediately post treatment (ideally within 72 hours))
- Cerebral Oxygenation in Sensorimotor Cortex(4 months post stroke)
- Cerebral Oxygenation in Sensorimotor Cortex(6 months post stroke)
- Cerebral Oxygenation in Sensorimotor Cortex(1 month post treatment)
- Cerebral Oxygenation in Sensorimotor Cortex(Immediately post treatment (ideally within 72 hours))
- Blocks and Box Test(4 months post stroke)
- Blocks and Box Test(6 months post stroke)
- Blocks and Box Test(1 month post treatment)
- Blocks and Box Test(Immediately post treatment (ideally within 72 hours))
- Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)(4 months post stroke)
- Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)(6 months post stroke)
- Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)(1 month post treatment)
- Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)(Immediately post treatment (ideally within 72 hours))
- Wolf Motor Function Test(4 months post stroke)
- Wolf Motor Function Test(6 months post stroke)
- Wolf Motor Function Test(1 month post treatment)
- Wolf Motor Function Test(Immediately post treatment (ideally within 72 hours))
- Coordination between Hand Transport and Grasp during Reaching(4 months post stroke)
- Coordination between Hand Transport and Grasp during Reaching(6 months post stroke)
- Coordination between Hand Transport and Grasp during Reaching(1 month post treatment)
- Coordination between Hand Transport and Grasp during Reaching(Immediately post treatment (ideally within 72 hours))
- Arm Range of Motion(4 months post stroke)
- Arm Range of Motion(6 months post stroke)
- Arm Range of Motion(1 month post treatment)
- Arm Range of Motion(Immediately post treatment (ideally within 72 hours))
- Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force(4 months post stroke)
- Maximum Thumb and Index Fingertip Pinch Force(1 month post treatment)
- Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force(6 months post stroke)
- Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force(1 month post treatment)
- Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force(Immediately post treatment (ideally within 72 hours))
- Maximum Thumb and Index Fingertip Pinch Force(4 months post stroke)
- Maximum Thumb and Index Fingertip Pinch Force(6 months post stroke)
- Maximum Thumb and Index Fingertip Pinch Force(Immediately post treatment (ideally within 72 hours))
- Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension(4 months post stroke)
- Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension(6 months post stroke)
- Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension(1 month post treatment)
- Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension(Immediately post treatment (ideally within 72 hours))
- Measurement of Daily Use of Upper Extremity(4 months post stroke)
- Measurement of Daily Use of Upper Extremity(6 months post stroke)
- EuroQol(4 months post stroke)
- EuroQol(6 months post stroke)
- National Institutes of Health Stroke Scale (NIHSS)(1 month post treatment)
- EuroQol(1 month post treatment)
- EuroQol(Immediately post treatment (ideally within 72 hours))
- National Institutes of Health Stroke Scale (NIHSS)(4 months post stroke)
- National Institutes of Health Stroke Scale (NIHSS)(6 months post stroke)
- National Institutes of Health Stroke Scale (NIHSS)(Immediately post treatment (ideally within 72 hours))
研究者
Sergei V. Adamovich PhD
Professor
New Jersey Institute of Technology