Stroke, AcuteRAVRNCT03569059

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

A study testing Early Robotic/VR Therapy (EVR), Dose-Matched Usual Physical Therapy Care and Delayed Robotic/VR Therapy (DVR) in people with Stroke, Acute, run by New Jersey Institute of Technology at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Stroke, Acute
What is being tested?: Early Robotic/VR Therapy (EVR), Dose-Matched Usual Physical Therapy Care and Delayed Robotic/VR Therapy (DVR)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 2 sitesUnited States
Study dates: 24 Aug 2018to 15 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Stroke, Acute
Being tested: Early Robotic/VR Therapy (EVR), Dose-Matched Usual Physical Therapy Care, Delayed Robotic/VR Therapy (DVR)
Keywords: Stroke, Virtual Environment, Robotics, Upper Extremity, Hand, Transcranial Magnetic Stimulation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early Robotic/VR Therapy (EVR)Device
Also called NJIT-RAVR, NJIT-TrackGlove
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.
Dose-Matched Usual Physical Therapy CareBehavioural
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.
Delayed Robotic/VR Therapy (DVR)Device
Also called NJIT-RAVR, NJIT-TrackGlove
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.

Study groups in NCT03569059
Study group	Role	What they receive
Early Robotic/VR Therapy (EVR)	Experimental	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. Receives: Device: Early Robotic/VR Therapy (EVR)
Delayed Robotic/VR Therapy (DVR)	Experimental	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. Receives: Device: Delayed Robotic/VR Therapy (DVR)
Usual Physical Therapy Care	No intervention	Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Dose-Matched Usual Physical Therapy Care	Experimental	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. Receives: Behavioral: Dose-Matched Usual Physical Therapy Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 months post stroke

Secondary outcomes (82)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201815 Aug 2024

First posted26 Jun 2018
Study start24 Aug 2018
Primary completion15 Aug 2024
Study completion15 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are assigned to one of four groups in parallel for the duration of the study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03569059
Sponsor's protocol ID: R01HD058301
Acronym: RAVR
Status last verified: Oct 2024
First submitted: 10 Apr 2018
Last updated: 3 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 33324323

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments
ClinicalTrials.gov ID: NCT03569059
Acronym / sponsor ID: RAVR / R01HD058301
Conditions: Stroke, Acute
Keywords: Stroke, Virtual Environment, Robotics, Upper Extremity, Hand, Transcranial Magnetic Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: New Jersey Institute of TechnologyUniversity, hospital or other
Collaborators: Rutgers University, Northeastern University, Kessler Foundation
Study start: 24 Aug 2018 (actual)
Primary completion: 15 Aug 2024 (actual)
Study completion: 15 Aug 2024 (actual)
First posted: 26 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: Participants are assigned to one of four groups in parallel for the duration of the study.

Arm	Type	Receives
Early Robotic/VR Therapy (EVR)	Experimental	Device: 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.
Delayed Robotic/VR Therapy (DVR)	Experimental	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.
Usual Physical Therapy Care	No intervention	–Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Dose-Matched Usual Physical Therapy Care	Experimental	Behavioral: Dose-Matched Usual Physical Therapy CareSubjects in this group will receive state-of-art usual physical therapy/occupational therapy care plus an extra hour of state-of-art usual care.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early Robotic/VR Therapy (EVR)Also: NJIT-RAVR, NJIT-TrackGloveSubjects 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.	Device	Early Robotic/VR Therapy (EVR)
Dose-Matched Usual Physical Therapy CareSubjects 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.	Behavioural	Dose-Matched Usual Physical Therapy Care
Delayed Robotic/VR Therapy (DVR)Also: NJIT-RAVR, NJIT-TrackGloveSubjects 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.	Device	Delayed Robotic/VR Therapy (DVR)

Primary outcome

Action Research Arm Test (ARAT)
Time frame: 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.

82 secondary outcomes

Action Research Arm Test
Time frame: 6 months post stroke
Action Research Arm Test
Time frame: 1 month post treatment
Action Research Arm Test
Time frame: Immediately post treatment (ideally within 72 hours)
Action Research Arm Test
Time frame: Immediately prior to treatment (ideally within 72 hours)
Cortical Area Representation of the Finger-Hand Muscles
Time frame: 4 months post stroke
Cortical Area Representation of the Finger-Hand Muscles
Time frame: 6 months post stroke
Cortical Area Representation of the Finger-Hand Muscles
Time frame: 1 month post treatment
Cortical Area Representation of the Finger-Hand Muscles
Time frame: Immediately post treatment (ideally within 72 hours)
Cortical Area Representation of the Finger-Hand Muscles
Time frame: Immediately prior to treatment (ideally within 72 hours)
EEG-Based Measure of Resting State Brain Connectivity
Time frame: 4 months post stroke
EEG-Based Measure of Resting State Brain Connectivity
Time frame: 6 months post stroke
EEG-Based Measure of Resting State Brain Connectivity
Time frame: 1 month post treatment
EEG-Based Measure of Resting State Brain Connectivity
Time frame: Immediately post treatment (ideally within 72 hours)
EEG-Based Measure of Resting State Brain Connectivity
Time frame: Immediately prior to treatment (ideally within 72 hours)
EEG-Based Measure of Task-Based Brain Connectivity
Time frame: 4 months post stroke
EEG-Based Measure of Task-Based Brain Connectivity
Time frame: 6 months post stroke
EEG-Based Measure of Task-Based Brain Connectivity
Time frame: 1 month post treatment
EEG-Based Measure of Task-Based Brain Connectivity
Time frame: Immediately post treatment (ideally within 72 hours)
EEG-Based Measure of Task-Based Brain Connectivity
Time frame: Immediately prior to treatment (ideally within 72 hours)
Cerebral Oxygenation in Sensorimotor Cortex
Time frame: 4 months post stroke
Cerebral Oxygenation in Sensorimotor Cortex
Time frame: 6 months post stroke
Cerebral Oxygenation in Sensorimotor Cortex
Time frame: 1 month post treatment
Cerebral Oxygenation in Sensorimotor Cortex
Time frame: Immediately post treatment (ideally within 72 hours)
Cerebral Oxygenation in Sensorimotor Cortex
Time frame: Immediately prior to treatment (ideally within 72 hours)
Blocks and Box Test
Time frame: 4 months post stroke
Blocks and Box Test
Time frame: 6 months post stroke
Blocks and Box Test
Time frame: 1 month post treatment
Blocks and Box Test
Time frame: Immediately post treatment (ideally within 72 hours)
Blocks and Box Test
Time frame: Immediately prior to treatment (ideally within 72 hours)
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time frame: 4 months post stroke
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time frame: 6 months post stroke
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time frame: 1 month post treatment
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time frame: Immediately post treatment (ideally within 72 hours)
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time frame: Immediately prior to treatment (ideally within 72 hours)
Wolf Motor Function Test
Time frame: 4 months post stroke
Wolf Motor Function Test
Time frame: 6 months post stroke
Wolf Motor Function Test
Time frame: 1 month post treatment
Wolf Motor Function Test
Time frame: Immediately post treatment (ideally within 72 hours)
Wolf Motor Function Test
Time frame: Immediately prior to treatment (ideally within 72 hours)
Coordination between Hand Transport and Grasp during Reaching
Time frame: 4 months post stroke

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Derived from this study: PubMed 33324323Merians 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.
Individual participant dataSharing planned: Undecided

Related trials for Stroke, Acute

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sergei V Adamovich, PhD principal investigator

New Jersey Institute of Technology

Alma S Merians, PhD, PT principal investigator

Rutgers University

Karen Nolan, PhD principal investigator

Kessler Foundation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Action Research Arm Test (ARAT) (time frame: 4 months post stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03569059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.