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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831696
• Other study ID #: 5220320
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: Michael Davidson, Ph.D.
• Phone: 9095586516
• Email: mdavidson[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.

• a body mass greater than 49Kg and less than 117Kg

• 18-75 years of age

• Have an ambulation potential of K3 or K4

• Use a prosthesis daily for walking or sports activities

• No less than six months of experience with a prosthesis

• No socket issues or changes in the last six weeks

• No residual limb pain affecting functional ability.

Exclusion Criteria:

• Cannot walk at different speeds (MCFL K0-K2)

• Limb-loss below the knee or through the hip

• More than one amputation.

• Uses an assistive device for walking

• Uncontrolled edema in leg compartments

• Compromised skin of the residual limb or contralateral foot

• Are 180 days or less post-amputation

• Pregnant (self-reported)

Related Conditions & MeSH terms

• Transfemoral Amputation

Intervention

Other:
• Powered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Össur Ehf

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 uptake - level ground	VO2 uptake during ambulation on a treadmill - level ground	Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
Primary	VO2 uptake - incline	VO2 uptake during ambulation on a treadmill - 5 degree incline	Visit 2 (3 weeks post-study enrollment)
Secondary	Balance confidence	Activities based balance confidence survey (0-100%) higher score means more balance confidence	At Baseline Visit (study enrollment)
Secondary	Exertion	Borg Exertion Scale (0-10) with 10 being maximum exertion	Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)