Clinical trial NCT03569059: Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)
Official title: Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: Stroke
Virtual Environment
Robotics
Upper Extremity
Hand
Transcranial Magnetic Stimulation
Lead sponsor: New Jersey Institute of Technology
Sponsor class: OTHER
Collaborators: name: Rutgers University
name: Northeastern University
name: Kessler Foundation
First posted: 2018-06-26
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of four groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: This study investigates the effects of intensive, high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations. There is a time-limited period of post-ischemic heightened neuronal plasticity during which intensive training may optimally affect the recovery of motor skills, indicating that the timing of rehabilitation is as important as the dosing. However, recent literature indicates a controversy regarding both the value of intensive, high dosage as well as the optimal timing for therapy in the first two months after stroke. This study is designed to empirically investigate this controversy. It is evident that providing additional, intensive therapy during the acute rehabilitation stay is more complicated to implement and difficult for patients to tolerate, than initiating it in the outpatient setting, immediately after discharge. The robotic/VR system is specifically designed to deliver hand and arm training when motion and strength are limited, using adaptive algorithms to drive individual finger movement, gain adaptation and workspace modification to increase finger and arm range of motion, and haptic and visual feedback from mirrored movements to reinforce motor networks in the lesioned hemisphere.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 4 months post stroke
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: 6 months post stroke
measure: Action Research Arm Test
timeFrame: 1 month post treatment
measure: Action Research Arm Test
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Action Research Arm Test
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Cortical Area Representation of the Finger-Hand Muscles
timeFrame: 4 months post stroke
measure: Cortical Area Representation of the Finger-Hand Muscles
timeFrame: 6 months post stroke
measure: Cortical Area Representation of the Finger-Hand Muscles
timeFrame: 1 month post treatment
measure: Cortical Area Representation of the Finger-Hand Muscles
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Cortical Area Representation of the Finger-Hand Muscles
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: EEG-Based Measure of Resting State Brain Connectivity
timeFrame: 4 months post stroke
measure: EEG-Based Measure of Resting State Brain Connectivity
timeFrame: 6 months post stroke
measure: EEG-Based Measure of Resting State Brain Connectivity
timeFrame: 1 month post treatment
measure: EEG-Based Measure of Resting State Brain Connectivity
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: EEG-Based Measure of Resting State Brain Connectivity
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: EEG-Based Measure of Task-Based Brain Connectivity
timeFrame: 4 months post stroke
measure: EEG-Based Measure of Task-Based Brain Connectivity
timeFrame: 6 months post stroke
measure: EEG-Based Measure of Task-Based Brain Connectivity
timeFrame: 1 month post treatment
measure: EEG-Based Measure of Task-Based Brain Connectivity
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: EEG-Based Measure of Task-Based Brain Connectivity
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Cerebral Oxygenation in Sensorimotor Cortex
timeFrame: 4 months post stroke
measure: Cerebral Oxygenation in Sensorimotor Cortex
timeFrame: 6 months post stroke
measure: Cerebral Oxygenation in Sensorimotor Cortex
timeFrame: 1 month post treatment
measure: Cerebral Oxygenation in Sensorimotor Cortex
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Cerebral Oxygenation in Sensorimotor Cortex
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Blocks and Box Test
timeFrame: 4 months post stroke
measure: Blocks and Box Test
timeFrame: 6 months post stroke
measure: Blocks and Box Test
timeFrame: 1 month post treatment
measure: Blocks and Box Test
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Blocks and Box Test
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
timeFrame: 4 months post stroke
measure: Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
timeFrame: 6 months post stroke
measure: Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
timeFrame: 1 month post treatment
measure: Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Wolf Motor Function Test
timeFrame: 4 months post stroke
measure: Wolf Motor Function Test
timeFrame: 6 months post stroke
measure: Wolf Motor Function Test
timeFrame: 1 month post treatment
measure: Wolf Motor Function Test
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Wolf Motor Function Test
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Coordination between Hand Transport and Grasp during Reaching
timeFrame: 4 months post stroke
measure: Coordination between Hand Transport and Grasp during Reaching
timeFrame: 6 months post stroke
measure: Coordination between Hand Transport and Grasp during Reaching
timeFrame: 1 month post treatment
measure: Coordination between Hand Transport and Grasp during Reaching
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Coordination between Hand Transport and Grasp during Reaching
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Arm Range of Motion
timeFrame: 4 months post stroke
measure: Arm Range of Motion
timeFrame: 6 months post stroke
measure: Arm Range of Motion
timeFrame: 1 month post treatment
measure: Arm Range of Motion
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Arm Range of Motion
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
timeFrame: 4 months post stroke
measure: Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
timeFrame: 6 months post stroke
measure: Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
timeFrame: 1 month post treatment
measure: Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Maximum Thumb and Index Fingertip Pinch Force
timeFrame: 4 months post stroke
measure: Maximum Thumb and Index Fingertip Pinch Force
timeFrame: 6 months post stroke
measure: Maximum Thumb and Index Fingertip Pinch Force
timeFrame: 1 month post treatment
measure: Maximum Thumb and Index Fingertip Pinch Force
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Maximum Thumb and Index Fingertip Pinch Force
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
timeFrame: 4 months post stroke
measure: Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
timeFrame: 6 months post stroke
measure: Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
timeFrame: 1 month post treatment
measure: Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Measurement of Daily Use of Upper Extremity
timeFrame: 4 months post stroke
measure: Measurement of Daily Use of Upper Extremity
timeFrame: 6 months post stroke
measure: Measurement of Daily Use of Upper Extremity
timeFrame: 1 month post treatment
measure: EuroQol
timeFrame: 4 months post stroke
measure: EuroQol
timeFrame: 6 months post stroke
measure: EuroQol
timeFrame: 1 month post treatment
measure: EuroQol
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: EuroQol
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 4 months post stroke
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 6 months post stroke
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 1 month post treatment
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Immediately post treatment (ideally within 72 hours)
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Immediately prior to treatment (ideally within 72 hours)
measure: Change in Robot-Based Measure of Elbow-Shoulder Coordination during Reaching
timeFrame: Day 1 and and Day 10 of treatment for EVR and DVR groups
measure: Change in Robot-Based Measure of Maximum Seated Workspace during Reaching
timeFrame: Day 1 and and Day 10 of treatment for EVR and DVR groups
measure: Change in Robot-Based Measure of Movement Speed during Arm Reaching
timeFrame: Day 1 and and Day 10 of treatment for EVR and DVR groups
measure: Change in Robot-Based Measure of Movement Speed during Targeted Finger Motion
timeFrame: Day 1 and and Day 10 of treatment for EVR and DVR groups
measure: Patient's Structured Subjective Assessment
timeFrame: Immediately post treatment (ideally within 72 hours) for EVR and DVR groups
Other outcomes:
Locations:
city: Saddle Brook
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: New Jersey Institute of Technology
name: Sergei V Adamovich, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Alma S Merians, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Foundation
name: Karen Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: Eugene Tunik, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.