NCT05831696

Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.

Detailed description

The Procedures include: Initial Visit: 1. Informed consent 2. HIPAA authorization 3. Determine/verify ambulation potential 4. Take and record body measurements (height, weight, circumferences) 5. Activities-Specific Balance Confidence (ABC) scale 6. L.A.S.A.R. Posture alignment assessment with RxPx Second Visit 1. Fit with heartrate monitor and metabolic analyzer mask 2. Treadmill Test (level-ground) with RxPx 3. Rest 4. Treadmill Test (incline) with RxPx 5. Fit subject with PMPK 6. L.A.S.A.R. Posture alignment assessment with PMPK 7. Subject uses PMPK for one week as their primary prosthesis Third Visit (1 week later) 1. Fit with heartrate monitor and metabolic analyzer mask 2. Treadmill Test (level-ground) with PMPK 3. Rest 4. Treadmill Test (incline) with PMPK 5. Activities-Specific Balance Confidence (ABC) scale 6. Return PMPK and refit of RxPx 7. Verify alignment with L.A.S.A.R. Posture alignment 8. Check that all fasteners are secure

Conditions

• Transfemoral Amputation

Interventions

Type	Name	Description
OTHER	Powered Microprocessor-controlled Knee (PMPK)	A microprocessor-controlled Knee with standardized commercial prosthetic foot

Timeline

• Start date: 2023-02-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-04-26
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States