MedTrace Logo

Limb Health and Socket Pressure in Response to Powered Ankle Protheses

NCT05112679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-11-25

Study results available
· View outcomes & findings →

Summary

this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.

Conditions

  • Pressure Ulcer, Ankle
  • Prosthesis User
  • Prosthesis Durability
  • Mobility Limitation
  • Skin Wound
  • Amputation; Traumatic, Foot
  • Amputation
  • Limb Deficiencies

Interventions

DEVICE

PROPRIO FOOT® by Ossur & Empower ankle by Ottobock

PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.

Sponsors & Collaborators

  • University of Notre Dame

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Indiana University

    lead OTHER

Principal Investigators

  • Sashwati Roy, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-07-19
Completion
2023-07-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05112679 on ClinicalTrials.gov