NCT03935425

FitMi Plus Home Therapy for Stroke Patients

FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Flint Rehabilitation Devices, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.

Conditions

• Cerebral Stroke

Interventions

Type	Name	Description
DEVICE	FitMi Plus	A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.
DEVICE	FitMi Basic	A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2019-05-02
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study