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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Chungnam National University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meridium-RoFT | Active Comparator | order of existing prosthesis-Meridium prosthesis-RoFT prosthesis |
|
| RoFT-Meridium | Active Comparator | order of existing prosthesis-RoFT prosthesis-Meridium prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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
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.
| (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 |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Yup Kim, MD | Contact | +821030385432 | futurer22c@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee Seung Yang, MD | Veterans Health Service Medical Center, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Health Service Medical Center, Seoul, Korea | Recruiting | Seoul | 05368 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10567757 | Result | 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. | |
| 19932621 | Result | 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. |
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No IPD sharing is planned for protection of privacy.
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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).
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| 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®. |
|
| (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 |
| (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 |
| (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 |
| (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 |
| (1st visit, day 1)existing conventional prosthesis - (2nd visit, day 15)1st Microprocessor ankle prosthesis - (3rd visit, day 29) 2nd Microprocessor ankle prosthesis |
| 2211468 | Result | 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. |
| 15788341 | Result | 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. |
| 1991946 | Result | 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. |
| 12720619 | Result | 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. |
| 28138492 | 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. |
| 18515291 | Result | 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. |
| 12443950 | 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. |
| 16442547 | 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. |
| 9141121 | 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. |
| 4837552 | 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. |