Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Effectiveness of Electronically Controlled Prosthetic Ankle in Patients With Transtibial Amputation

Conditions
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Amputation

Intervention / Treatment
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* Device: Conventional ankle prosthesis
* Device: Meridium® (Microprocessor ankle prosthesis)
* Device: RoFT® (Microprocessor ankle prosthesis)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Among patients who visited each hospital's rehabilitation department after IRB approval Adults over 19 years old One side transtibial amputee 6 months or more from the date of amputation of the lower extremities Use of the same conventional passive prosthesis for at least the last 3 months Factors of K level 2 or higher (have the ability to cross low-level environmental barriers such as curbs, stairs or uneven surfaces) Those who understand and agree to the test description Those who did not have skin lesions on the amputation at the time of study registration At least 25cm of free space from the bottom connection of the socket to the floor Exclusion Criteria: When cognitive function is deteriorated and it is impossible to independently decide to participate in research or participate in evaluation Contraindications to weight-bearing of the lower extremities such as severe lower extremity joint contracture, osteoporosis, and untreated fractures Patients who underwent orthopedic surgery on the lower extremities within 6 months of starting the study Cardiovascular disease, venous thrombosis or heart failure, respiratory disease that may affect heart function during exercise load In the presence of pain in the musculoskeletal system other than amputation that affects gait Stump length over 25cm Subjects judged by other testers to be unsuitable for this study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is a Prospective Randomized crossover study. After randomization, the study is conducted by dividing group A (order of existing prosthesis-Meridium prosthesis-RoFT prosthesis) and B (order of existing prosthesis-RoFT prosthesis-Meridium prosthesis).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meridium-RoFT<br>order of existing prosthesis-Meridium prosthesis-RoFT prosthesis | Device: Conventional ankle prosthesis<br>* 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.<br>Device: Meridium® (Microprocessor ankle prosthesis)<br>* 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®.<br>Device: RoFT® (Microprocessor ankle prosthesis)<br>* 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®.<br>|
| Active Comparator: RoFT-Meridium<br>order of existing prosthesis-RoFT prosthesis-Meridium prosthesis | Device: Conventional ankle prosthesis<br>* 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.<br>Device: Meridium® (Microprocessor ankle prosthesis)<br>* 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®.<br>Device: RoFT® (Microprocessor ankle prosthesis)<br>* 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®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Changes in Three-dimensional motion during walking | Three-dimensional motion analysis Using 8 infrared cameras and 3 force plates, set the spatial coordinates of each camera To do this, a non-linear trasformation (NLT) method is used. Attach 19 reflective markers for static measurement and 15 reflective markers for dynamic measurement in the standstill state on the joints and segment surfaces of the lower extremities. Static, Dynamic common Bilateral: ■ Anterior superior iliac spine ■ On the anterior thigh ■ Lateral epicondyle of femur ■ on the lower leg ■ Lateral malleolus aligned with bimalleolar axis ■ Bisection of the proximal aspect of the posterior calcaneum ■ Dorsal surface of the left (and right) distal forefoot at the midpoint-the 2nd metatarsal head Unilateral: ■ Sacrum: Mid-point on line between the PSISs Static only -Bilateral: ■ Medial epicondyle of femur ■ Medial malleolus aligned with bimalleolar axis | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis | 
| Analysis of Changes in dynamic EMG during walking | Dynamic EMG is calculated by measuring EMG signals by attaching surface EMG to the skin using a tape on Vastus Medialis, Rectus Femoris, Tensor Fascia Latae, Medial Hamstring, and Gluteus Maximus of both lower extremities, measuring the EMG signal, and converting it to Root mean square (RMS). The measured EMG signal is used to calculate the activation period and timing according to the gait cycle for each muscle, and analyze the degree of activation. Attach surface EMG to the above-mentioned muscles Muscle activation start and end points within the walking cycle Muscle activation period and RMS intergral and peak value A value obtained by dividing the RMS (Root mean square) value into 16 sections by time Comparison between healthy side and affected side | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis | 
| Analysis of Changes in Energy consumption during walking | Using QUARK CPET (COSMED, Italy) Perform calibration of the gas respiration analyzer 30 minutes before the start of the experiment and maintain the temperature and humidity inside the laboratory. Before measurement, each amputated patient sits on a chair on the treadmill, rests for 5 minutes, and then walks on the treadmill at a comfortable pace for 3 minutes. Afterwards, all amputated patients are asked to walk on the treadmill at a self-selected walking velocity. The preferred speed is set to a level in which conversation is possible by deep breathing through a rating of perceived exertion (RPE). Measurement is made at a preferred speed and 12% slope for 10 minutes, and walk for at least 6 minutes. If it is difficult to measure at a slope of 12% due to the subject's physiological characteristics, measure at a slope of 0%. The value of rate(ml/min/kg) is obtained by averaging the value during the steady state for the last minute of the measurement section. | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis | 
| Analysis of Changes in 6 minute walk test | A sub-maximal exercise test used to evaluate a patient's aerobic capacity and endurance. Measure the endurance of walking by marking the distance at 30m intervals and measuring the number of round trips for 6 minutes. | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis | 
| Analysis of Changes in Berg balance scale(BBS) scores | A balanced evaluation tool consisting of 14 items and a perfect score of 56 Item Standing while sitting Standing without help Sit by yourself without leaning Sitting while standing Moving Standing with your eyes closed Standing with both feet together Stretching and stretching arms in a standing position Lifting objects off the floor while standing Standing and looking back over both shoulders Turning 360 degrees Alternately placing both feet on the footrest while standing Standing without support with one foot in front of the other Standing on one leg | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis | 
| Analysis of Changes in Locomotor Capabilities Index (LCI) scores | A scale consisting of 14 items and 56 points for the ability of patients with lower body amputation to perform activities with their will Item ◆ Basic activity score 1. Get up from the chair 2. Walking in the house 3. Walking on a flat surface outdoors 4. Climbing stairs by holding a railing 5. Go down the stairs by holding the railing 6. Climb on the sidewalk block 7. Going down the sidewalk block ◆ Advanced activity score 1. Lifting objects off the floor (while standing with prosthetic feet) 2. Get up from the floor (eg, if you fall) 3. Walking outdoors on uneven ground (eg meadows, gravel, slopes) 4. Walking outdoors in inclement weather (eg snow, rain, ice) 5. Climb a few steps up the stairs without holding the railing 6. Walking down the stairs a few steps without holding the railing 7. Walking with objects | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis | 
| Analysis of Changes in Korean-Prosthesis Evaluation Questionnaire (K-PEQ) scores | PEQ is the quality of life in various areas such as function, overall satisfaction, pain, psychosocial experience, gait and mobility, satisfaction in special situations, ability to perform daily life, will function and quality in relation to the use of the will of the amputationally disabled person. Develop to evaluate PEQ is an evaluation tool conducted after 4 weeks of prosthesis and consists of a total of 86 questions in 8 areas. PEQ has proven high reliability, internal consistency, content validity, and criterion validity, so it is mainly used in studies related to the will of amputation disorders. | (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis |