User-driven Retrospectively Supervised Classification Updating (RESCU) System for Robust Upper Limb Prosthesis Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Mean Daily Prosthesis Use Duration
研究概览
简要总结
This study will compare the use of RESCU [Experimental] Prosthesis with a [Standard] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.
详细描述
The AB sequence for the study protocol is described below, where control type A is the Standard prosthesis and control type B is the Experimental prosthesis.
On Day 0, the participant will be evaluated with the Standard prosthesis. A series of Measures (as defined in the next paragraph) will then be recorded. The participant will then take the prosthesis home for one week, and daily use data will be recorded. The participant will return to the clinic for Day 7 Measures and download of the daily use data. During this session, the participant will be fit with the second system, undergo occupational therapy in the clinic, and Measures will be recorded. There will be no washout period as the prosthesis is expected to be in daily use. The participants will go home for a four-week period and return on Day 35 for a third set of Measures. At this time, the participant will be asked which prosthesis he/she prefers.
There are limited functional outcome assessment options for the planned comparison. However, the investigators will test functional measures at the clinic appointments, examine daily use data, and administer several qualitative surveys to assess participant outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The occupational therapist who graded the AM-ULA functional assessment was masked to participant IDs and intervention
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
- •Trans-radial limb difference.
- •Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
- •Active pattern recognition myoelectric prosthesis user
- •Fluent in English
- •Age of 18 years or greater
排除标准
- •Patients with a residual limb that is unhealed from the amputation surgery
- •Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- •Unhealed wounds
- •Significant cognitive deficits as determined upon clinical evaluation
- •Significant neurological deficits as determined upon clinical evaluation
- •Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- •Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
- •Serious uncontrolled medical problems as judged by the project therapist
结局指标
主要结局
Mean Daily Prosthesis Use Duration
时间窗: Baseline, 4 weeks
Prosthesis usage time was monitored as a proxy for user satisfaction, under the assumption that when an individual is more satisfied with their prosthetic solution, they will use it more in their daily lives. For the experimental intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily over the evaluation period (i.e., four weeks). For the control intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily before the evaluation period (i.e., at baseline).
次要结局
- Trinity Amputation and Prosthesis Experience Survey for Upper Limb Amputation (TAPES-ULA)(Baseline, Post-Intervention)
- Orthotics and Prosthetics User's Survey Upper Extremity Functional Status (OPUS UEFS)(Baseline, Post-Intervention)
- Pain Scale(Baseline, Post-Fitting, Post-Intervention)
- Socket Comfort Score(Baseline, Post-Fitting, Post-Intervention)
- Range of Motion (of Residual Joints)(Baseline, Post-Fitting)
- Activities Measure for Upper Limb Amputees (AM-ULA)(Baseline, Post-Fitting, Post-Intervention)
- PROMIS Satisfaction Short Form 8a(Baseline, Post-Intervention)
研究者
Rahul Kaliki
Chief Executive Officer
Infinite Biomedical Technologies