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

Trial Summary

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 data supports the effectiveness of the MiGo Tracker treatment for stroke rehabilitation?

Research suggests that feedback on physical activity using devices like smartwatches can increase activity levels in stroke patients during rehabilitation, which may help improve mobility. Additionally, sensor-based rehabilitation technologies have shown promising results in enhancing functional recovery in stroke patients. ^{1 2 3 4 5}

Is the MiGo Tracker safe for use in humans?

The research articles reviewed do not provide specific safety data for the MiGo Tracker or similar wearable devices in humans. They focus on the use and effectiveness of wearable technology for tracking mobility and activity in stroke patients, but do not mention any safety concerns. ^{2 6 7 8 9}

How does the MiGo Tracker treatment differ from other stroke rehabilitation treatments?

The MiGo Tracker is unique because it uses wearable technology to continuously monitor physical activity in stroke survivors, allowing for personalized and home-based rehabilitation. This approach is different from traditional therapies that often require in-person sessions and may not provide continuous feedback on progress. ^{6 10 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2022]

2. England 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. [2022]

3. England 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of treatment effects after sensor- and robot-based task-oriented arm training in highly functional stroke patients. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Designing Ecological Auditory Feedback on Lower Limb Kinematics for Hemiparetic Gait Training. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Clinicians' perceptions of a potential wearable device for capturing upper limb activity post-stroke: a qualitative focus group study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Utilization of wearable technology to assess gait and mobility post-stroke: a systematic review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Validity and reliability of inertial measurement units for gait assessment within a post stroke population. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Using an Accelerometer-Based Step Counter in Post-Stroke Patients: Validation of a Low-Cost Tool. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Accuracy of Commercially Available Fitness Trackers in Patients after Stroke. [2022]

11. Switzerland 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Application of home-based wearable technologies in physical rehabilitation for stroke: A scoping review. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

DoMoMEA: a Home-Based Telerehabilitation System for Stroke Patients. [2020]