Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
NCT ID: NCT06937242
Last Updated: 2025-04-24
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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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-30
2027-02-28
Brief Summary
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* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?
* Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?
Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.
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Detailed Description
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A 12-month, pragmatic randomized control trial (pRCT) will be conducted to assess whether MPKs improve fall-related health outcomes in unilateral, transfemoral or knee disarticulation prosthesis users classified as limited community ambulators.
Patients will be invited to participate in the trial as a part of their routine prosthetic care. If a patient agrees to participate and is eligible, a follow-up appointment will be scheduled, and the patient will be consented by the research study team. Participants will then be randomized to the intervention or control group. Participants in the control arm of the trial will remain in their prescribed prosthesis with a non-microprocessor knee (nMPK). Participants randomized to the intervention arm of the trial will have their nMPK exchanged for either a stance-and-swing MPK (Ottobock C-Leg 4) or a stance-only MPK (Ottobock Kenevo). The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria. Transfemoral prosthesis users walking up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive a stance-only MPK (Kenevo), while participants walking more than 0.83m/s in the 2MWT will receive a stance-and-swing MPK (C-Leg 4). Study participants will wear the knee for 12 months.
Each participant will be assessed at baseline (after enrollment and randomization), and 1-, 3-, 6-, 9-, and 12-months after baseline. The baseline and 12-month assessments will be the primary study time points. T-scores on the Prosthetic Limb Users Survey of Fall-Related Health (PLUS-F) and number of fall events experienced over the prior year will serve as the primary endpoints. Participants will complete a selected set of performance-based tests and standardized self-report surveys. In addition to the outcome measures noted, investigators will collect sociodemographic, health, amputation, fall history, and prosthesis information by self-report in order to characterize study participants and assess the comparability of the study groups. Fall-related health outcomes (e.g. fall-related self-efficacy and fall-related interference) will be measured using new PLUS-F instruments as well as existing measures that measure fall-related outcomes. We will also co-administer the Prosthetic Limb Users Survey of Mobility (PLUS-M) to assess participants' prosthesis-related mobility. Walking speed, mobility, endurance, and quality of life will be measured. For the 6- and 12-month assessments, we will also collect the hours of wear and hours of activity in the prosthesis.
Participants in both groups will receive education and training specific to their prosthetic knee between assessment 1 (baseline) and assessment 2 (one-month follow-up). Training will consist of 1 to 4 sessions to facilitate participants' use of their assigned prostheses. The number of sessions will be determined by the ability of each participant to explain and/or perform specified tasks. A standardized protocol and training checklist will be developed by our team Physical Therapist specific to each condition in collaboration with the knees' manufacturer (Ottobock). Every 2 weeks, throughout the 12 months of patient participation, the number of falls and near-fall events, including the event, injury, treatment and/or hospitalization, and whether the falls occurred while wearing the prosthesis, will be collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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MPK (Ottobock C-Leg 4 or Ottobock Kenevo)
The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria.
Ottobock C-Leg 4 Microprocessor Knee
Subjects in the intervention group who can walk more than 0.83m/s in the 2-minute walk test (2MWT) will receive the Ottobock C-Leg 4, a stance-and-swing microprocessor knee.
Ottobock Kenevo
Subjects in the intervention group who can walk up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive the Kenevo, a stance-only microprocessor knee.
nMPK
Participants in the control arm of the trial will remain in their prescribed non-microprocessor knee (nMPK) prosthesis
No interventions assigned to this group
Interventions
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Ottobock C-Leg 4 Microprocessor Knee
Subjects in the intervention group who can walk more than 0.83m/s in the 2-minute walk test (2MWT) will receive the Ottobock C-Leg 4, a stance-and-swing microprocessor knee.
Ottobock Kenevo
Subjects in the intervention group who can walk up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive the Kenevo, a stance-only microprocessor knee.
Eligibility Criteria
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Inclusion Criteria
* 12 months or longer since time of limb loss.
* Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.
* Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.
* Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).
* In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:
1. Houghton Score: 5-10
2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes \<49.45, otherwise, \<36.75.
3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
* Ability to read, write, and understand English.
Exclusion Criteria
* Any individuals that weigh 275 lbs or more.
* Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week
* Individuals with a history of acute or chronic residual limb breakdown
* Individuals with declining health status such that he/she subsequently reports reduced activity over the past 6 months
18 Years
ALL
No
Sponsors
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University of Washington
OTHER
U.S. Army Medical Research Acquisition Activity
FED
Hanger Institute for Clinical Research and Education, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Shane R. Wurdeman, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanger Institute for Clinical Research and Education
Locations
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Hanger Inc.
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Hu LY, Huang MW, Ke SW, Tsai CF. The distance function effect on k-nearest neighbor classification for medical datasets. Springerplus. 2016 Aug 9;5(1):1304. doi: 10.1186/s40064-016-2941-7. eCollection 2016.
Berry D. Microprocessor prosthetic knees. Phys Med Rehabil Clin N Am. 2006 Feb;17(1):91-113, vii. doi: 10.1016/j.pmr.2005.10.006.
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.
Eberly VJ, Mulroy SJ, Gronley JK, Perry J, Yule WJ, Burnfield JM. Impact of a stance phase microprocessor-controlled knee prosthesis on level walking in lower functioning individuals with a transfemoral amputation. Prosthet Orthot Int. 2014 Dec;38(6):447-55. doi: 10.1177/0309364613506912. Epub 2013 Oct 17.
Hafner BJ, Smith DG. Differences in function and safety between Medicare Functional Classification Level-2 and -3 transfemoral amputees and influence of prosthetic knee joint control. J Rehabil Res Dev. 2009;46(3):417-33.
Hafner BJ, Willingham LL, Buell NC, Allyn KJ, Smith DG. Evaluation of function, performance, and preference as transfemoral amputees transition from mechanical to microprocessor control of the prosthetic knee. Arch Phys Med Rehabil. 2007 Feb;88(2):207-17. doi: 10.1016/j.apmr.2006.10.030.
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Kahle JT, Highsmith MJ, Hubbard SL. Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference. J Rehabil Res Dev. 2008;45(1):1-14. doi: 10.1682/jrrd.2007.04.0054.
Pauley T, Devlin M, Heslin K. Falls sustained during inpatient rehabilitation after lower limb amputation: prevalence and predictors. Am J Phys Med Rehabil. 2006 Jun;85(6):521-32; quiz, 533-5. doi: 10.1097/01.phm.0000219119.58965.8c.
Wong CK, Chihuri ST, Li G. Risk of fall-related injury in people with lower limb amputations: A prospective cohort study. J Rehabil Med. 2016 Jan;48(1):80-5. doi: 10.2340/16501977-2042.
Pezzin LE, Dillingham TR, MacKenzie EJ. Rehabilitation and the long-term outcomes of persons with trauma-related amputations. Arch Phys Med Rehabil. 2000 Mar;81(3):292-300. doi: 10.1016/s0003-9993(00)90074-1.
McWhinnie DL, Gordon AC, Collin J, Gray DW, Morrison JD. Rehabilitation outcome 5 years after 100 lower-limb amputations. Br J Surg. 1994 Nov;81(11):1596-9. doi: 10.1002/bjs.1800811110.
van Velzen JM, van Bennekom CA, Polomski W, Slootman JR, van der Woude LH, Houdijk H. Physical capacity and walking ability after lower limb amputation: a systematic review. Clin Rehabil. 2006 Nov;20(11):999-1016. doi: 10.1177/0269215506070700.
Wong CK, Rheinstein J, Stern MA. Benefits for Adults with Transfemoral Amputations and Peripheral Artery Disease Using Microprocessor Compared with Nonmicroprocessor Prosthetic Knees. Am J Phys Med Rehabil. 2015 Oct;94(10):804-10. doi: 10.1097/PHM.0000000000000265.
Kim J, Major MJ, Hafner B, Sawers A. Frequency and Circumstances of Falls Reported by Ambulatory Unilateral Lower Limb Prosthesis Users: A Secondary Analysis. PM R. 2019 Apr;11(4):344-353. doi: 10.1016/j.pmrj.2018.08.385. Epub 2019 Jan 15.
Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.
Gauthier-Gagnon C, Grise MC, Potvin D. Enabling factors related to prosthetic use by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 1999 Jun;80(6):706-13. doi: 10.1016/s0003-9993(99)90177-6.
Legro MW, Reiber G, del Aguila M, Ajax MJ, Boone DA, Larsen JA, Smith DG, Sangeorzan B. Issues of importance reported by persons with lower limb amputations and prostheses. J Rehabil Res Dev. 1999 Jul;36(3):155-63.
Highsmith MJ, Kahle JT, Bongiorni DR, Sutton BS, Groer S, Kaufman KR. Safety, energy efficiency, and cost efficacy of the C-Leg for transfemoral amputees: A review of the literature. Prosthet Orthot Int. 2010 Dec;34(4):362-77. doi: 10.3109/03093646.2010.520054. Epub 2010 Oct 24.
Sawers AB, Hafner BJ. Outcomes associated with the use of microprocessor-controlled prosthetic knees among individuals with unilateral transfemoral limb loss: a systematic review. J Rehabil Res Dev. 2013;50(3):273-314. doi: 10.1682/jrrd.2011.10.0187.
Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol). 2018 Oct;58:116-122. doi: 10.1016/j.clinbiomech.2018.07.012. Epub 2018 Jul 19.
Stevens PM, Wurdeman SR. Prosthetic Knee Selection for Individuals with Unilateral Transfemoral Amputation: A Clinical Practice Guideline. J Prosthet Orthot. 2019 Jan;31(1):2-8. doi: 10.1097/JPO.0000000000000214. Epub 2018 Nov 9.
Kannenberg A, Zacharias B, Probsting E. Benefits of microprocessor-controlled prosthetic knees to limited community ambulators: systematic review. J Rehabil Res Dev. 2014;51(10):1469-96. doi: 10.1682/JRRD.2014.05.0118.
Related Links
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(CMS), U. S. C. f. M. m. S. Lower limb prosthetic workgroup consensus document (September 2017).
Other Identifiers
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CDMRP-CDMRP Log OP190025
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UW-724
Identifier Type: -
Identifier Source: org_study_id
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