Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Intervention Feasibility
研究概览
简要总结
This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).
详细描述
This will be a randomized controlled trial with a limb-load biofeedback training (EXP) group and an attention control standard-of-care (CTL) group (2:1 allocation ratio). Outcomes will be assessed prior to surgery (Week 5), start of the limb-load biofeedback training (Week 24), and one year after surgery (Week 64). This Phase I clinical trial will be among the first randomized controlled rehabilitation trials for people with transfemoral OI prostheses. There is an immediate need to better understand the physical health benefits and factors that contribute to poor outcomes for this population. A critical step in developing rehabilitation guidelines is to identify optimal methods for people to regain active lifestyles, best use their prostheses, and avoid secondary comorbidities. This novel limb-load biofeedback training program will provide the empirical evidence necessary to inform post-OI rehabilitation regimens designed to optimize outcomes. Importantly, data from this trial will also guide intervention refinement as the investigators move toward a Phase II trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
- •≥ 18 years old
- •History of severe socket-related skin or residual limb problems
- •Schedule for OI prosthesis implantation surgery
排除标准
- •Vascular amputation etiology
- •Substance abuse
- •Unstable heart condition
- •Acute systemic infection
- •Cognitive impairment (Montreal Cognitive Assessment [MoCA] score <24)
- •Active cancer treatment
研究组 & 干预措施
Limb Load Biofeedback Training Intervention
The limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb loading symmetry. Participants randomized to the EXP group will receive 12 biofeedback training sessions (1 in-person, 11 telehealth) tapered over 40 weeks.
干预措施: Limb Load Biofeedback Training Intervention (Behavioral)
Attention Control Intervention
The CTL group intervention will include the same standard of care rehabilitation sessions as the EXP group and receive the same computer tablets for telehealth sessions as the EXP group. The CTL group will also have attention control educational sessions at the same frequency, timing, and duration as the EXP group limb-load biofeedback sessions (12 total sessions) with the first session being an in-person session at the Week 24. There will be no biofeedback training intervention in the CTL group. As such, there will be no behavioral intervention or wearable sensors provided to the CTL group. The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group.
干预措施: Attention Control (Other)
结局指标
主要结局
Intervention Feasibility
时间窗: Week 64
Intervention feasibility is measured by retention rate, the percentage of people that complete the study. A score can range between 0 and 100 percent with 100 percent meaning all randomized participants completed the study.
Intervention Fidelity
时间窗: Week 64
This will be evaluated based on whether EXP group interventionists deliver the intervention as planned and quantified in three ways: adherence, delivery quality, and patient engagement. The investigators will use the overall results of these three fidelity components to create a total score. Fidelity scores are reported as a percentage from 0 to 100 with 100 representing full fidelity. The investigators will consider \>85% fidelity (average across all three components) to intervention delivery as a positive result.
Change in Cumulative Loading
时间窗: Week 5, Week 64
Free-living physical activity will be objectively monitored over a 10-day period using an activPAL micro accelerometer-based sensor (PAL Technologies, Glasgow, UK). Interlimb cumulative loading will be measured as a product of daily step count and ground reaction force impulse. Cumulative loading = (Daily Steps/2)\*ground reaction force impulse.
Change in Multi-Domain Biomechanics during Tasks of Increasing Biomechanical Demand
时间窗: Week 5, Week 64
Bilateral hip movement patterns (joint angles), muscle forces, and joint reaction forces will be calculated during functional tasks of increasing biomechanical demand (walking, sitting, stepping, turning) using a combination of motion capture and subject-specific musculoskeletal models. Whole-body motion capture will be collected from 70 reflective markers (Fs=120 Hz) (Vicon, Centennial, CO) with ground reaction forces simultaneously collected from six embedded force platforms (Fs=2,160 Hz) (Bertec, Columbus, OH). A subject-specific musculoskeletal model will be created using OpenSim software.
Intervention Participant Acceptability
时间窗: Week 64
Acceptability of an intervention is the perception among stakeholders (e.g., patients and clinicians) that the intervention is agreeable or satisfactory. To measure participant acceptability, the investigators will use the Acceptability of Intervention Measure, a 30 four-item survey of stakeholder perception of intervention acceptability that asks participants to provide their approval as well as intervention appeal, likability, and agreeability. The scores range from 1 (completely disagree) to 5 (completely agree). The investigators expect the Acceptability of Intervention Measure score (average of the four items on a 1-5 scale) for the EXP group to be at least 4 (agree).
次要结局
- Change in 30 Second Sit - Stand Test(Week 5, Week 64)
- Change in World Health Organization-Disability Assessment Schedule 2.0(Week 5, Week 24 and Week 64)
- Change in Patient Specific Function Scale(Week 5, Week 24 and Week 64)
- Change in Prosthetic Limb Users Survey of Mobility(Week 5, Week 24 and Week 64)
- Change in Colorado Osseointegrated Limb Donning and Timed Up and Go Test(Week 5, Week 64)
- Change in Activities Specific Balance Confidence Scale(Week 5, Week 24 and Week 64)
- Change in Self Selected Gait Speed(Week 5 and Week 64)