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Recruiting NCT06752707

MiGo Tracker Remote Monitoring of Home Exercise After Stroke

No phase Interventional Subacute Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MiGo Tracker, Conventional home exercise program.
Who it may be relevant to
Registry conditions: Subacute Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device MiGo Tracker
    Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
  • Other Conventional home exercise program
    Exercise following printed sheets or booklet

Primary outcome measures

  • Change in Upper Extremity Fugl-Meyer from Baseline [Time frame: Baseline and 3 months post stroke]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rancho Research Institute, Inc — Downey

Identifiers

NCT: NCT06752707 · R44AG090216-01 · R44AG090216-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗