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

Transfemoral Amputation Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Transfemoral Amputation

• NCT number: NCT05831696
• Study type: Interventional
• Source: Loma Linda University
• Contact: Michael Davidson, Ph.D.
• Phone: 9095586516
• Email: mdavidson@llu.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Completion date: February 2025