Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- The Assessment of Capacity for Myoelectric Control (ACMC)
研究概览
简要总结
The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years or older with upper limb absence at the transradial level while wearing a physical prosthesis.
The specific aims of this study are:
- To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.
- To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.
Researchers will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Participants will be assigned to a random test sequence that includes the following four different EMG channel conditions:
Condition A: 4 untargeted channels Condition B: 8 untargeted channels Condition C: Up to 16 untargeted channels Condition D: 8 targeted channels
Researchers will evaluate the effects of changing myoelectric channel counts on the functional prosthesis performance of individuals with transradial limb loss via functional outcome measures.
Participants will:
- Attend up to 5 in-lab sessions that are expected to last 4 hours.
- Conduct site visits every 1-2 weeks to complete functional and self reported outcome measures with each condition.
- Play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits.
详细描述
The objective of this study is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control, that have been established nearly exclusively on offline data analysis from able-bodied subjects, translates to functional performance when tested on persons with upper limb difference wearing a physical prosthesis.
The two prior assumptions that will be evaluated are: 1) there is no advantage to targeting myoelectric channels to specific muscle sites, and 2) there is no advantage to using more than 4-6 myoelectric channels for trans-radial prosthesis users.
The investigators will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Unlike much of the existing research, this study will test these configurations with subjects with limb absence controlling physical prosthetic arms to directly conduct activities of daily living.
The specific aims of this study are:
- To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the AMULA, ACMC, and Clothespin relocation tests (described below).
- To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the AMULA, ACMC, and Clothespin relocation tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •Unilateral transradial level limb absence
- •Current or past user of myo-electric controlled prostheses
- •Six months or more post-amputation
- •Have adequate limb length such that a wrist rotation device can fit in the check socket
- •Well-fitting socket as determined by a Socket-Comfort Score of 6 or above
- •Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand
- •Capable of understanding and following multi-step instructions and completing the tasks as described
- •English speaking
排除标准
- •Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- •Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
研究组 & 干预措施
Condition A: 4 untargeted channels
The 4-channel untargeted condition (Condition A) will utilize every fourth channel, and their location will be targeted at positions that are 'on the 45s' when examining a cross section of the forearm with the elbow bent to 90 degrees and the thumb pointed up.
This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.
干预措施: Experimental socket with 4 untargeted channels active (Device)
Condition B: 8 untargeted channels
The 8-channel condition (Condition B) will use the same channels as the 4-channel condition but add the four channels that bisect the original four channels.
This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.
干预措施: Experimental socket with 8 untargeted channels active (Device)
Condition C: Up to 16 untargeted channels
The 16-channel untargeted condition (Condition C) will utilize all 16 electrodes. Due to different limb sizes a full singular ring of 16 channels may not be possible on all human subjects. In these situations, the clinicians fabricating will use their best clinical judgement in order to fit as many electrode channels as possible onto the arm. If there is no reasonable way to fit 16 channels within the socket, then the maximum possible number of channels will be placed in the socket and the "16-channel" condition will be completed with the maximum number of available channels.
This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.
干预措施: Experimental socket with up to 16 untargeted channels active (Device)
Condition D: 8 targeted channels
This socket will use 8 targeted EMG channels identified and marked by the study prosthetist using Coapt's clinical instructions for identifying electrode sites. This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.
干预措施: Experimental socket with 8 targeted channels active (Device)
At-home Pattern Recognition Practice
The subject will use a commercially available EMG Coapt Cuff to practice pattern recognition while at home between study visits. They will be asked to play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits. The time between visits will be based on scheduling availability of the participant and study team but is expected to be approximately 1-2 weeks.
干预措施: Coapt EMG Cuff (Device)
结局指标
主要结局
The Assessment of Capacity for Myoelectric Control (ACMC)
时间窗: 4 hours
The ACMC is a performance-based assessment where trained raters observe the user performing a task and rate their ability to control specific hand movements. These movements are rated on a 4-point scale, ranging from "not capable" to "spontaneously capable". 0 = Not capable. 1 = Sometimes capable, capacity not established. 2 = Capable on request. 3 = Spontaneously capable. The items comprising the ACMC describe different levels of difficulty of control of the myoelectric hand. The items are grouped into 4 categories: gripping, holding, releasing, and coordinating between hands. The task that will be done for our study is packing a suitcase for a weekend trip. A higher score corresponds with a greater ability to control a myoelectric hand. This assessment will be done for each condition, each of which will be tested in visits 2-5.
次要结局
未报告次要终点