MiGo Tracker Remote Monitoring of Home Exercise After Stroke

Flint Rehabilitation Devices

Status: Enrolling

Conditions: Subacute Stroke

Treatments: Other: Conventional home exercise program; Device: MiGo Tracker

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06752707

R44AG090216-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomized controlled trial with individuals with subacute stroke (N=50). Participants will be randomly assigned to either the MiGo Tracker RTM program (intervention group) or prescription of home exercises with no monitoring (usual care/control group). All participants will still receive usual post-stroke care, including outpatient rehabilitation. The main question this study aims to answer is: Does a MiGo Tracker RTM program lead to significantly greater motor recovery at three-months post stroke than the usual care group. If successful, MiGo Tracker will lead to increased home exercise adherence and improved health outcomes for thousands of individuals following stroke.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Experienced one or more strokes less than one month (30 days) prior
• Upper Extremity Fugl-Meyer Score > 5 and <= 55 out of 66
• Absence of moderate to severe pain (<= 4 on the 10 point visual-analog pain scale)

Exclusion criteria

• age <18 years old
• Unable to follow 2-step commands
• Other neurological diagnosis (e.g. Parkinson's Disease)
• Other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

MiGo Tracker enabled RTM Program

Experimental group

Description:

Participants will be provided a MiGo Tracker device which will log all home exercise sessions and uploaded to the MiGo-RTM dashboard. The supervising study therapist will conduct weekly phone calls with each participant where they review exercise metrics and assist with any barriers or issues.

Treatment:

Device: MiGo Tracker

Conventional Standard of Care

Active Comparator group

Description:

Participants will be assigned a home exercise regimen designed by a study therapist based on the individual participant's specific goals and abilities.

Treatment:

Other: Conventional home exercise program