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Comparison Between Three Types of Prosthetic Feet

NCT03046394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-05-04

No results posted yet for this study

Summary

One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.

Conditions

  • Amputation; Traumatic, Leg, Lower, Between Knee and Ankle

Interventions

DEVICE

C-SACH

Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1

DEVICE

B-DER

Dynamic Motion by Otto Bock, advertised for activity category 2-3

DEVICE

A-DER

Triton by Otto Bock, advertised for activity category 3-4

Sponsors & Collaborators

  • University Rehabilitation Institute, Republic of Slovenia

    lead OTHER

Principal Investigators

  • Helena Burger, MD, PhD · University Rehabilitation Institute, Republic of Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-02-10
Completion
2017-05-03

Countries

  • Slovenia

Study Locations

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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 NCT03046394 on ClinicalTrials.gov