NCT07266454

Evaluating Stumble Recovery Functions of Prosthetic Knees

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fall Prevention
• Balance, Falls
• Amputation of Lower Limb

Interventions

Type	Name	Description
DEVICE	Prosthetic Knee (e.g Power Knee, Navii, Rheo Knee, ...)	Participants will use one or more investigational prosthetic knee devices, which may include \[list trade names, e.g., Navii, Rheo Knee, Power Knee\], under different conditions as part of one or more study phases, including formative evaluation, verification, validation, and/or comparative crossover assessment. The study may include multiple device configurations or models within the prosthetic knee class, and comparative assessment against standard of care or alternative prosthetic knee devices as applicable.

Timeline

• Start date: 2025-12-01
• Primary completion: 2030-05-31
• Completion: 2030-05-31
• First posted: 2025-12-05
• Last updated: 2026-01-16

Locations

2 sites across 1 country: Iceland