NCT06234878

Brief 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. The reference method for performance comparison will be motion capture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

December 15, 2023

Last Update Submit

April 10, 2025

Conditions

StrokeGait Disorders, Neurologic

Keywords

StrokeGait analysisAccelerometerGait impairment

Outcome Measures

Primary Outcomes (1)

  • Walking speed measure precision

    Comparison of walking speed measured with REEV SENSE with reference method

    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

    Throughout study completion (an average of 2h)

  • Walking cadence measure precision = precision of the number of steps per minute

    Throughout study completion (an average of 2h)

  • Stride length measure precision

    Throughout study completion (an average of 2h)

  • Swing time measure precision

    Throughout study completion (an average of 2h)

  • Stance time measure precision

    Throughout study completion (an average of 2h)

  • +3 more secondary outcomes

Study Arms (1)

Gait analysis

EXPERIMENTAL

Gait analysis with the investigational and the reference devices

Device: REEV SENSEDevice: Motion capture system

Interventions

REEV SENSEDEVICE

Gait analysis with an Inertial Measurement Unit (IMU) sensor

Gait analysis
Motion capture systemDEVICE

Gait analysis with reflective markers and pressure sensors

Gait analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject unable to give consent.
  • Subject unable to understand the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MIT Center for Clinical and Translational Research

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 31, 2024

Study Start

January 8, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)