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Rehab CARES In USA: Clinical Trial

NCT05542121 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-01-07

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Robot-Assisted Therapy with Rehab CARES system

60 min sessions; 3 sessions per week; for 4 weeks; Patients uses 1 or more affordable robots to exercise the UL with adaptive games assessments as OT; standard of care PT and SLP; Subjects' motor and cognitive impairment will be used to set the game and modes. The game parameters will be adjusted according to motor and cognitive impairment of that station's user while the controller will automatically adjust assisting or resisting torques experienced. The 60 minutes will be broken up into 15-minute training intervals.

OTHER

Standard of Care

60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP

Sponsors & Collaborators

  • Recupero Robotics LLC

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace)

    collaborator UNKNOWN

  • enAble Games LLC

    collaborator UNKNOWN

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Michelle J Johnson, PhD · University of Pennsylvania

  • Alwyn Johnson, MS · Recupero Robotics LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-08-30
Completion
2025-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542121 on ClinicalTrials.gov