MiGo Tracker Remote Monitoring of Home Exercise After Stroke
ConditionSubacute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlint Rehabilitation Devices, LLC
About 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 does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
MiGo Tracker
DevicePerform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
Conventional home exercise program
Other interventionExercise following printed sheets or booklet
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: MiGo Tracker enabled RTM ProgramExperimental treatment 1 intervention
Group B: Conventional Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and 3 months post strokeSecondary outcomes
1
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
Time frame
Baseline and 3 months post stroke2
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.
Time frame
Baseline and 3 months post stroke3
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
Time frame
Baseline and 3 months post stroke4
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.
Time frame
Baseline and 3 months post strokeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Flint Rehabilitation Devices, LLC
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Rancho Research Institute, Inc.
Collaborator
Source ClinicalTrials.gov