Muscle Strength Evaluation Using Time to Zero Force Velocity

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Solution Overview

Problem

Current methods for tracking disease progression in conditions like ALS are insensitive, requiring long follow-up times, large sample sizes, and are not effective in detecting changes in a short time period.

Innovation Solution

A novel method that measures muscle function and determines the time to zero strength (TZFV) for a preselected combination of muscles, providing a more sensitive and accurate method for evaluating and tracking diseases associated with loss of muscle function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional endpoints (survival and ALSFRS) are used to track disease progression, then the evaluation is validated and clinically recognized, but the follow-up time is very long (12-18 months) and the sensitivity to detect disease progression is low

Engineering Contradiction:
Improvevalidation of endpointVSAvoidfollow-up time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent changes the measurement parameter from subjective functional ratings (ALSFRS) and survival outcomes to objective muscle strength measurements using dynamometry. This parameter change enables detection of disease progression at an earlier stage, reducing follow-up time while maintaining clinical relevance through direct measurement of muscle function loss.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If traditional endpoints (survival and ALSFRS) are used, then the evaluation is clinically recognized, but the sample size required is very large (300-400 participants per arm)

Engineering Contradiction:
Improveclinical recognitionVSAvoidsample size
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent replaces the complex multi-parameter clinical assessment system (ALSFRS, survival tracking) with a simpler direct muscle strength measurement system. This substitution increases measurement sensitivity, allowing smaller sample sizes to achieve the same statistical power while maintaining clinical recognition through objective physiological data.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If traditional endpoints are used, then the evaluation method is simple and validated, but the sensitivity to track disease progression within a short time follow-up is low

Engineering Contradiction:
Improveevaluation simplicityVSAvoidsensitivity to disease progression
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent extracts the core function of disease progression tracking from the complex ALSFRS questionnaire and survival metrics, isolating it to direct muscle strength measurement. This extraction maintains operational simplicity through standardized dynamometry protocols while dramatically improving sensitivity by directly measuring the physiological mechanism of disease progression.

Inventive Principle:
Principle #2Taking out (Extraction)

4Measurement precision

If aggregated muscle strength values (megascore) are used to track disease progression, then the measurement is objective, but no study has shown superiority over ALSFRS-R and they are rarely used as primary endpoints

Engineering Contradiction:
Improveobjectivity of measurementVSAvoidclinical utility
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent segments the muscle strength measurement into specific, individually measured muscle groups rather than using aggregated scores. This segmentation allows detection of progression in specific muscle regions, providing more precise and clinically actionable data that directly addresses the limitations of both ALSFRS-R and megascore approaches.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS20250032042A1Methods for evaluating patients
Publication Date: 2025.01.30 BIOGEN MA INC
  • US20250032042A1 patent drawing
  • US20250032042A1 patent drawing
  • US20250032042A1 patent drawing

AI summary

Methods for evaluating subjects having conditions associated with loss of muscle function (e.g., a motor neuron disease, a neuromuscular disease, or a myopathy) by measuring muscle function (e.g., muscle strength) are disclosed.