NCT Number: NCT03569059
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.
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Notify Me30 year–80 year
All sexes
Interventional
Not applicable
Kessler Institute for Rehabilitation, Saddle Brook, New Jersey, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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
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.
Time frame: 6 months post stroke
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time frame: 1 month post treatment
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time frame: Immediately post treatment (ideally within 72 hours)
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time frame: Immediately prior to treatment (ideally within 72 hours)
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time frame: 6 months post stroke
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time frame: 1 month post treatment
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time frame: Immediately post treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time frame: Immediately prior to treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time frame: 4 months post stroke
Task-based connectivity will be evaluated.
Time frame: 6 months post stroke
Electroencephalography will be used to evaluate task-based brain connectivity.
Time frame: 1 month post treatment
Electroencephalography will be used to evaluate task-based brain connectivity.
Time frame: Immediately post treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate task-based brain connectivity.
Time frame: Immediately prior to treatment (ideally within 72 hours)
Electroencephalography will be used to evaluate task-based brain connectivity.
Time frame: 4 months post stroke
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time frame: 6 months post stroke
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time frame: 1 month post treatment
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time frame: Immediately post treatment (ideally within 72 hours)
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time frame: Immediately prior to treatment (ideally within 72 hours)
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
Active range of motion for fingers, wrist, elbow and shoulder.
Time frame: 6 months post stroke
Active range of motion for fingers, wrist, elbow and shoulder.
Time frame: 1 month post treatment
Active range of motion for fingers, wrist, elbow and shoulder.
Time frame: Immediately post treatment (ideally within 72 hours)
Active range of motion for fingers, wrist, elbow and shoulder.
Time frame: Immediately prior to treatment (ideally within 72 hours)
Active range of motion for fingers, wrist, elbow and shoulder.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time frame: 6 months post stroke
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time frame: 1 month post treatment
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time frame: Immediately post treatment (ideally within 72 hours)
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time frame: Immediately prior to treatment (ideally within 72 hours)
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Time frame: 6 months post stroke
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Time frame: 1 month post treatment
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: 4 months post stroke
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.
Time frame: 6 months post stroke
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.
Time frame: 1 month post treatment
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.
Time frame: Immediately post treatment (ideally within 72 hours)
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.
Time frame: Immediately prior to treatment (ideally within 72 hours)
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.
Time frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
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.
Time frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
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.
Time frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
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.
Time frame: Day 1 and and Day 10 of treatment for EVR and DVR groups
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.
Time frame: Immediately post treatment (ideally within 72 hours) for EVR and DVR groups
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.
New Jersey Institute of Technology
Other
Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments
Acronym: RAVR
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