Evaluating Stumble Recovery Functions of Prosthetic Knees

Össur Iceland ehf

Status: Active, not recruiting

Conditions: Amputation of Lower Limb; Balance, Falls; Fall Prevention

Treatments: Device: Prosthetic Knee (e.g Power Knee, Navii, Rheo Knee, ...)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07266454

CIP2025012117

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Comprehensive Evaluation of Prosthetic Knee Devices

Experimental group

Description:

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.

Treatment:

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