Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation
• Intervention / Treatment: Device: Conventional ankle prosthesis; Device: Meridium® (Microprocessor ankle prosthesis); Device: RoFT® (Microprocessor ankle prosthesis)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Yup Kim, MD; Phone Number: +821030385432; Email: futurer22c@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05368
    • Recruiting
    • Veterans Health Service Medical Center, Seoul, Korea
    • Contact: Hee Seung Yang, MD; Phone Number: +821075041619; Email: yang7310@naver.com
    • Contact: Pyung Hwa Choi, PhD; Phone Number: +1027288422; Email: peace8422@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Meridium-RoFT; order of existing prosthesis-Meridium prosthesis-RoFT prosthesis	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®.
ACTIVE_COMPARATOR: RoFT-Meridium; order of existing prosthesis-RoFT prosthesis-Meridium prosthesis	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®.

What is the study measuring?

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; ItemStanding while sittingStanding without helpSit by yourself without leaningSitting while standingMovingStanding with your eyes closedStanding with both feet togetherStretching and stretching arms in a standing positionLifting objects off the floor while standingStanding and looking back over both shouldersTurning 360 degreesAlternately placing both feet on the footrest while standingStanding without support with one foot in front of the otherStanding 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

Collaborators and Investigators

• Sponsor: Veterans Health Service Medical Center, Seoul, Korea
• Collaborators: Asan Medical Center; Chungnam National University Hospital
• Investigators: Principal Investigator: Hee Seung Yang, MD, Veterans Health Service Medical Center, Seoul, Korea

Publications and helpful links

General Publications

• Han TR, Paik NJ, Im MS. Quantification of the path of center of pressure (COP) using an F-scan in-shoe transducer. Gait Posture. 1999 Dec;10(3):248-54. doi: 10.1016/s0966-6362(99)00040-5.
• Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Evaluation of gait symmetry after stroke: a comparison of current methods and recommendations for standardization. Gait Posture. 2010 Feb;31(2):241-6. doi: 10.1016/j.gaitpost.2009.10.014. Epub 2009 Nov 22.
• Collen FM, Wade DT, Bradshaw CM. Mobility after stroke: reliability of measures of impairment and disability. Int Disabil Stud. 1990 Jan-Mar;12(1):6-9. doi: 10.3109/03790799009166594.
• Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
• Bischoff HA, Stahelin HB, Monsch AU, Iversen MD, Weyh A, von Dechend M, Akos R, Conzelmann M, Dick W, Theiler R. Identifying a cut-off point for normal mobility: a comparison of the timed 'up and go' test in community-dwelling and institutionalised elderly women. Age Ageing. 2003 May;32(3):315-20. doi: 10.1093/ageing/32.3.315.
• Hofheinz M, Mibs M. The Prognostic Validity of the Timed Up and Go Test With a Dual Task for Predicting the Risk of Falls in the Elderly. Gerontol Geriatr Med. 2016 Mar 16;2:2333721416637798. doi: 10.1177/2333721416637798. eCollection 2016 Jan-Dec.
• Nordin E, Lindelof N, Rosendahl E, Jensen J, Lundin-Olsson L. Prognostic validity of the Timed Up-and-Go test, a modified Get-Up-and-Go test, staff's global judgement and fall history in evaluating fall risk in residential care facilities. Age Ageing. 2008 Jul;37(4):442-8. doi: 10.1093/ageing/afn101. Epub 2008 May 30.
• Schmalz T, Blumentritt S, Jarasch R. Energy expenditure and biomechanical characteristics of lower limb amputee gait: the influence of prosthetic alignment and different prosthetic components. Gait Posture. 2002 Dec;16(3):255-63. doi: 10.1016/s0966-6362(02)00008-5.
• Schache AG, Baker R, Vaughan CL. Differences in lower limb transverse plane joint moments during gait when expressed in two alternative reference frames. J Biomech. 2007;40(1):9-19. doi: 10.1016/j.jbiomech.2005.12.003. Epub 2006 Jan 26.
• Gailey RS, Nash MS, Atchley TA, Zilmer RM, Moline-Little GR, Morris-Cresswell N, Siebert LI. The effects of prosthesis mass on metabolic cost of ambulation in non-vascular trans-tibial amputees. Prosthet Orthot Int. 1997 Apr;21(1):9-16. doi: 10.3109/03093649709164525.
• Winter DA, Sidwall HG, Hobson DA. Measurement and reduction of noise in kinematics of locomotion. J Biomech. 1974 Mar;7(2):157-9. doi: 10.1016/0021-9290(74)90056-6. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2020
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (ACTUAL): November 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-08-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing is planned for protection of privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No