Cerebral StrokeNCT03935425
FitMi Plus Home Therapy for Stroke Patients
A study testing FitMi Plus and FitMi Basic in people with Cerebral Stroke, run by Flint Rehabilitation Devices, LLC at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- FitMi Plus and FitMi Basic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced 1 or more strokes >6 months prior to enrollment
- Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
- Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale)
- Ability to understand the instructions to operate FitMi products
Who cannot join
- Lack of concurrent severe medical problems
- Lack of visual deficits
- Lack of severe neglect or apraxia
- No concurrent enrollment in another therapy study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rancho Research Institute, Inc
Downey, California, 90242
Human Neuroperformance Laboratory at University of California Irvine
Irvine, California, 926170000
About this study
Official title: FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
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.
- Conditions
- Cerebral Stroke
- Being tested
- FitMi Plus, FitMi Basic
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitMi PlusDevice
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.
FitMi BasicDevice
A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FitMi Plus |
| 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. Receives: Device: FitMi Basic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and One-Month Post-Treatment, at seven weeks
Secondary outcomes (1)
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
Measured: Baseline and One-Month Post-Treatment, at seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start29 Nov 2021
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flint Rehabilitation Devices, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine, Rancho Research Institute, Inc.
- Responsible party
- Principal investigator, Flint Rehabilitation Devices, LLC, Flint Rehabilitation Devices, LLC
- Investigators
- David Reinkensmeyer, PhD, Principal investigator, University of California, IrvineSusan Shaw, MD, Principal investigator, Rancho Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935425
- Sponsor's protocol ID
- 1R44HD097803-01
- Status last verified
- Mar 2024
- First submitted
- 25 Apr 2019
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
- ClinicalTrials.gov ID
- NCT03935425
- Acronym / sponsor ID
- 1R44HD097803-01
- Conditions
- Cerebral Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Flint Rehabilitation Devices, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine, Rancho Research Institute, Inc.
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FitMi Plus | Experimental | Device: FitMi PlusParticipants 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 | Device: FitMi BasicParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experienced 1 or more strokes >6 months prior to enrollment
- Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
- Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale)
- Ability to understand the instructions to operate FitMi products
Key exclusion criteria (4 listed)
- Lack of concurrent severe medical problems
- Lack of visual deficits
- Lack of severe neglect or apraxia
- No concurrent enrollment in another therapy 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 |
|---|---|---|
| FitMi PlusA 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. | Device | FitMi Plus |
| FitMi BasicA wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. | Device | FitMi Basic |
Primary outcome
Change in Motor Activity Log
Time frame: Baseline and One-Month Post-Treatment, at seven weeks
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
1 secondary outcome
Change in Upper Extremity Fugl-Meyer
Time frame: Baseline and One-Month Post-Treatment, at seven weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cerebral Stroke
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, 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. This study is not recruiting at the moment.
David Reinkensmeyer, PhD principal investigator
University of California, Irvine
Susan Shaw, MD principal investigator
Rancho Research Institute, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitMi Plus and FitMi Basic in people with Cerebral Stroke, run by Flint Rehabilitation Devices, LLC at 2 sites 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 4 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Activity Log (time frame: Baseline and One-Month Post-Treatment, at seven weeks). 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 12 Mar 2024.