Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

April 18, 2018

Primary Completion Date

October 1, 2024

Study Completion Date

November 18, 2024

Conditions
Lower Extremity Amputation
Interventions
DEVICE

Torsionally adaptive prosthesis with 0:1 coupling ratio

The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 0:1 means there will be no coupling between the transverse- and sagittal-plane motion. That is, regardless of any motion in the sagittal plane, there will be zero motion in the transverse plane.

DEVICE

Torsionally adaptive prosthesis with 1:6 coupling ratio

The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:6 means there will be one degree of motion in the transverse plane for every six degrees of motion in the sagittal plane.

DEVICE

Torsionally adaptive prosthesis with 1:4 coupling ratio

The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:4 means there will be one degree of motion in the transverse plane for every four degrees of motion in the sagittal plane.

DEVICE

Torsionally adaptive prosthesis with 1:3 coupling ratio

The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:3 means there will be one degree of motion in the transverse plane for every three degrees of motion in the sagittal plane.

DEVICE

Torsionally adaptive prosthesis with 1:2 coupling ratio

The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:2 means there will be one degree of motion in the transverse plane for every two degrees of motion in the sagittal plane.

Trial Locations (1)

98108-1532

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT03532100 - Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation | Biotech Hunter | Biotech Hunter