Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)

Stroke, Acute Clinical Trial

— RAVR  

Official title:

Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03569059
• Other study ID #: R01HD058301
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: New Jersey Institute of Technology
• Contact: Sergei V Adamovich, PhD
• Phone: 973-596-3413
• Email: sergei.adamovich[@]njit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Early Robotic/VR Therapy (EVR)
Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 5-30 days post stroke.

Behavioral:
• Dose-Matched Usual Physical Therapy Care
Subjects will perform state-of-art usual physical/occupational care and 10 days of one additional hour of state-of-art usual inpatient and/or outpatient physical therapy/occupational therapy.

Device:
• Delayed Robotic/VR Therapy (DVR)
Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 31-60 days post stroke.

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	Saddle Brook	New Jersey
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
New Jersey Institute of Technology	Kessler Foundation, Northeastern University, Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test (ARAT)	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.	4 months post stroke
Secondary	Action Research Arm Test	The ARAT assesses upper extremity activity. It is a 19 item test divided into four	6 months post stroke
Secondary	Action Research Arm Test	The ARAT assesses upper extremity activity. It is a 19 item test divided into four	1 month post treatment
Secondary	Action Research Arm Test	The ARAT assesses upper extremity activity. It is a 19 item test divided into four	Immediately post treatment (ideally within 72 hours)
Secondary	Action Research Arm Test	The ARAT assesses upper extremity activity. It is a 19 item test divided into four	Immediately prior to treatment (ideally within 72 hours)
Secondary	Cortical Area Representation of the Finger-Hand Muscles	Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.	4 months post stroke
Secondary	Cortical Area Representation of the Finger-Hand Muscles	Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.	6 months post stroke
Secondary	Cortical Area Representation of the Finger-Hand Muscles	Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.	1 month post treatment
Secondary	Cortical Area Representation of the Finger-Hand Muscles	Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.	Immediately post treatment (ideally within 72 hours)
Secondary	Cortical Area Representation of the Finger-Hand Muscles	Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.	Immediately prior to treatment (ideally within 72 hours)
Secondary	EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	4 months post stroke
Secondary	EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	6 months post stroke
Secondary	EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	1 month post treatment
Secondary	EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	Immediately post treatment (ideally within 72 hours)
Secondary	EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	Immediately prior to treatment (ideally within 72 hours)
Secondary	EEG-Based Measure of Task-Based Brain Connectivity	Task-based connectivity will be evaluated.	4 months post stroke
Secondary	EEG-Based Measure of Task-Based Brain Connectivity	Electroencephalography will be used to evaluate task-based brain connectivity.	6 months post stroke
Secondary	EEG-Based Measure of Task-Based Brain Connectivity	Electroencephalography will be used to evaluate task-based brain connectivity.	1 month post treatment
Secondary	EEG-Based Measure of Task-Based Brain Connectivity	Electroencephalography will be used to evaluate task-based brain connectivity.	Immediately post treatment (ideally within 72 hours)
Secondary	EEG-Based Measure of Task-Based Brain Connectivity	Electroencephalography will be used to evaluate task-based brain connectivity.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Cerebral Oxygenation in Sensorimotor Cortex	Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.	4 months post stroke
Secondary	Cerebral Oxygenation in Sensorimotor Cortex	Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.	6 months post stroke
Secondary	Cerebral Oxygenation in Sensorimotor Cortex	Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.	1 month post treatment
Secondary	Cerebral Oxygenation in Sensorimotor Cortex	Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.	Immediately post treatment (ideally within 72 hours)
Secondary	Cerebral Oxygenation in Sensorimotor Cortex	Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Blocks and Box Test	A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.	4 months post stroke
Secondary	Blocks and Box Test	A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.	6 months post stroke
Secondary	Blocks and Box Test	A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.	1 month post treatment
Secondary	Blocks and Box Test	A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.	Immediately post treatment (ideally within 72 hours)
Secondary	Blocks and Box Test	A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)	An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.	4 months post stroke
Secondary	Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)	An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.	6 months post stroke
Secondary	Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)	An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.	1 month post treatment
Secondary	Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)	An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.	Immediately post treatment (ideally within 72 hours)
Secondary	Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)	An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Wolf Motor Function Test	A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.	4 months post stroke
Secondary	Wolf Motor Function Test	A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.	6 months post stroke
Secondary	Wolf Motor Function Test	A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.	1 month post treatment
Secondary	Wolf Motor Function Test	A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.	Immediately post treatment (ideally within 72 hours)
Secondary	Wolf Motor Function Test	A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Coordination between Hand Transport and Grasp during Reaching	The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.	4 months post stroke
Secondary	Coordination between Hand Transport and Grasp during Reaching	The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.	6 months post stroke
Secondary	Coordination between Hand Transport and Grasp during Reaching	The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.	1 month post treatment
Secondary	Coordination between Hand Transport and Grasp during Reaching	The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.	Immediately post treatment (ideally within 72 hours)
Secondary	Coordination between Hand Transport and Grasp during Reaching	The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	4 months post stroke
Secondary	Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	6 months post stroke
Secondary	Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	1 month post treatment
Secondary	Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	Immediately post treatment (ideally within 72 hours)
Secondary	Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force	Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.	4 months post stroke
Secondary	Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force	Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.	6 months post stroke
Secondary	Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force	Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.	1 month post treatment
Secondary	Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force	Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.	Immediately post treatment (ideally within 72 hours)
Secondary	Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force	Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Maximum Thumb and Index Fingertip Pinch Force	A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.	4 months post stroke
Secondary	Maximum Thumb and Index Fingertip Pinch Force	A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.	6 months post stroke
Secondary	Maximum Thumb and Index Fingertip Pinch Force	A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.	1 month post treatment
Secondary	Maximum Thumb and Index Fingertip Pinch Force	A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.	Immediately post treatment (ideally within 72 hours)
Secondary	Maximum Thumb and Index Fingertip Pinch Force	A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension	A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.	4 months post stroke
Secondary	Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension	A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.	6 months post stroke
Secondary	Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension	A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.	1 month post treatment
Secondary	Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension	A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.	Immediately post treatment (ideally within 72 hours)
Secondary	Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension	A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Measurement of Daily Use of Upper Extremity	Wearable sensors will be used to quantify daily use of the affected arm after the intervention.	4 months post stroke
Secondary	Measurement of Daily Use of Upper Extremity	Wearable sensors will be used to quantify daily use of the affected arm after the intervention.	6 months post stroke
Secondary	Measurement of Daily Use of Upper Extremity	Wearable sensors will be used to quantify daily use of the affected arm after the intervention.	1 month post treatment
Secondary	EuroQol	The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.	4 months post stroke
Secondary	EuroQol	The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.	6 months post stroke
Secondary	EuroQol	The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.	1 month post treatment
Secondary	EuroQol	The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.	Immediately post treatment (ideally within 72 hours)
Secondary	EuroQol	The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.	Immediately prior to treatment (ideally within 72 hours)
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.	4 months post stroke
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.	6 months post stroke
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.	1 month post treatment
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.	Immediately post treatment (ideally within 72 hours)
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.	Immediately prior to treatment (ideally within 72 hours)
Secondary	Change in Robot-Based Measure of Elbow-Shoulder Coordination during Reaching	To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in patterns of elbow-shoulder coordination.	Day 1 and and Day 10 of treatment for EVR and DVR groups
Secondary	Change in Robot-Based Measure of Maximum Seated Workspace during Reaching	To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in maximum seated workspace.	Day 1 and and Day 10 of treatment for EVR and DVR groups
Secondary	Change in Robot-Based Measure of Movement Speed during Arm Reaching	To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed immediately prior to VR training to measure changes in arm speed during reaching for a virtual target.	Day 1 and and Day 10 of treatment for EVR and DVR groups
Secondary	Change in Robot-Based Measure of Movement Speed during Targeted Finger Motion	To compare the immediate effects of training in the EVR and DVR groups, subjects will perform targeted finger movements in a virtual environment. The test will be performed every day immediately prior to VR training to measure changes in the speed of finger movement towards a virtual target.	Day 1 and and Day 10 of treatment for EVR and DVR groups
Secondary	Patient's Structured Subjective Assessment	This is a 27 item questionnaire that addresses the subjects perception of the function of their hemiplegic arm and the effect this intervention had on their hand function. Subjects fill out the questionnaire prior to and directly after the intervention. Some questions require a response such as disagree, neutral and agree, others require ordering their gaming activity preferences, or responding to a question with a short answer.	Immediately post treatment (ideally within 72 hours) for EVR and DVR groups

External Links

•   The web site describes the Center for Rehabilitation Robotics at NJIT where the technologies used in this study are being developed.