Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators

Официальное название

Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees

Обзор

The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are: * 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.

Подробное описание

This study aims to assess the effects of microprocessor-controlled prosthetic knees on fall-related health outcomes in prosthesis users classified as limited community ambulators. This study also seeks to expand the existing research on the potential microprocessor-controlled prosthetic knees (MPKs) have on improving health outcomes for patients who are classified as limited community ambulators (i.e., Medicare Functional Level K2). The investigators will examine whether the anticipated reduction in falls in K2 users is accompanied by improvements in fall-related health outcomes like fall-related anxiety, fall-related self-efficacy, fall-related avoidance behaviors, fall-related interference, and fewer falls. Investigators will also examine whether MPK use in the K2 population leads to increased mobility, increased walking speed, and improvements in health-related quality of life.

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF) [Срок оценки: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.]
• Prosthetic Limb Users Survey of Fall-Related Anxiety (PLUS-F-ANX) [Срок оценки: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.]
• Prosthetic Limb Users Survey of Fall-Related Avoidance Behaviors (PLUS-F-AVB) [Срок оценки: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.]
• Prosthetic Limb Users Survey of Fall-Related Interference (PLUS-F-INT) [Срок оценки: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.]
• Number of Reported Falls and Near-Fall Events [Срок оценки: Collected every two weeks starting at baseline up to 12 months]

Вторичные конечные точки (7)

• EuroQol 5 Dimensions (EQ-5D) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]
• Balance Recovery Scale (BRC) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]
• Fear of Falling Avoidance Behaviors Questionnaire (FFABQ) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]
• Prosthetic Limb Users Survey of Mobility (PLUS-M) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]
• Timed Up and Go (TUG) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]
• Ten Meter Walk Test (10mWT) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]
• Two Minute Walk Test (2MWT) [Срок оценки: Collected at baseline, 6-month, and 12-month assessments.]

Критерии участия

Критерии включения

• Unilateral transfemoral or knee disarticulation limb loss.
• 6 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:

• Houghton Score: 5-10
• Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes <49.45, otherwise, <36.75.
• Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
• Ability to read, write, and understand English.

Критерии исключения

• Any health condition that would prevent safely completing trial activities.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Hanger Inc. — Austin

Публикации

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• 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. PMID 16517347
• 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. PMID 24605197
• 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. PMID 21318011
• 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. PMID 24135259
• 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. PMID 19675993
• 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. PMID 17270519
• Jepson F, Datta D, Harris I, Heller B, Howitt J, McLean J. A comparative evaluation of the Adaptive knee and Catech knee joints: a preliminary study. Prosthet Orthot Int. 2008 Mar;32(1):84-92. doi: 10.1080/03093640701676376. PMID 18330807

Идентификаторы

NCT: NCT06937242 · UW-724 · CDMRP-CDMRP Log OP190025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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