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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG090216-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Rancho Research Institute, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiGo Tracker | Device | Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 3 months post stroke |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ian M Russell, PhD | Contact | 3392232676 | irussell@flintrehab.com | |
| Daniel Zondervan, PhD | Contact | 949-313-7322 | dzondervan@flintrehab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Research Institute, Inc | Recruiting | Downey | California | 90242 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Assessor blinded
| Conventional home exercise program | Other | Exercise following printed sheets or booklet |
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| 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. | 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 | 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. | 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". | Baseline and 3 months post stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |