Clinical Trials Logo

Clinical Trial Summary

Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment at baseline utilizing their current passive prosthesis. Subjects will then be randomly assigned into 2 equal groups: Powered device with an 8-session intensive, device-specific PT intervention (Group A); or powered device with current standard of practice (Group B), with includes basic device education, but no PT intervention. Subjects in Group A will undergo a 4-week PT-based intervention, which will isolate the contribution of device specific effects from rehabilitation effects. Group B will receive the current standard of practice, which does not include any formal rehabilitation. All users will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment after 4- and 8-weeks of use.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03625921
Study type Interventional
Source VA New York Harbor Healthcare System
Contact Michael Hyre, MS
Phone 212-951-3339
Email michael.hyre@va.gov
Status Recruiting
Phase N/A
Start date November 17, 2017
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Not yet recruiting NCT05548322 - Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses N/A
Completed NCT02316262 - Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in Major Limb Amputation N/A
Recruiting NCT05870267 - Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
Completed NCT03530956 - Evaluation of a Novel Bionic Foot, AMPfoot 4+ N/A
Completed NCT03498872 - Strategic Research Program 17 (VUB Funding) N/A
Completed NCT04730492 - HErnias REparation After Kidney Transplantation Study
Completed NCT05190354 - Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System N/A
Completed NCT04272593 - Pattern Recognition Prosthetic Control N/A
Completed NCT05112679 - Limb Health and Socket Pressure in Response to Powered Ankle Protheses N/A
Completed NCT04595071 - Functional Outcomes of Voice Recognition Prosthesis N/A
Completed NCT03329326 - Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome
Terminated NCT03575975 - 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Completed NCT05048355 - Metabolic Cost of Walking With Passive vs. Powered Microprocessor Controlled Knees N/A
Completed NCT05124873 - Moisture Management Liner At-Home Evaluation N/A
Recruiting NCT05267639 - Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees N/A
Completed NCT05749952 - Digital Weight Bearing Shape Capture Socket Technology N/A
Not yet recruiting NCT06052501 - 3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations
Active, not recruiting NCT04536025 - Shared Decision Making Aid for Prosthetic Design