AmputationNCT04630457
Safety and Effectiveness of Electronically Controlled Prosthetic Ankle
A study testing Conventional ankle prosthesis, Meridium® (Microprocessor ankle prosthesis) and RoFT® (Microprocessor ankle prosthesis) in people with Amputation, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Conventional ankle prosthesis, Meridium® (Microprocessor ankle prosthesis) and RoFT® (Microprocessor ankle prosthesis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Veterans Health Service Medical Center, Seoul, Korea
Seoul, 05368
Hee Seung Yang, MD, +821075041619, yang7310@naver.com
Pyung Hwa Choi, PhD, +1027288422, peace8422@naver.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Conventional ankle prosthesis, Meridium® (Microprocessor ankle prosthesis), RoFT® (Microprocessor ankle prosthesis)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ankle prosthesisDevice
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® (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®.
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®.
| Study group | Role | What they receive |
|---|---|---|
| Meridium-RoFT | Active comparator | order of existing prosthesis-Meridium prosthesis-RoFT prosthesis Receives: 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 Receives: Device: Conventional ankle prosthesis; Device: Meridium® (Microprocessor ankle prosthesis); Device: RoFT® (Microprocessor ankle prosthesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: (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
Measured: (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.
Measured: (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.
Measured: (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
Measured: (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
Measured: (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.
Measured: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start20 Oct 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Chungnam National University Hospital
- Responsible party
- Principal investigator, Jun Yup Kim, MD, Veterans Health Service Medical Center, Seoul, Korea
- Investigators
- Hee Seung Yang, MD, Principal investigator, Veterans Health Service Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630457
- Sponsor's protocol ID
- 2020-08-011
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing is planned for protection of privacy.
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.
PubMed 10567757Patterson 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.
PubMed 19932621Collen 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.
PubMed 2211468Flansbjer 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.
PubMed 15788341Podsiadlo 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.
PubMed 1991946Bischoff 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.
PubMed 12720619Hofheinz 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.
PubMed 28138492Nordin 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.
PubMed 18515291Schmalz 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.
PubMed 12443950Schache 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.
PubMed 16442547Gailey 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.
PubMed 9141121Winter 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.
PubMed 4837552
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Electronically Controlled Prosthetic Ankle in Patients With Transtibial Amputation
- ClinicalTrials.gov ID
- NCT04630457
- Acronym / sponsor ID
- 2020-08-011
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, KoreaUniversity, hospital or other
- Collaborators
- Asan Medical Center, Chungnam National University Hospital
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Meridium-RoFT | Active comparator | Device: Conventional ankle prosthesis, Device: Meridium® (Microprocessor ankle prosthesis), Device: RoFT® (Microprocessor ankle prosthesis)order of existing prosthesis-Meridium prosthesis-RoFT prosthesis |
| RoFT-Meridium | Active comparator | Device: Conventional ankle prosthesis, Device: Meridium® (Microprocessor ankle prosthesis), Device: RoFT® (Microprocessor ankle prosthesis)order of existing prosthesis-RoFT prosthesis-Meridium prosthesis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional ankle prosthesisAt 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-RoFT, RoFT-Meridium |
| 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 | Meridium-RoFT, RoFT-Meridium |
| 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®. | Device | Meridium-RoFT, RoFT-Meridium |
Primary outcome
Analysis of Changes in Three-dimensional motion during walking
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
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
Analysis of Changes in dynamic EMG during walking
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
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
Analysis of Changes in Energy consumption during walking
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
* 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.
Analysis of Changes in 6 minute walk test
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
* 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.
Analysis of Changes in Berg balance scale(BBS) scores
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
* 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
Analysis of Changes in Locomotor Capabilities Index (LCI) scores
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
* 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
Analysis of Changes in Korean-Prosthesis Evaluation Questionnaire (K-PEQ) scores
Time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis
* 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Results publication: PubMed 10567757Han 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.
- Results publication: PubMed 19932621Patterson 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.
- Results publication: PubMed 2211468Collen 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.
- Results publication: PubMed 15788341Flansbjer 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.
- Results publication: PubMed 1991946Podsiadlo 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.
- Results publication: PubMed 12720619Bischoff 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.
- Results publication: PubMed 28138492Hofheinz 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.
- Results publication: PubMed 18515291Nordin 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.
- Results publication: PubMed 12443950Schmalz 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.
- Results publication: PubMed 16442547Schache 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.
- Results publication: PubMed 9141121Gailey 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.
- Results publication: PubMed 4837552Winter 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.
- Individual participant dataSharing planned: No. No IPD sharing is planned for protection of privacy.
Related trials for Amputation
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Seung Yang, MD principal investigator
Veterans Health Service Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional ankle prosthesis, Meridium® (Microprocessor ankle prosthesis) and RoFT® (Microprocessor ankle prosthesis) in people with Amputation, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Yup Kim, MD (+821030385432, futurer22c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Changes in Three-dimensional motion during walking (time frame: (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04630457, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.