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Behavioural Intervention
Neofect RAPAEL Smart Glove for Stroke (vREHAB Trial)
N/A
Waitlist Available
Led By Kara Flavin, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
vREHAB Trial Summary
This trial will help assess whether or not a virtual reality biofeedback system can promote recovery of distal arm and hand function in stroke patients.
Eligible Conditions
- Stroke
vREHAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in Functional Impairment, Jebsen Taylor Hand Function Test
Secondary outcome measures
Improvement in Functional Impairment, Upper Extremity Fugl-Meyer assessment
Persistence of treatment effects from 12-24 weeks in Jebsen Taylor hand function test
Persistence of treatment effects from 12-24 weeks in Upper Extremity Fugl-Meyer test
+2 morevREHAB Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Occupational Therapy + Smart GloveExperimental Treatment1 Intervention
Subjects randomized to this arm will be expected to use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
Group II: Standard Occupational TherapyActive Control1 Intervention
Subjects in the control arm will undergo standard of care occupational therapy as prescribed by their care team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neofect RAPAEL Smart Glove
2018
N/A
~50
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Who is running the clinical trial?
NEOFECT Rehabilitation SolutionsOTHER
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Stroke
100 Patients Enrolled for Stroke
Stanford UniversityLead Sponsor
2,385 Previous Clinical Trials
17,333,816 Total Patients Enrolled
25 Trials studying Stroke
56,415 Patients Enrolled for Stroke
Kara Flavin, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Stroke
20 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulty understanding and using language to the point that you cannot use the Smart Glove.You are experiencing severe pain that makes it difficult to use the Smart Glove or participate in upper body rehabilitation.You need to pour wine five times in the first minute while turning your wrist up and down.You have a neurological condition that affects your arm and hand function, such as Parkinson's disease or peripheral neuropathy.You need to be able to move your fingers without any difficulty and complete a 50-meter distance in a pool without touching the sides more than three times in the first three minutes.Move your wrist up and down without allowing gravity to affect it, as if you are scrubbing the floor. Repeat this 5 times in the first minute.You need to be able to move your wrist up and down without any difficulty and knock down three objects within one minute during a snowball fight game.You have difficulty thinking or understanding things that would prevent you from using the Smart Glove.You have weakness in one arm or hand caused by a stroke and need rehabilitation therapy for it.You have a diagnosis of ischemic or hemorrhagic stroke within 30 days prior to enrollment.You have a history of seizures triggered by visual stimuli.You have a mental health condition that may affect your ability to participate in the study.You must be able to play two out of four pre-selected games using a special glove. The games test your ability to move your wrist, fingers, and hand in different ways. For example, you may need to pour wine or scrub the floor using the glove. You will have a certain amount of time to complete each game with specific goals to pass.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Occupational Therapy + Smart Glove
- Group 2: Standard Occupational Therapy
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 recruitment ongoing for this trial?
"According to clinicaltrials.gov, this investigation is currently enrolling members. The trial was first launched on October 1st 2018 and the details were most recently revised on October 26th 2022."
Answered by AI
How many participants are currently being monitored in this trial?
"Affirmative. Clinicaltrials.gov offers evidence that this clinical trial is presently enrolling participants, with the original post being made on October 1st 2018 and last edited on October 26th 2022. Forty individuals are sought at one site for inclusion in the study."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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