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

N

New Jersey Institute of Technology (NJIT)

Status

Completed

Conditions

Stroke, Acute

Treatments

Behavioral: Dose-Matched Usual Physical Therapy Care
Device: Early Robotic/VR Therapy (EVR)
Device: Delayed Robotic/VR Therapy (DVR)

Study type

Interventional

Funder types

Other

Identifiers

NCT03569059
R01HD058301

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

115 participants in 4 patient groups

Early Robotic/VR Therapy (EVR)
Experimental group
Description:
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.
Treatment:
Device: Early Robotic/VR Therapy (EVR)
Delayed Robotic/VR Therapy (DVR)
Experimental group
Description:
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.
Treatment:
Device: Delayed Robotic/VR Therapy (DVR)
Usual Physical Therapy Care
No Intervention group
Description:
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Dose-Matched Usual Physical Therapy Care
Experimental group
Description:
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.
Treatment:
Behavioral: Dose-Matched Usual Physical Therapy Care

Trial contacts and locations

2

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Central trial contact

Emma Kaplan, MS; Sergei V Adamovich, PhD

Data sourced from clinicaltrials.gov

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