MiGo Tracker Remote Monitoring of Home Exercise After Stroke

NCT ID: NCT06752707

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Subacute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessor blinded

Study Groups

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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.

Group Type EXPERIMENTAL

MiGo Tracker

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Conventional home exercise program

Intervention Type OTHER

Exercise following printed sheets or booklet

Interventions

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MiGo Tracker

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

Intervention Type DEVICE

Conventional home exercise program

Exercise following printed sheets or booklet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Rancho Research Institute, Inc.

OTHER

Sponsor Role collaborator

Flint Rehabilitation Devices, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rancho Research Institute, Inc

Downey, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ian M Russell, PhD

Role: CONTACT

3392232676

Daniel Zondervan, PhD

Role: CONTACT

949-313-7322

Facility Contacts

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Nicole Bayus

Role: primary

562-385-7049

Other Identifiers

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R44AG090216-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R44AG090216-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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