Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
The randomization plan will be hidden from investigators responsible for enrolling and consenting study participants. The prosthetist and participant will be unblinded to assignment following enrollment. It is not feasible to blind participants throughout the study due to key differences in the intervention and control devices (e.g., the MPK requires daily charging, but the NMPK does not).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
- •Ability to read, write, and understand English.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ottobock C-Leg 4 Microprocessor Knee (Device)
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.
干预措施: Ottobock Kenevo (Device)
nMPK
Participants in the control arm of the trial will remain in their prescribed non-microprocessor knee (nMPK) prosthesis
结局指标
主要结局
Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF)
时间窗: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
The PLUS-F-SEF is a 15-item self-report instrument we developed in the present study to measure perceived ability to avoid a loss of balance while performing an activity. Respondents rate their degree of confidence on a 5-point scale from "not at all confident" (1) to "very much confident" (5). A standardized T-score is generated for the PLUS-F-SEF using a lookup table that converts the raw score to a T-score.
Prosthetic Limb Users Survey of Fall-Related Anxiety (PLUS-F-ANX)
时间窗: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
The PLUS-F-ANX is a 15-item self-report instrument we developed in the present study to measure perceived apprehensions or concerns about losing one's balance or falling. Respondents rate the frequency with which they experience various emotional responses on a 5-point scale from "never" (1) to "always" (5). A standardized T-score is generated for the PLUS-F-ANX using a lookup table that converts the raw score to a T-score.
Prosthetic Limb Users Survey of Fall-Related Avoidance Behaviors (PLUS-F-AVB)
时间窗: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
The PLUS-F-AVB is a 15-item self-report instrument we developed in the present study to measure perceived changes in the manner or frequency with which activities are performed to avoid losing one's balance or falling. Respondents rate the frequency with which they make changes on a 5-point scale from "never" (1) to "always" (5). A standardized T-score is generated for the PLUS-F-AVB using a lookup table that converts the raw score to a T-score.
Prosthetic Limb Users Survey of Fall-Related Interference (PLUS-F-INT)
时间窗: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments.
The PLUS-F-INT is a 15-item self-report instrument we developed in the present study to measure perceived restrictions in social, cognitive, emotional, and/or physical life situations due to risk of falls. Respondents rate the amount of interference on a 5-point scale from "not at all" (1) to "very much" (5). A standardized T-score is generated for the PLUS-F-INT using a lookup table that converts the raw score to a T-score.
Number of Reported Falls and Near-Fall Events
时间窗: Collected every two weeks starting at baseline up to 12 months
Participants will be contacted every 2 weeks starting at baseline through study completion to determine whether they experienced a fall event (either a fall or near-fall). For each event experienced, participants will be asked to report the details of that event using the Lower Limb Prosthesis User Fall Event Survey we developed in a prior study. This instrument asks respondents to report the activity, surroundings, situation, mechanics, and consequences of each event. Fall events will be scored as the total number of falls, near-falls, and all fall events experienced. The details of the events are descriptive in nature and will be used to characterize the falls experienced by the participant.
次要结局
- EuroQol 5 Dimensions (EQ-5D)(Collected at baseline, 6-month, and 12-month assessments.)
- Balance Recovery Scale (BRC)(Collected at baseline, 6-month, and 12-month assessments.)
- Fear of Falling Avoidance Behaviors Questionnaire (FFABQ)(Collected at baseline, 6-month, and 12-month assessments.)
- Prosthetic Limb Users Survey of Mobility (PLUS-M)(Collected at baseline, 6-month, and 12-month assessments.)
- Timed Up and Go (TUG)(Collected at baseline, 6-month, and 12-month assessments.)
- Ten Meter Walk Test (10mWT)(Collected at baseline, 6-month, and 12-month assessments.)
- Two Minute Walk Test (2MWT)(Collected at baseline, 6-month, and 12-month assessments.)