Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

NAUnknownINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 20, 2020

Primary Completion Date

June 30, 2024

Study Completion Date

December 31, 2024

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®.

Trial Locations (1)

05368

RECRUITING

Veterans Health Service Medical Center, Seoul, Korea, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Asan Medical Center

OTHER

collaborator

Chungnam National University Hospital

OTHER

lead

Veterans Health Service Medical Center, Seoul, Korea

OTHER

NCT04630457 - Safety and Effectiveness of Electronically Controlled Prosthetic Ankle | Biotech Hunter | Biotech Hunter