Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

Not Applicable

Recruiting

• Conditions: Amputation; Traumatic, Leg, Lower; Limb; Absence, Congenital, Lower; Prosthesis User; Lower Limb Amputation Above Knee (Injury); Traumatic, Leg: Thigh, Between Hip and Knee

• Registration Number: NCT06194838
• Lead Sponsor: Liberating Technologies, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Inclusion Criteria:<br><br> - Are at least 18 years old<br><br> - Transfemoral prosthesis user (limb absence between the knee and hip)<br><br> - Current user of a mechanical knee<br><br> - Regularly wears prosthesis at least 5 days per week<br><br> - Have adequate clearance between distal end and ground for necessary knee and foot<br> components<br><br> - Current Medicare Functional Classification Level (K-Level) of 2 as determined by the<br> healthcare team<br><br> - Socket-Comfort Score: 6 or above to ensure adequate socket fit<br><br> - Six months or more experience on a prosthesis<br><br> - Body weight between 50kg and 116kg (110lbs - 256lbs)<br><br> - Height between 1.2m and 1.95m (47.2in and 76.8in)<br><br> - Has a phone to answer periodic study calls<br><br>Exclusion Criteria:<br><br> - Present injuries to residual limb or contralateral leg affecting functional ability<br><br> - Contralateral amputation proximal to MTP (metatarsophalangeal) joint<br><br> - Socket issues/changes in the last 6 weeks<br><br> - Users with bone-anchored implants<br><br> - Health or medical condition, diagnosis, or other cause that would prevent<br> participant from effectively following study protocol, performing required outcome<br> measures, and/or completing the study<br><br>Subjects can be excluded at the discretion of the investigator for other unforeseen<br>disqualifying criteria (such as specific cognitive issues, etc.).<br><br>If subjects experience a health or medical condition that leaves them immobile for more<br>than 2 weeks, they may be given the option to restart the study condition upon recovery,<br>as long as eligibility criteria is still met, and comparable baseline functionality is<br>demonstrated with outcomes measures.<br><br>Using a knee that the subject is unfamiliar with may increase the risk of falling.<br>Therefore, pregnant women should not participate in the study and will be screened by<br>self-disclosure.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Step count;Activities-Specific Balance Confidence scale (ABC) - Measuring change from baseline;Prosthesis Evaluation Questionnaire - Well Being (PEQ-WB) - Measuring change from baseline