FitMi Plus Home Therapy for Stroke Patients

Flint Rehabilitation Devices

Status: Completed

Conditions: Cerebral Stroke

Treatments: Device: FitMi Basic; Device: FitMi Plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03935425

1R44HD097803-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Experienced 1 or more strokes >6 months prior to enrollment
• Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
• Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale)
• Ability to understand the instructions to operate FitMi products

Exclusion criteria

• Lack of concurrent severe medical problems
• Lack of visual deficits
• Lack of severe neglect or apraxia
• No concurrent enrollment in another therapy study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

FitMi Plus

Experimental group

Description:

Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.

Treatment:

Device: FitMi Plus

FitMi Basic

Active Comparator group

Description:

Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.

Treatment:

Device: FitMi Basic