NCT05542121

Rehab CARES In USA: Clinical Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke
• Hemiplegia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2022-09-15
• Last updated: 2026-01-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study