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Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

NCT04630457 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-11-16

No results posted yet for this study

Summary

In this study, we aim to compare the three types of prosthetic limbs: the passive prosthetic limb that the patients have been using so far, the 'RoFT', a prosthetic limb developed by the Korea Institute of Machinery \& Materials, and the Meridium of Ottobock in terms of safety and effectiveness.

Conditions

  • Amputation

Interventions

DEVICE

Conventional ankle prosthesis

At the first visit, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be evaluated using the conventional prosthesis that the patient had.

DEVICE

Meridium® (Microprocessor ankle prosthesis)

There are two weeks apart between each visit. Depending on the group to which the patient belongs, at the second or third visit, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be evaluated using Meridium®. For example, if visit 2 was evaluated using Meridium®, visit 3 was evaluated using RoFT®. In another example, visit 2 is evaluated using RoFT®, while Visit 3 is evaluated using Meridium®.

DEVICE

RoFT® (Microprocessor ankle prosthesis)

There are two weeks apart between each visit. Depending on the group to which the patient belongs, at the second or third visit, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be evaluated using RoFT®. For example, if visit 2 was evaluated using RoFT®, visit 3 was evaluated using Meridium®. In another example, visit 2 is evaluated using Meridium®, while Visit 3 is evaluated using RoFT®.

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Chungnam National University Hospital

    collaborator OTHER

  • Veterans Health Service Medical Center, Seoul, Korea

    lead OTHER

Principal Investigators

  • Hee Seung Yang, MD · Veterans Health Service Medical Center, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • South Korea

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 NCT04630457 on ClinicalTrials.gov