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Development and Validation of an Algorithm to Objectively Quantify Adherence to Offloading Interventions.

Sai V Yalla1,2, Sanam N Jhaveri1, Nahir S Negron-Fernandez1

  • 1Center for Lower Extremity Ambulatory Research (CLEAR), Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, USA.

Journal of Foot and Ankle Research
|June 3, 2026
PubMed
Summary
This summary is machine-generated.

A new method accurately tracks adherence to diabetic foot ulcer offloading devices like the removable cast walker (RCW) and shoe-lift. This technology improves monitoring of real-world patient behavior for better healing outcomes.

Keywords:
accelerometercast walkerdiabetesfoot ulcerstanding timestep count

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Area of Science:

  • Biomedical Engineering
  • Orthopedics
  • Wearable Technology

Background:

  • Diabetic foot ulcers (DFUs) necessitate offloading for effective healing.
  • Poor adherence to removable offloading devices is a significant clinical challenge.
  • Previous adherence measurement methods had limitations, hindering accurate behavioral insights.

Purpose of the Study:

  • To develop and validate a novel method for objectively tracking adherence to offloading devices during ambulation and static weight-bearing.
  • To assess adherence to both a removable cast walker (RCW) and a contralateral shoe-lift simultaneously.

Main Methods:

  • Thirty healthy adults were monitored using accelerometers on RCWs, shoe-lifts, and thighs.
  • A custom algorithm was developed to classify adherence based on variance thresholds during walking and standing.
  • Adherence data was compared against investigator logs and participant diaries over 24 hours.

Main Results:

  • The algorithm demonstrated over 99% accuracy in detecting steps and standing in laboratory settings.
  • Excellent agreement (ICC > 0.96) was observed between algorithm-derived adherence and diary entries in community monitoring.
  • Misclassification error rates were below 3%.

Conclusions:

  • A validated method for objectively quantifying adherence to RCWs and shoe-lifts has been established.
  • The findings support the use of this method for monitoring real-world offloading behavior in clinical trials.
  • This technology has the potential to enhance adherence assessments and be integrated into clinical practice for patient monitoring.