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

NCT ID: NCT03569059

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2024-08-15

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Robotic/VR Therapy (EVR)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Delayed Robotic/VR Therapy (DVR)

Intervention Type: DEVICE

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.

Usual Physical Therapy Care

Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dose-Matched Usual Physical Therapy Care

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.

Group Type: EXPERIMENTAL

Dose-Matched Usual Physical Therapy Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Other Intervention Names

NJIT-RAVR, NJIT-TrackGlove; NJIT-RAVR, NJIT-TrackGlove

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers University

OTHER

Sponsor Role: collaborator

Northeastern University

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: collaborator

New Jersey Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Sergei V. Adamovich PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergei V Adamovich, PhD

Role: PRINCIPAL_INVESTIGATOR

New Jersey Institute of Technology

Alma S Merians, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Karen Nolan, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Eugene Tunik, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

Kessler Institute for Rehabilitation

Saddle Brook, New Jersey, United States

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33324323 (View on PubMed)

Other Identifiers

R01HD058301

Identifier Type: NIH

Identifier Source: org_study_id

View Link