Robot-Assisted Therapy with Rehab CARES system for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia, Philadelphia, PA
Stroke+1 More
Robot-Assisted Therapy with Rehab CARES system - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.

Eligible Conditions

  • Stroke
  • Hemiplegia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 12 Secondary · Reporting Duration: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

Week 4
Change in Cognition
Change in Gross Hand Function
Change in Hand Dexterity
Change in Motor Control
at each of 12 therapy sessions
Exertion
Pain
at pre, at post-intervention (after 12 sessions), at follow-up
Active Joint Range of Motion (ROM)
Executive Function
Grip Strength
Motivation
Passive Joint Range of Motion (ROM)
Prediction of Cognitive Function
Prediction of Motor Function
Quality of life (Participation)
Quality of life (Satisfaction)
Upper Extremity Function
Usability
Visual Spatial Attention
Work Load

Trial Safety

Trial Design

2 Treatment Groups

Robot-Assisted Therapy with Rehab CARES system
1 of 2
Standard of Care
1 of 2
Experimental Treatment
Non-Treatment Group

36 Total Participants · 2 Treatment Groups

Primary Treatment: Robot-Assisted Therapy with Rehab CARES system · Has Placebo Group · N/A

Robot-Assisted Therapy with Rehab CARES system
Device
Experimental Group · 1 Intervention: Robot-Assisted Therapy with Rehab CARES system · Intervention Types: Device
Standard of Care
Other
PlaceboComparator Group · 1 Intervention: Standard of Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Closest Location: Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Stroke
0 CompletedClinical Trials

Who is running the clinical trial?

Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace)UNKNOWN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,785 Previous Clinical Trials
2,221,762 Total Patients Enrolled
66 Trials studying Stroke
4,826 Patients Enrolled for Stroke
enAble Games LLCUNKNOWN
Recupero Robotics LLCUNKNOWN
University of PennsylvaniaLead Sponsor
1,797 Previous Clinical Trials
36,106,526 Total Patients Enrolled
27 Trials studying Stroke
2,134 Patients Enrolled for Stroke
Michelle J Johnson, PhDPrincipal InvestigatorUniversity of Pennsylvania
11 Previous Clinical Trials
2,139 Total Patients Enrolled
9 Trials studying Stroke
284 Patients Enrolled for Stroke
Alwyn Johnson, MSPrincipal InvestigatorRecupero Robotics LLC

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a stroke and have been diagnosed with a stroke.
You have a manual muscle strength score of at least 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.