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Evaluating Stumble Recovery Functions of Prosthetic Knees

NCT07266454 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Iceland

    collaborator OTHER

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • Thor Fridriksson, Doctor · Össur Iceland ehf

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2030-05-31
Completion
2030-05-31

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266454 on ClinicalTrials.gov