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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
| Rancho Research Institute, Inc. | OTHER |
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The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FitMi Plus | Experimental | Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. |
|
| FitMi Basic | Active Comparator | Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitMi Plus | Device | A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Activity Log | A self-reported measure of the quality of movement and amount of use of the impaired upper extremity across a set of activities of daily living. Minimum value = 0, maximum value = 5, higher scores = better outcome | Baseline and One-Month Post-Treatment, at seven weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Extremity Fugl-Meyer | 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 One-Month Post-Treatment, at seven weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Reinkensmeyer, PhD | University of California, Irvine | Principal Investigator |
| Susan Shaw, MD | Rancho Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Research Institute, Inc | Downey | California | 90242 | United States | ||
| Human Neuroperformance Laboratory at University of California Irvine |
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| ID | Title | Description |
|---|---|---|
| FG000 | FitMi Plus | Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Plus: A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform. |
| FG001 | FitMi Basic | Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Basic: A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FitMi Plus | Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Plus: A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Motor Activity Log | A self-reported measure of the quality of movement and amount of use of the impaired upper extremity across a set of activities of daily living. Minimum value = 0, maximum value = 5, higher scores = better outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline and One-Month Post-Treatment, at seven weeks |
|
Adverse event data was collected from enrollment to one-month post-therapy, approximately 7 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FitMi Plus | Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Plus: A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Zondervan | Flint Rehab | 9493137322 | dzondervan@flintrehab.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2023 | Mar 6, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2021 | Dec 31, 2023 | ICF_001.pdf |
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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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| FitMi Basic | Device | A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. |
|
| Irvine |
| California |
| 926170000 |
| United States |
| BG001 | FitMi Basic | Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Basic: A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| FitMi Basic |
Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Basic: A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. |
|
|
|
| Secondary | Change in Upper Extremity Fugl-Meyer | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline and One-Month Post-Treatment, at seven weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | FitMi Basic | Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. FitMi Basic: A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |