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NCT Number: NCT06752707

MiGo Tracker Remote Monitoring of Home Exercise 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Research Institute, Inc

Downey, California, 90242, United States

Location status: Recruiting

Location contact

Nicole Bayus

CONTACT

[email protected]

562-385-7049

Susan Shaw, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MiGo Tracker

Device

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

Conventional home exercise program

Other

Exercise following printed sheets or booklet

Primary outcomes

  1. Change in Upper Extremity Fugl-Meyer from Baseline

    Time frame: Baseline and 3 months post stroke

    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

Secondary outcomes

  1. Change in Action Research Arm Test from Baseline

    Time frame: Baseline and 3 months post stroke

    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

  2. Change in Box and Blocks from Baseline

    Time frame: Baseline and 3 months post stroke

    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.

  3. Change in Motor Activity Log from Baseline

    Time frame: Baseline and 3 months post stroke

    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

  4. Change in Modified Ashworth Spasticity Scale from Baseline

    Time frame: Baseline and 3 months post stroke

    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.

  5. Change in Visual Analog Pain Scale from Baseline

    Time frame: Baseline and 3 months post stroke

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Zondervan, PhD

CONTACT

[email protected]

949-313-7322

Ian M Russell, PhD

CONTACT

[email protected]

3392232676

Sponsors and collaborators

Lead sponsor

Flint Rehabilitation Devices, LLC

Industry

Collaborators

  • National Institute on Aging (NIA)
  • Rancho Research Institute, Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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