Best 6-Minute Effort (B6ME)

The next-generation six-minute walk test (6MWT)

Get Advanced Measures of Physical Function

With Wearable Sensor Technologies and Analytics

Get Advanced Measures of Physical Function

The Best 6-Minute Effort (B6ME)™ is a novel outcome assessment that helps researchers achieve a comprehensive picture of how disease impacts patient functioning in their real-word environment. It parallels the accepted 6MWT, using wearable sensors to track the peak 6-minute effort within a calendar day. Real-world movement and mobility-related information collected over weeks, months, or years, significantly advance our understanding of disease expression and therapeutic outcomes.

Derive Continuous Real-World Endpoints

for Clinical Trials and Healthcare

Derive Continuous Real-World Endpoints

B6ME is a sustained assessment of disease activity, providing insight into how patients function during their everyday activities. Data are collected within an FDA regulated framework using medical-grade, wrist-worn, or other fit-for-purpose wearable devices.

Using a wearable sensor, we can derive more detailed measures of movement and mobility beyond what is possible from in-clinic standardized assessments. By identifying a best six-minute effort, additional digital measures of heart rate, respiration rate, steps, cadence, stride length, and stride velocity may be provided in this defined context.

Challenges of Traditional Measures

To measure the impact of new drugs on physical activity, scientists have traditionally relied on the 6-Minute Walk Test (6MWT), a measure of physical function performed in standardized clinic settings. It's worked well for years, but the relevance of in-clinic performance tests to a patient's real-world activity is limited. Three of the biggest challenges to the 6MWT approach are:

1. Lack of Relevancy

Data collected in a clinical setting may not necessarily be related to the patient's regular daily activity. In-clinic performance tests may not fully capture an aspect of health that is meaningful to the patient.

2. Infrequent Clinic Visits

Reliability and responsiveness are questionable when assessed at infrequent study time points. For all diseases, symptom expression is unpredictable and complex. The infrequent nature of in-person clinic assessments misses important information.

3. Subject to Subjectivity

Performance tests used in study endpoints are subject to clinician and patient bias and motivation. The 6MWT may be influenced by the researcher conducting the test or the patient's motivation to perform well.

B6ME™ Provides Additional Granularity

The 6MWT is a single snapshot approach. It is augmented with B6ME™, which uses innovative wearable sensor technology to provide the additional granularity of patient functioning and novel movement and mobility-related endpoints.

B6ME™

Best 6-Minute Effort

Timing
Daily (Continous)

Environment
Real-World

Endpoint Formulation
Change from Baseline
Daily Variation

Endpoints
Distance Walked
Number of Steps
Cadence
Duration of Walking
Timing of Event
Gait Parameters

6MWT

6-Minute Walk Test

Timing
Pre/Post Intervention (Snapshot)

Environment
In Clinic

Endpoint Formulation
Change from Baseline
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Endpoints
Distance Walked
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Expand Your Capabilities

Develop Digital Biomarkers for Clinical Trials

Our approach to wearable sensor digital endpoints includes study design, sensor selection, scientific consulting, validation, data quality control, and machine learning with customized data analysis - all in an FDA approved compliant platform. Fill out the form to contact us today.

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