The study aims to conduct a formative evaluation, along with verification, validation, and comparative analysis of the stumble recovery function in prosthetic devices by collecting relevant clinical data. The study will involve participants who are current users of lower-limb prosthetics. Utilizing a robust study design, data will be gathered in both controlled setting and real-world to thoroughly assess the performance, safety, and user satisfaction of the function. The scientific value of this research lies in its potential to enhance prosthetic technology, support evidence-based clinical practices, and ultimately improve the quality of life for users by reducing fall risks and increasing mobility confidence.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
User-Perceived Safety During Use of Stumble Recovery Function Assessed by 3-Point Scale
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Expert-Perceived Safety of Stumble Recovery Assessed by 3-Point Scale
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
User-Perceived Stability and Confidence
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Fall Rate Following Induced Perturbation Events Assessed by Direct Observation
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Stumble and Fall Detection Rate Assessed by Device Log Analysis
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Stumble and Fall Response Trigger Rate Assessed by Device Log Analysis
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Stumble and Fall False Detection Rate Assessed by Device Log Analysis
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Stumble Recovery False Trigger Rate Assessed by Device Log Analysis Stumble Recovery False Trigger Rate Stumble Recovery False Trigger Rate
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Fear of Falling Reduction Assessed by Falls Efficacy Scale-International (FES-I)
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Perceived Safety and Balance Assessed by Activities-specific Balance Confidence (ABC) Scale
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.
Stumble Recovery Ability Assessed by Motion Capture or Wearable Sensor Analysis
Timeframe: Assessed at the end of each device exposure period within formative (1 day use), verification (1 day use), validation (1 day use), and crossover phases (1-3 weeks use per exposure), at scheduled visits.