CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Investigational prosthetic footdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03703232
NCT03703232N/ACompleted

An Adaptable Foot Prosthesis for People With Lower Extremity Amputations - Community Experiences

University of Washington·interventional·Posted Oct 11, 2018·Updated Jun 21, 2024

In Brief

A clinical study evaluating Investigational prosthetic foot for Lower Extremity Amputation. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. To accomplish this, the study will use a combination of laboratory motion analysis, functional tests, and community mobility trials where participants complete questionnaires and interviews about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. Individuals with amputations that participate in the (optional) motion analysis sub-study at the University of Washington will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The participants will rate their experiences using socket comfort score and the socket pressure score. Control participants recruited at the University of Washington to provide information about performance for people without amputation will go through the consenting process, then will be asked to complete forward walking, Figure-of-8 Walk Test, Narrowing Beam Walking Test, side-step, and walking across river rock surface. These tests will be conducted at a single session.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartMar 15, 2016
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.7 years ago

Interventions

Investigational prosthetic footdevice

Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.