Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

Veterans Health Service Medical Center, Seoul, Korea

Status: Enrolling

Conditions: Amputation

Treatments: Device: RoFT® (Microprocessor ankle prosthesis); Device: Conventional ankle prosthesis; Device: Meridium® (Microprocessor ankle prosthesis)

Study type: Interventional

Funder types: Other

Identifiers

NCT04630457

2020-08-011

Details and patient eligibility

About

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.

Full description

In this study, the investigators will compare the safety and effectiveness of RoFT, a robotic ankle prosthesis developed by a Korea Institute of Machinery & Materials, Meridium of Ottobock Co., a representative commercial ankle-type robotic prosthesis, passive prosthetic limb that the patients have been using so far.

In order to compare the above three types of prostheses in terms of their effectiveness and safety, the robotic prosthesis will be evaluated after 30 minutes of familiarization after applying, and the evaluation interval using the two types of robotic prostheses will be 2 weeks to eliminate the carryover effect. For evaluation, 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 used.

For safety analysis, any kinds of safety issues including skin abrasion, bone fracture, or tendon/ligament injury due to fall down injury will be recorded and categorized for statistical analysis.

Enrollment: 42 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Among patients who visited each hospital's rehabilitation department after IRB approval
2. Adults over 19 years old
3. One side transtibial amputee
4. 6 months or more from the date of amputation of the lower extremities
5. Use of the same conventional passive prosthesis for at least the last 3 months
6. Factors of K level 2 or higher (have the ability to cross low-level environmental barriers such as curbs, stairs or uneven surfaces)
7. Those who understand and agree to the test description
8. Those who did not have skin lesions on the amputation at the time of study registration
9. At least 25cm of free space from the bottom connection of the socket to the floor

Exclusion criteria

1. When cognitive function is deteriorated and it is impossible to independently decide to participate in research or participate in evaluation
2. Contraindications to weight-bearing of the lower extremities such as severe lower extremity joint contracture, osteoporosis, and untreated fractures
3. Patients who underwent orthopedic surgery on the lower extremities within 6 months of starting the study
4. Cardiovascular disease, venous thrombosis or heart failure, respiratory disease that may affect heart function during exercise load
5. In the presence of pain in the musculoskeletal system other than amputation that affects gait
6. Stump length over 25cm
7. Subjects judged by other testers to be unsuitable for this study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Meridium-RoFT

Active Comparator group

Description:

order of existing prosthesis-Meridium prosthesis-RoFT prosthesis

Treatment:

Device: Meridium® (Microprocessor ankle prosthesis)

Device: Conventional ankle prosthesis

Device: RoFT® (Microprocessor ankle prosthesis)

RoFT-Meridium

Active Comparator group

Description:

order of existing prosthesis-RoFT prosthesis-Meridium prosthesis

Treatment:

Device: Meridium® (Microprocessor ankle prosthesis)

Device: Conventional ankle prosthesis

Device: RoFT® (Microprocessor ankle prosthesis)