Device Range of Motion Verification

Introduction
Proper control of ankle range of motion (ROM) is necessary to ensure the device functions within safe mechanical limits and aligns with rehabilitation requirements.

Objectives
The objective of this verification activity is to confirm that the device mechanically restricts and allows motion within intended angular limits across all support settings.

Methods
The device was manually articulated through its full range of motion at each support level. Angular displacement was measured using a goniometer, and results were compared to expected mechanical limits defined in the design specifications.

Results
The device consistently operated within the intended angular limits. Increased support levels resulted in reduced range of motion, confirming that the mechanical constraints function as designed.

Device Range of Motion Validation

Introduction
Validation of range of motion ensures that the device performs effectively in a realistic use context and supports safe patient rehabilitation.

Objectives
The objective is to validate that the device allows functional ankle movement appropriate for different stages of recovery without causing discomfort or instability.

Methods
Simulated use testing was conducted by having users wear the device and perform controlled ankle movements. Feedback was collected regarding comfort, perceived restriction, and stability during motion.

Results
Users reported that the device allowed natural and controlled movement while providing appropriate restriction. The ROM settings aligned well with expected rehabilitation needs, supporting effective and safe use.