StrokeSENS-AGNCT06234878
REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG)
A study testing REEV SENSE and Motion capture system in people with Stroke and Gait Disorders, Neurologic, run by REEV LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment. REEV SENSE is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- REEV SENSE and Motion capture system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-stroke gait disorder.
- Must be able to walk independently with or without the support of a cane or rollator.
- History of stroke more than six months ago.
- Be 18 years of age or older.
Who cannot join
- Subject unable to give consent.
- Subject unable to understand the tests.
Trial locations and contacts
1 site in 1 country.
United States1 site
MIT Center for Clinical and Translational Research
Cambridge, Massachusetts, 02139
About this study
Official title: Validation of REEV SENSE Biomarkers Precision for Gait Analysis in Subjects With Post-stroke Gait Impairment
The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.
REEV SENSE is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine.
The reference method for performance comparison will be motion capture.
Read the detailed description
REEV SENSE is a medical device, with pending FDA and CE certifications in class 1. It is a connected gait tracker set primarily on the leg or foot, and eventually on lower limb locations. It contains an accelerometer, a certified standard battery and motion analysis algorithms that will rapidly compute easy-to-use walking analyses accessible to healthcare professionals on a mobile app.
Standard gait biomarkers such as velocity, stride length, or stance and swing times will be computed. However, REEV has also developed a new biomarker, the knee position predictor (KPP), which will provide a more accurate quantification of each individual gait profile.
The present REEV SENSE study is the first to test subjects with a pathological context, i.e. with post-stroke ambulation deficit. Performance of REEV SENSE has already been established in healthy volunteers in comparison to the reference motion capture system, indicating good technical and metrological performance.
The study will take place at the MIT Center for Clinical and Translational Research (CCTR), a reference center with a fully equipped gait lab.
Each participating volunteer will be equipped with REEV SENSE and the reference motion capture system. The participant will be asked to walk at a comfortable self selected pace for about 15 minutes back and forth along a 10m walkway. He or she may rest at any time during the walking session. REEV SENSE and motion capture data will be recorded automatically and simultaneously during the same walking session.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- REEV SENSE, Motion capture system
- Keywords
- Stroke, Gait analysis, Accelerometer, Gait impairment
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REEV SENSEDevice
Gait analysis with an Inertial Measurement Unit (IMU) sensor
Motion capture systemDevice
Gait analysis with reflective markers and pressure sensors
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis | Experimental | Gait analysis with the investigational and the reference devices Receives: Device: REEV SENSE; Device: Motion capture system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed measure precision
Comparison of walking speed measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Secondary outcomes (8)
KPP (Knee Position Predictor) measure precision = precision of the predicted angle of knee sagittal flexion in the next 200ms
Comparison of KPP measured with REEV SENSE with reference method.
Measured: Throughout study completion (an average of 2h)
Walking cadence measure precision = precision of the number of steps per minute
Comparison of walking cadence measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Stride length measure precision
Comparison of stride length measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Swing time measure precision
Comparison of swing time measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Stance time measure precision
Comparison of stance time measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Stance symmetry measure precision = precision of the % of unilateral stance time predominance (right or left) compared to total bilateral stance time (right and left)
Comparison of stance symmetry measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Knee flexion angle measure precision in sagittal plan
Comparison of knee flexion measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Ankle flexion angle measure precision in sagittal plan
Comparison of ankle flexion angle measured with REEV SENSE with reference method
Measured: Throughout study completion (an average of 2h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start8 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- REEV LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234878
- Sponsor's protocol ID
- REEV-RS-01
- Acronym
- SENS-AG
- Status last verified
- Apr 2025
- First submitted
- 15 Dec 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of REEV SENSE Biomarkers Precision for Gait Analysis in Subjects With Post-stroke Gait Impairment
- ClinicalTrials.gov ID
- NCT06234878
- Acronym / sponsor ID
- SENS-AG / REEV-RS-01
- Conditions
- Stroke, Gait Disorders, Neurologic
- Keywords
- Stroke, Gait analysis, Accelerometer, Gait impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- REEV LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.
REEV SENSE is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine.
The reference method for performance comparison will be motion capture.
Detailed description
REEV SENSE is a medical device, with pending FDA and CE certifications in class 1. It is a connected gait tracker set primarily on the leg or foot, and eventually on lower limb locations. It contains an accelerometer, a certified standard battery and motion analysis algorithms that will rapidly compute easy-to-use walking analyses accessible to healthcare professionals on a mobile app.
Standard gait biomarkers such as velocity, stride length, or stance and swing times will be computed. However, REEV has also developed a new biomarker, the knee position predictor (KPP), which will provide a more accurate quantification of each individual gait profile.
The present REEV SENSE study is the first to test subjects with a pathological context, i.e. with post-stroke ambulation deficit. Performance of REEV SENSE has already been established in healthy volunteers in comparison to the reference motion capture system, indicating good technical and metrological performance.
The study will take place at the MIT Center for Clinical and Translational Research (CCTR), a reference center with a fully equipped gait lab.
Each participating volunteer will be equipped with REEV SENSE and the reference motion capture system. The participant will be asked to walk at a comfortable self selected pace for about 15 minutes back and forth along a 10m walkway. He or she may rest at any time during the walking session. REEV SENSE and motion capture data will be recorded automatically and simultaneously during the same walking session.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait analysis | Experimental | Device: REEV SENSE, Device: Motion capture systemGait analysis with the investigational and the reference devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-stroke gait disorder.
- Must be able to walk independently with or without the support of a cane or rollator.
- History of stroke more than six months ago.
- Be 18 years of age or older.
Key exclusion criteria (2 listed)
- Subject unable to give consent.
- Subject unable to understand the tests.
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 |
|---|---|---|
| REEV SENSEGait analysis with an Inertial Measurement Unit (IMU) sensor | Device | Gait analysis |
| Motion capture systemGait analysis with reflective markers and pressure sensors | Device | Gait analysis |
Primary outcome
Walking speed measure precision
Time frame: Throughout study completion (an average of 2h)
Comparison of walking speed measured with REEV SENSE with reference method
8 secondary outcomes
KPP (Knee Position Predictor) measure precision = precision of the predicted angle of knee sagittal flexion in the next 200ms
Time frame: Throughout study completion (an average of 2h)
Walking cadence measure precision = precision of the number of steps per minute
Time frame: Throughout study completion (an average of 2h)
Stride length measure precision
Time frame: Throughout study completion (an average of 2h)
Swing time measure precision
Time frame: Throughout study completion (an average of 2h)
Stance time measure precision
Time frame: Throughout study completion (an average of 2h)
Stance symmetry measure precision = precision of the % of unilateral stance time predominance (right or left) compared to total bilateral stance time (right and left)
Time frame: Throughout study completion (an average of 2h)
Knee flexion angle measure precision in sagittal plan
Time frame: Throughout study completion (an average of 2h)
Ankle flexion angle measure precision in sagittal plan
Time frame: Throughout study completion (an average of 2h)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REEV SENSE and Motion capture system in people with Stroke and Gait Disorders, Neurologic, run by REEV LLC at 1 site 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 2 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Walking speed measure precision (time frame: Throughout study completion (an average of 2h)). 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 15 Apr 2025.