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Rehab CARES In USA: Clinical Trial

Rehab CARES In USA: Clinical Trial

Recruiting
55 years and older
All
Phase N/A

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Overview

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.

Description

In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.

Eligibility

Inclusion Criteria:

  • Age 55 and older (based on who is admitted to the CBR site)
  • >3 months post-stroke
  • Stroke diagnosis
  • Diagnosis of hemiparesis as a result of stroke (verified by radiology data)
  • Motor control score on Upper Extremity Fugl-Meyer scale > 15 and < 60;
  • Able to understand and speak
  • Upper arm manual muscle strength scores >1
  • Pain Scores < 8 based on NIH Pain Intensity Scale

Exclusion Criteria:

  • no cerebellum lesions due to stroke
  • severe cognitive function

Study details
    Stroke
    Hemiplegia

NCT05542121

University of Pennsylvania

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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