Safety and Effectiveness of Electronically Controlled Prosthetic Ankle
NCT ID: NCT04630457
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2020-10-20
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Meridium-RoFT
order of existing prosthesis-Meridium prosthesis-RoFT prosthesis
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.
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®.
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®.
RoFT-Meridium
order of existing prosthesis-RoFT prosthesis-Meridium prosthesis
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.
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®.
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®.
Interventions
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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.
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®.
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®.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Chungnam National University Hospital
OTHER
Veterans Health Service Medical Center, Seoul, Korea
OTHER
Responsible Party
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Jun Yup Kim, MD
Primary Researcher
Principal Investigators
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Hee Seung Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Veterans Health Service Medical Center, Seoul, Korea
Locations
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Veterans Health Service Medical Center, Seoul, Korea
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hee Seung Yang, MD
Role: primary
Pyung Hwa Choi, PhD
Role: backup
References
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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.
Other Identifiers
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2020-08-011
Identifier Type: -
Identifier Source: org_study_id