Evaluating Stumble Recovery Functions of Prosthetic Knees

NCT ID: NCT07266454

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2030-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Comprehensive Evaluation of Prosthetic Knee Devices

Participants enrolled in this protocol will take part in one or more sequential study phases, including formative evaluation, verification, validation, and/or comparative crossover assessment. Depending on study design and eligibility, participants may contribute to different phases, such as providing feedback on iterative prototypes (formative phase), verifying device functions (verification phase), validating device effectiveness and safety in simulated real-world conditions (validation phase), or participating in randomized crossover comparisons of device performance with various configurations and/or comparator devices (comparative phase). Each participant will be exposed to the relevant device configurations and study conditions for the specific phase(s) in which they are enrolled.

Group Type: EXPERIMENTAL

Prosthetic Knee (e.g Power Knee, Navii, Rheo Knee, ...)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 40 kg < body weight < 136kg
• Cognitive ability to understand all instructions and questionnaires in the study
• Willing and able to participate in the study and following the protocol
• Age ≥ 18 years
• Able to walk independently without the use of assistive device such as a cane or walker
• Regular prosthesis users for at least 1 year with unilateral lower limb amputation at or below the transfemoral level (or equivalent level limb deficiency)

Exclusion Criteria

• Users with pain which can affect their mobility
• Users with socket comfort score less than 7
• Users with cognitive impairment
• Pregnant Users
• Musculoskeletal disorders or neurological conditions that affect motor function, gait or balance
• Use of medications that are known to impair balance and coordination
• Any other conditions deemed by the investigator to make participation unsafe

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iceland

OTHER

Sponsor Role: collaborator

Össur Iceland ehf

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thor Fridriksson, Doctor

Role: PRINCIPAL_INVESTIGATOR

Össur Iceland ehf

Locations

University of Iceland

Reykjavik, , Iceland

Össur Iceland ehf.

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

CIP2025012117

Identifier Type: -

Identifier Source: org_study_id