MiGo Tracker for Stroke Rehabilitation

Overseen By Daniel Zondervan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Flint Rehabilitation Devices, LLC

Disqualifiers: Age <18, Neurological, Severe medical, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the MiGo Tracker to determine if it improves recovery after a stroke. Participants will either use the MiGo Tracker, which tracks home exercises and includes weekly check-ins with a therapist, or follow a regular home exercise plan without tracking. The goal is to discover if the MiGo Tracker leads to better recovery three months post-stroke. Eligible participants must have experienced a stroke in the last 30 days and not have moderate to severe pain. As an unphased trial, this study provides a unique opportunity to contribute to innovative stroke recovery research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems that participants will continue with their usual post-stroke care, which may include existing medications.

What prior data suggests that the MiGo Tracker is safe for stroke rehabilitation?

Research shows that devices like the MiGo Tracker are being considered for stroke recovery. However, specific safety information about the MiGo Tracker is not available in the current research. The trial is labeled "Not Applicable" for phase, likely indicating that the MiGo Tracker is already considered safe as a wearable device. These devices are usually safe because they do not require implantation or surgery. Generally, people tolerate wearable devices well, but participants should inform the study team of any discomfort or issues during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MiGo Tracker because it introduces a new way of supporting stroke rehabilitation. Unlike the conventional standard of care, which relies on a therapist-designed home exercise regimen, the MiGo Tracker uses a device to log and track all home exercise sessions. This data is then uploaded to a dashboard for both the participant and the therapist to review. This approach enables regular, personalized feedback during weekly phone calls, potentially improving adherence and motivation. By leveraging technology to provide real-time insights and support, the MiGo Tracker aims to enhance the effectiveness of home-based rehabilitation exercises.

What evidence suggests that the MiGo Tracker is effective for stroke rehabilitation?

Research has shown that the MiGo Tracker, which participants in this trial may receive, can help monitor and improve movement recovery in stroke survivors. One study found that stroke patients using devices like the MiGo Tracker experienced better arm movement during rehabilitation. The MiGo Tracker accurately tracks movement quantity and quality, aiding in monitoring recovery progress. Early results suggest that using the MiGo Tracker might enhance adherence to home exercise routines and lead to improved health. If successful, this could result in better movement recovery for individuals three months after a stroke compared to those receiving conventional standard care in this trial. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently had a stroke and are in the subacute phase of recovery. They should be able to participate in home exercises and receive standard post-stroke care, including outpatient rehabilitation. Specific details about inclusion or exclusion criteria were not provided.

Inclusion Criteria

I had a stroke within the last 30 days.

My arm function score is between 6 and 55.

My pain level is 4 or lower on a scale of 10.

Exclusion Criteria

Other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

I have a neurological condition like Parkinson's Disease.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the MiGo Tracker RTM program or prescription of home exercises with no monitoring

12 weeks

Weekly phone calls for intervention group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MiGo Tracker

Trial Overview

The study is testing if using the MiGo Tracker for remote monitoring during home exercise programs improves motor recovery three months after a stroke compared to usual care without monitoring. Participants will be randomly placed into either the monitored group or a control group.

How Is the Trial Designed?

Group I: MiGo Tracker enabled RTM Program Experimental Treatment 1 Intervention

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 II: Conventional Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Flint Rehabilitation Devices, LLC

Lead Sponsor

Trials

7

Recruited

240+

Rancho Research Institute, Inc.

Collaborator

Trials

9

Recruited

560+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Stroke survivors recognize the potential of surface electromyography (sEMG) technology for aiding recovery, but they express a need for clearer interpretation of the data it provides to enhance its clinical application.

The study highlights that while sEMG can track small progress in recovery, its current design and user interface are seen as cumbersome, indicating a need for improvements to make it more user-friendly and effective in neurorehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's All Sort of Cool and Interesting…but What Do I Do With It?" A Qualitative Study of Stroke Survivors' Perceptions of Surface Electromyography. Feldner, HA., Papazian, C., Peters, K., et al.[2023]

In a randomized controlled trial involving 73 stroke patients, both interactive motion capture rehabilitation and usual care showed similar improvements in standing balance and other physical functions, indicating that the new technology is as effective as traditional methods.

The study found no adverse events during therapy, suggesting that the interactive rehabilitation approach is safe for patients recovering from stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial. Cannell, J., Jovic, E., Rathjen, A., et al.[2018]

This study will assess the impact of feedback from a Smart watch on daily physical activity levels in stroke rehabilitation patients, with a focus on improving mobility and functional activities over a 3-week period.

Participants will be randomly assigned to receive either regular activity feedback or no feedback while wearing the Smart watch, allowing researchers to evaluate the effectiveness of feedback on enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. Dong, Y., Steins, D., Sun, S., et al.[2022]

Robot-assisted therapy significantly improved motor function and arm activity in chronic stroke patients compared to a dose-matched active control therapy, as shown by various assessments including the Fugl-Meyer Assessment Scale and ABILHAND questionnaire.

The study involved 20 patients who received either therapy for 90-105 minutes daily over four weeks, demonstrating that robotic therapy can enhance both objective motor skills and patients' self-perception of their arm abilities long after their stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial. Liao, WW., Wu, CY., Hsieh, YW., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06752707

MiGo Tracker Remote Monitoring of Home Exercise After ...

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 ...

2.

withpower.com

withpower.com/trial/migo-tracker-for-stroke-rehabilitation-e9acc

MiGo Tracker for Stroke 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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9901039/

Wearable technology to capture arm use of stroke survivors ...

Similarly, a recent longitudinal study showed that 59% of stroke survivors that received outpatient rehabilitation care improved capacity for ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999324000947

A Novel, Wearable Inertial Measurement Unit for Stroke ...

MiGo is a unique system that accurately captures both UL and mobility movement quantity and quality in chronic stroke survivors.

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06752707/migo-tracker-remote-monitoring-of-home-exercise-after-stroke?activelyRecruiting=false&page=359&id=42&slug=cerebral-ischemia

MiGo Tracker Remote Monitoring of Home Exercise After ...

If successful, MiGo Tracker will lead to increased home exercise adherence and improved health outcomes for thousands of individuals following ...

6.

trialx.com

trialx.com/clinical-trials/listings/300204/migo-tracker-remote-monitoring-of-home-exercise-after-stroke/

MiGo Tracker Remote Monitoring of Home Exercise After ...

This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomized controlled trial with individuals with ...

7.

taggs.hhs.gov

taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R44AG090216&arg_ProgOfficeCode=102

Award Information | HHS TAGGS

MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke. Award Number: R44AG090216. ORGANIZATION: NATIONAL INSTITUTE ON ...