Subacute StrokeNCT06752707
MiGo Tracker Remote Monitoring of Home Exercise After Stroke
A study testing MiGo Tracker and Conventional home exercise program in people with Subacute Stroke, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- MiGo Tracker and Conventional home exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rancho Research Institute, Inc
Downey, California, 90242
Nicole Bayus, 562-385-7049, NicoleB@ranchoresearch.org
Susan Shaw, MD
About this study
Official title: 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.
- Conditions
- Subacute Stroke
- Being tested
- MiGo Tracker, Conventional home exercise program
- Keywords
- Remote Therapeutic Monitoring, Stroke, Home Exercise Therapy, MiGo Tracker
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiGo TrackerDevice
Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
Conventional home exercise programOther
Exercise following printed sheets or booklet
| Study group | Role | What they receive |
|---|---|---|
| MiGo Tracker enabled RTM Program | Experimental | 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. Receives: Device: MiGo Tracker |
| Conventional Standard of Care | Active comparator | Participants will be assigned a home exercise regimen designed by a study therapist based on the individual participant's specific goals and abilities. Receives: Other: Conventional home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 months post stroke
Secondary outcomes (5)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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".
Measured: Baseline and 3 months post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start11 Jun 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flint Rehabilitation Devices, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Rancho Research Institute, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752707
- Sponsor's protocol ID
- R44AG090216-01
- Other IDs
- R44AG090216-01
- Status last verified
- Jul 2025
- First submitted
- 23 Dec 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke
- ClinicalTrials.gov ID
- NCT06752707
- Acronym / sponsor ID
- R44AG090216-01
- Conditions
- Subacute Stroke
- Keywords
- Remote Therapeutic Monitoring, Stroke, Home Exercise Therapy, MiGo Tracker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Flint Rehabilitation Devices, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Rancho Research Institute, Inc.
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiGo Tracker enabled RTM Program | Experimental | Device: MiGo TrackerParticipants 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. |
| Conventional Standard of Care | Active comparator | Other: Conventional home exercise programParticipants will be assigned a home exercise regimen designed by a study therapist based on the individual participant's specific goals and abilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiGo TrackerPerform home exercise sessions while wearing MiGo Tracker device that logs exercise data. | Device | MiGo Tracker enabled RTM Program |
| Conventional home exercise programExercise following printed sheets or booklet | Other | Conventional Standard of Care |
Primary outcome
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
5 secondary outcomes
Change in Action Research Arm Test from Baseline
Time frame: Baseline and 3 months post stroke
Change in Box and Blocks from Baseline
Time frame: Baseline and 3 months post stroke
Change in Motor Activity Log from Baseline
Time frame: Baseline and 3 months post stroke
Change in Modified Ashworth Spasticity Scale from Baseline
Time frame: Baseline and 3 months post stroke
Change in Visual Analog Pain Scale from Baseline
Time frame: Baseline and 3 months post stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Subacute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiGo Tracker and Conventional home exercise program in people with Subacute Stroke, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian M Russell, PhD (3392232676, irussell@flintrehab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Fugl-Meyer from Baseline (time frame: Baseline and 3 months post stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.