MiGo Tracker Remote Monitoring of Home Exercise After Stroke

MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Subacute Stroke
• Intervention / Treatment: Device: MiGo Tracker; Other: Conventional home exercise program

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Zondervan, PhD; Phone Number: 949-313-7322; Email: dzondervan@flintrehab.com
• Study Contact Backup: Name: Ian M Russell, PhD; Phone Number: 3392232676; Email: irussell@flintrehab.com

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Recruiting
      • Rancho Research Institute, Inc
      • Principal Investigator: Susan Shaw, MD
      • Contact: Nicole Bayus; Phone Number: 562-385-7049; Email: NicoleB@ranchoresearch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MiGo Tracker enabled RTM Program; 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; Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
Active Comparator: Conventional Standard of Care; 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; Exercise following printed sheets or booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Action Research Arm Test from Baseline	The Action Research Arm Test (ARAT) is a 19-item measure aimed at assessing functional performance of the upper extremity through observational means. The ARAT is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: (3) Performs test normally (2) Completes test, but takes abnormally long or has great difficulty (1) Performs test partially (0) Can perform no part of test	Baseline and 3 months post stroke
Change in Box and Blocks from Baseline	The Box and Block Test assesses unilateral gross manual dexterity. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.	Baseline and 3 months post stroke
Change in Motor Activity Log from Baseline	The MAL is a semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks. Items scored on a 6-point ordinal scale. Scoring on Amount of Use Scale: 0) The weaker arm was not sued at all for that activity (never) 1) very rarely 2) rarely 3) half pre-stroke 4)3/4 pre-stroke 5) normal. Quality of Movement Scale: 0) The weaker arm was not used at all for that activity (never) 1) very poor 2) poor 3) fair 4) almost normal 5) normal	Baseline and 3 months post stroke
Change in Modified Ashworth Spasticity Scale from Baseline	MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. A score of 1 indicates no resistance, and 5 indicates rigidity.	Baseline and 3 months post stroke
Change in Visual Analog Pain Scale from Baseline	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10cm line that represents a continuum between "no pain" and "worst pain".	Baseline and 3 months post stroke

Collaborators and Investigators

• Sponsor: Flint Rehabilitation Devices, LLC
• Collaborators: National Institute on Aging (NIA); Rancho Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Remote Therapeutic Monitoring; Home Exercise Therapy; MiGo Tracker
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: R44AG090216-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No