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Robotic Rehabilitation
Robotic/Virtual Reality Therapy for Stroke (RAVR Trial)
N/A
Recruiting
Led By AM Barrett, MD
Research Sponsored by New Jersey Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sufficient cognitive function to follow instructions
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months post stroke
Awards & highlights
RAVR Trial Summary
This trial will investigate whether intensive, high dosage task and impairment based training using haptic robots and virtual reality simulations can improve motor skills in adults who have had a stroke.
Who is the study for?
This trial is for individuals who have had a stroke within the last 7 to 30 days, can follow instructions, and have limited hand movement (Fugl-Meyer score ≤49/66). They must also be able to feel light touch and not have other serious illnesses or conditions that could interfere with therapy.Check my eligibility
What is being tested?
The study compares early versus delayed rehabilitation using robots and virtual reality (VR) to improve hand function after stroke. It tests if intensive training during a critical period of brain recovery can better restore motor skills.See study design
What are the potential side effects?
While specific side effects are not listed, participants may experience fatigue or discomfort from intensive therapy sessions. The robotic/VR system is designed to adapt to individual limitations which should minimize strain.
RAVR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and follow instructions.
RAVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months post stroke
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months post stroke
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Action Research Arm Test (ARAT)
Secondary outcome measures
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Upper arm
+18 moreRAVR Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Early Robotic/VR Therapy (EVR)Experimental Treatment1 Intervention
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 II: Dose-Matched Usual Physical Therapy CareExperimental Treatment1 Intervention
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 III: Delayed Robotic/VR Therapy (DVR)Experimental Treatment1 Intervention
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 IV: Usual Physical Therapy CareActive Control1 Intervention
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
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Who is running the clinical trial?
Northeastern UniversityOTHER
88 Previous Clinical Trials
61,196 Total Patients Enrolled
4 Trials studying Stroke
432 Patients Enrolled for Stroke
Kessler FoundationOTHER
173 Previous Clinical Trials
10,594 Total Patients Enrolled
26 Trials studying Stroke
2,359 Patients Enrolled for Stroke
New Jersey Institute of TechnologyLead Sponsor
8 Previous Clinical Trials
829 Total Patients Enrolled
2 Trials studying Stroke
87 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke or another neurological condition that still affects my movement.I have difficulty understanding spoken or written language.I have difficulty noticing things on one side of my body or severe loss of body awareness.I have no major health issues besides my current condition.I can understand and follow instructions.You were not able to do things on your own before having a stroke.I have severe arthritis that limits my arm and hand movements.You have a score of 1 or higher on the limb ataxia test conducted by the NIH Stroke Scale.I had a stroke on one side of my brain between 7 to 30 days ago.Your Fugl-Meyer score is less than 49 out of 66.You can feel touch on your skin with a special tool.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Physical Therapy Care
- Group 2: Dose-Matched Usual Physical Therapy Care
- Group 3: Early Robotic/VR Therapy (EVR)
- Group 4: Delayed Robotic/VR Therapy (DVR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently a call for volunteers to participate in this clinical trial?
"According to clinicaltrials.gov, the trial remains open and is actively recruiting participants; it was posted on August 24th 2018 with a most recent update occurring September 29th 2021."
Answered by AI
Is the age limit for participation in this trial restricted to those over 25?
"Entrants to this medical trial must be between 30 and 80 years old."
Answered by AI
What is the aggregate number of participants engaged in this experiment?
"Affirmative. The information accessible on clinicaltrials.gov implies that this study is presently in the process of recruiting individuals, having first been posted on August 24th 2018 and recently updated September 29th 2021. 120 participants are expected to join from 2 separate locations."
Answered by AI
Could I be accepted to participate in this experiment?
"This clinical trial is enrolling 120 participants aged between 30 and 80 that have sustained a unilateral stroke within the past month. To qualify for this study, patients must demonstrate intact sensory nerve conduction (e.g. able to detect <4.17 N of pressure with Semmes- Weinstein nylon filaments), possess sufficient cognitive capacity to understand instructions, and score ≤49/66 on the Fugl-Meyer assessment scale."
Answered by AI
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