Rehab CARES In USA: Clinical Trial

Stroke Clinical Trial

Official title: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

• NCT number: NCT05542121
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Pamela Z Cacchione, PhD, RN
• Phone: 215-259-0428
• Email: pamelaca@nursing.upenn.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Completion date: August 30, 2024