Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

NCT04630457 | Unknown DMC

• 1 other identifier: 2020-08-011
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• 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. 1. Attach surface EMG to the above-mentioned muscles 2. Muscle activation start and end points within the walking cycle 3. Muscle activation period and RMS intergral and peak value 4. A value obtained by dividing the RMS (Root mean square) value into 16 sections by time 5. 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 1. Standing while sitting 2. Standing without help 3. Sit by yourself without leaning 4. Sitting while standing 5. Moving 6. Standing with your eyes closed 7. Standing with both feet together 8. Stretching and stretching arms in a standing position 9. Lifting objects off the floor while standing 10. Standing and looking back over both shoulders 11. Turning 360 degrees 12. Alternately placing both feet on the footrest while standing 13. Standing without support with one foot in front of the other 14. 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

Study Arms (2)

Meridium-RoFT

ACTIVE COMPARATOR

order of existing prosthesis-Meridium prosthesis-RoFT prosthesis

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

RoFT-Meridium

ACTIVE COMPARATOR

order of existing prosthesis-RoFT prosthesis-Meridium prosthesis

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

Interventions

Conventional ankle prosthesis DEVICE

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.

Meridium-RoFT; RoFT-Meridium

Meridium® (Microprocessor ankle prosthesis) DEVICE

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®.

Meridium-RoFT; RoFT-Meridium

RoFT® (Microprocessor ankle prosthesis) DEVICE

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®.

Meridium-RoFT; RoFT-Meridium

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Among patients who visited each hospital's rehabilitation department after IRB approval
• Adults over 19 years old
• One side transtibial amputee
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veterans Health Service Medical Center, Seoul, Korea: lead
• Asan Medical Center: collaborator
• Chungnam National University Hospital: collaborator

Study Sites (1)

Veterans Health Service Medical Center, Seoul, Korea

Seoul, 05368, South Korea

RECRUITING

Related Publications (12)

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  PMID: 1991946 RESULT

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  PMID: 12720619 RESULT

• 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.

  PMID: 28138492 RESULT

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  PMID: 18515291 RESULT

• 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.

  PMID: 12443950 RESULT

• 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.

  PMID: 16442547 RESULT

• 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.

  PMID: 9141121 RESULT

• 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.

  PMID: 4837552 RESULT

Study Officials

• Hee Seung Yang, MD

  Veterans Health Service Medical Center, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yup Kim, MD

CONTACT

+821030385432; futurer22c@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Researcher

Model Details: 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).

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: November 16, 2020
• Study Start: October 20, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)