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

NCT03569059 | Completed DMC

• 1 other identifier: R01HD058301
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute

Keywords

Stroke; Virtual Environment; Robotics; Upper Extremity; Hand; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test (ARAT)

  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.

  4 months post stroke

Secondary Outcomes (82)

• Action Research Arm Test

  6 months post stroke

• Action Research Arm Test

  1 month post treatment

• Action Research Arm Test

  Immediately post treatment (ideally within 72 hours)

• Action Research Arm Test

  Immediately prior to treatment (ideally within 72 hours)

• Cortical Area Representation of the Finger-Hand Muscles

  4 months post stroke

Study Arms (4)

Early Robotic/VR Therapy (EVR)

EXPERIMENTAL

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.

Device: Early Robotic/VR Therapy (EVR)

Delayed Robotic/VR Therapy (DVR)

EXPERIMENTAL

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.

Device: Delayed Robotic/VR Therapy (DVR)

Usual Physical Therapy Care

NO INTERVENTION

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

Dose-Matched Usual Physical Therapy Care

EXPERIMENTAL

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.

Behavioral: Dose-Matched Usual Physical Therapy Care

Interventions

Early Robotic/VR Therapy (EVR) 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.

Also known as: NJIT-RAVR, NJIT-TrackGlove

Early Robotic/VR Therapy (EVR)

Dose-Matched Usual Physical Therapy Care 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.

Dose-Matched Usual Physical Therapy Care

Delayed Robotic/VR Therapy (DVR) 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.

Also known as: NJIT-RAVR, NJIT-TrackGlove

Delayed Robotic/VR Therapy (DVR)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Jersey Institute of Technology: lead
• Rutgers University: collaborator
• Northeastern University: collaborator
• Kessler Foundation: collaborator

Study Sites (2)

Kessler Institute for Rehabilitation

Saddle Brook, New Jersey, 07663, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

• 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.

  PMID: 33324323 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sergei V Adamovich, PhD

  New Jersey Institute of Technology

  PRINCIPAL INVESTIGATOR

• Alma S Merians, PhD, PT

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Karen Nolan, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

• Eugene Tunik, PhD, PT

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to one of four groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 26, 2018
• Study Start: August 24, 2018
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

US (2)