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

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.

Conditions

• Stroke, Acute

Interventions

DEVICE

Early Robotic/VR Therapy (EVR)

Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 5-30 days post stroke.

BEHAVIORAL

Dose-Matched Usual Physical Therapy Care

Subjects will perform state-of-art usual physical/occupational care and 10 days of one additional hour of state-of-art usual inpatient and/or outpatient physical therapy/occupational therapy.

DEVICE

Delayed Robotic/VR Therapy (DVR)

Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 31-60 days post stroke.

Sponsors & Collaborators

• Rutgers University

  collaborator OTHER

• Northeastern University

  collaborator OTHER

• Kessler Foundation

  collaborator OTHER

• New Jersey Institute of Technology

  lead OTHER

Principal Investigators

• Sergei V Adamovich, PhD · New Jersey Institute of Technology

• Alma S Merians, PhD, PT · Rutgers University

• Karen Nolan, PhD · Kessler Foundation

• Eugene Tunik, PhD, PT · Northeastern University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-24

Primary Completion

2024-08-15

Completion

2024-08-15

Countries

• United States

Study Locations