MiGo Tracker Remote Monitoring of Home Exercise After Stroke

NCT06752707 | Recruiting

• 1 other identifier: R44AG090216-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subacute Stroke

Keywords

Remote Therapeutic Monitoring; Stroke; Home Exercise Therapy; MiGo Tracker

Outcome Measures

Primary Outcomes (1)

• Change in Upper Extremity Fugl-Meyer from Baseline

  The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia. A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. Minimum value = 0, maximum value = 66, higher scores = better outcome

  Baseline and 3 months post stroke

Secondary Outcomes (5)

• Change in Action Research Arm Test from Baseline

  Baseline and 3 months post stroke

• Change in Box and Blocks from Baseline

  Baseline and 3 months post stroke

• Change in Motor Activity Log from Baseline

  Baseline and 3 months post stroke

• Change in Modified Ashworth Spasticity Scale from Baseline

  Baseline and 3 months post stroke

• Change in Visual Analog Pain Scale from Baseline

  Baseline and 3 months post stroke

Study Arms (2)

MiGo Tracker enabled RTM Program

EXPERIMENTAL

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.

Device: MiGo Tracker

Conventional Standard of Care

ACTIVE COMPARATOR

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

Other: Conventional home exercise program

Interventions

MiGo Tracker DEVICE

Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.

MiGo Tracker enabled RTM Program

Conventional home exercise program OTHER

Exercise following printed sheets or booklet

Conventional Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Flint Rehabilitation Devices, LLC: lead
• National Institute on Aging (NIA): collaborator
• Rancho Research Institute, Inc.: collaborator

Study Sites (1)

Rancho Research Institute, Inc

Downey, California, 90242, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ian M Russell, PhD

CONTACT

3392232676; irussell@flintrehab.com

Daniel Zondervan, PhD

CONTACT

949-313-7322; dzondervan@flintrehab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: June 11, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)