Digital Biomarker Using Smartphone Sensors for SMA Assessment
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Solution Overview
Problem
Current methods for assessing symptom severity and progression of muscular disabilities, particularly spinal muscular atrophy (SMA), require frequent in-clinic monitoring, which is costly and inconvenient, necessitating a more efficient and cost-effective remote assessment solution.
Innovation Solution
A diagnostic device comprising a processor, sensors, and memory that receives sensor data to assess axial motor function, enabling remote monitoring and analysis of symptoms through smartphone applications, utilizing motion, gyroscope, and pressure sensors to determine symptom severity and progression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If in-clinic monitoring and testing is performed frequently, then measurement precision and reliability of symptom assessment is improved, but cost and inconvenience to the subject increases
Solution Approach 1:
The patent replaces the mechanical/in-person clinical assessment system with a digital smartphone-based system. The smartphone application performs automated sensor-based measurements (accelerometer, gyroscope, barometer) to assess axial motor function, eliminating the need for frequent in-clinic visits while maintaining assessment reliability through objective digital data collection.
Solution Approach 2:
The system enables self-service monitoring where the subject independently performs assessment tasks using their own smartphone device. The application guides the subject through standardized motor function tests, automatically collects data via sensors, and provides assessments without requiring clinical staff presence, thereby improving convenience while maintaining measurement quality.
2Measurement precision
If in-clinic monitoring and testing frequency is increased, then detection precision of symptom progression is improved, but cost to the health system increases
Solution Approach 1:
The patent creates a digital copy of the clinical assessment process through a smartphone application that replicates standardized motor function tests. The application uses sensor data (accelerometer, gyroscope, barometer) to capture and store assessment information, providing a cost-effective digital alternative to repeated in-clinic visits that maintains measurement precision while reducing health system costs.
Solution Approach 2:
The smartphone application serves as an intermediary between the subject and the health system. It automatically collects, stores, and transmits assessment data, enabling remote monitoring that reduces the need for expensive in-clinic visits while maintaining the ability to detect symptom progression through standardized digital measurements.
3Reliability
If standardized clinical tests are used, then reliability of diagnosis is improved, but ease of operation and subject convenience deteriorates
Solution Approach 1:
The patent makes the assessment system universal by implementing standardized motor function tests within a universal smartphone application that can be used by any subject with a smartphone. The application integrates multiple sensor types (accelerometer, gyroscope, barometer) and standardized test protocols, making reliable clinical assessment accessible and convenient for all subjects without requiring specialized equipment or clinical settings.
Data Source
AI summary
Currently, assessing the severity and progression of symptoms in a subject diagnosed with a muscular disability, in particular SMA involves in-clinic monitoring and testing of the subject every 6 to 12 months. However, monitoring and testing a subject more frequently is preferred, but increasing the frequency of in-clinic monitoring and testing can be costly and inconvenient to the subject. Thus, assessing the severity and progression of symptoms via remote monitoring and testing of the subject outside of a clinic environment as described herein provides advantages in cost, ease of monitoring and convenience to the subject. Systems, methods and devices according to the present disclosure provide a diagnostic for assessing of the axial motor function of a subject having a muscular disability, in particular SMA by active testing of the subject.