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

Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Early Robotic/VR Therapy (EVR); Device: Delayed Robotic/VR Therapy (DVR); Behavioral: Dose-Matched Usual Physical Therapy Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Saddle Brook, New Jersey, United States, 07663
      • Kessler Institute for Rehabilitation
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: NJIT-RAVR, NJIT-TrackGlove
Experimental: 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.	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.; Other Names: NJIT-RAVR, NJIT-TrackGlove
No Intervention: Usual Physical Therapy Care; Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	The ARAT assesses upper extremity activity. It is a 19 item test divided into four	6 months post stroke
Action Research Arm Test	The ARAT assesses upper extremity activity. It is a 19 item test divided into four	1 month post treatment
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)
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)
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
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
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
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)
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)
EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	4 months post stroke
EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	6 months post stroke
EEG-Based Measure of Resting State Brain Connectivity	Electroencephalography will be used to evaluate resting-state brain connectivity.	1 month post treatment
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)
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)
EEG-Based Measure of Task-Based Brain Connectivity	Task-based connectivity will be evaluated.	4 months post stroke
EEG-Based Measure of Task-Based Brain Connectivity	Electroencephalography will be used to evaluate task-based brain connectivity.	6 months post stroke
EEG-Based Measure of Task-Based Brain Connectivity	Electroencephalography will be used to evaluate task-based brain connectivity.	1 month post treatment
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)
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)
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
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
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
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)
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)
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
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
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
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)
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)
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
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
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
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)
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)
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
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
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
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)
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)
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
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
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
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)
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)
Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	4 months post stroke
Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	6 months post stroke
Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	1 month post treatment
Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	Immediately post treatment (ideally within 72 hours)
Arm Range of Motion	Active range of motion for fingers, wrist, elbow and shoulder.	Immediately prior to treatment (ideally within 72 hours)
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
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
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
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)
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)
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
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
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
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)
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)
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
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
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
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)
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)
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
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
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
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
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
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
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)
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)
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
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
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
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)
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)
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
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
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
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
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

Collaborators and Investigators

• Sponsor: New Jersey Institute of Technology
• Collaborators: Kessler Foundation; Rutgers University; Northeastern University
• Investigators: Principal Investigator: Sergei V Adamovich, PhD, New Jersey Institute of Technology; Principal Investigator: Alma S Merians, PhD, PT, Rutgers University; Principal Investigator: Karen Nolan, PhD, Kessler Foundation; Principal Investigator: Eugene Tunik, PhD, PT, Northeastern University

Publications and helpful links

General Publications

• Merians AS, Fluet GG, Qiu Q, Yarossi M, Patel J, Mont AJ, Saleh S, Nolan KJ, Barrett AM, Tunik E, Adamovich SV. Hand Focused Upper Extremity Rehabilitation in the Subacute Phase Post-stroke Using Interactive Virtual Environments. Front Neurol. 2020 Nov 26;11:573642. doi: 10.3389/fneur.2020.573642. eCollection 2020.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Virtual Environment; Robotics; Hand; Transcranial Magnetic Stimulation; Upper Extremity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: R01HD058301 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No