Comparing the Attentional Demands and Functional Outcomes of Pattern Recognition and Direct Myoelectric Control in People With Transradial Amputation
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
- Refined Clothespin Relocation Test (rCRT)
研究概览
简要总结
Different ways of controlling an upper-limb prosthesis can affect how easy it is to use and how helpful it is in everyday activities. One common method, called direct control, uses signals from two muscles and can make switching between movements difficult. Another clinically available option, called pattern recognition control, uses signals from several muscles to better understand the user's intended movement and may feel more natural to use. This study compares these two control methods to see how they affect function for adults with below-the-elbow limb loss.
详细描述
Pattern recognition controller (PRC) systems for upper-limb prostheses are a clinically established alternative to conventional direct control (DC) systems. For decades, two-site DC has been the primary method for controlling myoelectric upper-limb prosthetic devices. DC relies on surface electromyography (EMG) recordings from two control sites, typically an antagonistic muscle pair in the residual limb, and uses relative signal amplitude to generate movement commands for the prosthesis.
PRC is a more recent, clinically established control strategy developed to address several limitations associated with DC. Rather than depending on isolated activation of two muscle sites, PRC captures EMG signals from multiple sensors across the residual limb and uses pattern-classification algorithms to identify the user's intended movement. By incorporating information from multiple EMG channels, PRC may provide more intuitive and natural control, support a broader range of wrist and terminal device motions, and reduce reliance on non-intuitive switching strategies-particularly during tasks requiring rapid transitions between movements. PRC systems also enable on-demand recalibration, allowing users to adjust control performance in response to day-to-day changes in socket fit or electrode positioning.
Although both PRC and DC systems are clinically established and have been used in practice, this study provides an opportunity to directly compare two clinically established control strategies. This trial will evaluate the functional advantages and disadvantages of PRC relative to DC when used by adults with unilateral transradial limb loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years of age or older
- •Unilateral transradial limb loss
- •At least 6 months since loss
- •Previous or current use of a myoelectric device for 3 months or longer
- •Use of a prosthesis at least 4 days each week
- •Ability to read, write, and understand English
- •Willingness to use each control strategy as primary device for 3 months each (6 months commitment total)
排除标准
- •Any health condition that would prevent safely completing trial activities
- •Discontinued use of a myoelectric prosthesis due to non-financial reasons
研究组 & 干预措施
Pattern recognition controller (PRC) arm method intervention first and then the DC intervention
Participants randomized to this condition will first try the PRC controller for 3 months. Afterwards, participants will try the DC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: Training with DC (Device)
Pattern recognition controller (PRC) arm method intervention first and then the DC intervention
Participants randomized to this condition will first try the PRC controller for 3 months. Afterwards, participants will try the DC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: DC Device use in community and home (Device)
DC intervention first and then the Pattern recognition controller (PRC) arm method intervention
Participants randomized to this condition will first try the DC controller for 3 months. Afterwards, participants will try the PRC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: Training with PRC (Device)
Pattern recognition controller (PRC) arm method intervention first and then the DC intervention
Participants randomized to this condition will first try the PRC controller for 3 months. Afterwards, participants will try the DC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: Training with PRC (Device)
Pattern recognition controller (PRC) arm method intervention first and then the DC intervention
Participants randomized to this condition will first try the PRC controller for 3 months. Afterwards, participants will try the DC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: PRC Device use in community and home (Device)
DC intervention first and then the Pattern recognition controller (PRC) arm method intervention
Participants randomized to this condition will first try the DC controller for 3 months. Afterwards, participants will try the PRC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: Training with DC (Device)
DC intervention first and then the Pattern recognition controller (PRC) arm method intervention
Participants randomized to this condition will first try the DC controller for 3 months. Afterwards, participants will try the PRC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: PRC Device use in community and home (Device)
DC intervention first and then the Pattern recognition controller (PRC) arm method intervention
Participants randomized to this condition will first try the DC controller for 3 months. Afterwards, participants will try the PRC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions.
干预措施: DC Device use in community and home (Device)
结局指标
主要结局
Refined Clothespin Relocation Test (rCRT)
时间窗: Collected at Baseline, 3-Month, and 6-Month Assessments
The rCRT measures upper limb prosthesis performance. The test requires participants to rotate each clothespin 90° before placing it onto the vertical bar, which necessitates use of more than one joint motion. Faster completion times are indicative of superior prosthesis control and dexterity.
Clothespin Relocation Test (CRT)
时间窗: Collected at Baseline, 3-Month, and 6-Month Assessments
The CRT measures upper limb prosthesis performance. The test requires participants to rotate each clothespin 90° before placing it onto the vertical bar, which necessitates use of more than one joint motion. Faster completion times are indicative of superior prosthesis control and dexterity. This will be completed under single-task and dual-task conditions.
次要结局
- Prosthesis Task Load Index (PROS-TLX)(Collected at Baseline, 3-Month, and 6-Month Assessments)
- PROMIS® Upper Extremity Function - 9-item(Collected at Baseline, 3-Month, and 6-Month Assessments)
- Prosthetic Limb Users Survey of Upper Limb Attention (PLUS-Au)(Collected at Baseline, 3-Month, and 6-Month Assessments)
- PROMIS® Upper Extremity Function - 9-item(6 Months (During the course of the study procedures/participation))
- Prosthetic Limb Users Survey of Upper Limb Attention (PLUS-Au)(6 Months (During the course of the study procedures/participation))
- Brief Activity Measure for Upper Limb Amputees (BAM-ULA)(Collected at Baseline, 3-Month, and 6-Month Assessments)
- Jebsen-Taylor Hand Function Test (JTHF)(Collected at Baseline, 3-Month, and 6-Month Assessments)
- Orthotic and Prosthetic Users Survey (UEFS-P)(Collected at Baseline, 3-Month, and 6-Month Assessments)
- Patient Experience Measure (PEM)(Collected at Baseline, 3-Month, and 6-Month Assessments)
- Prosthetic Arm Control Survey (PACS)(Collected at Baseline, 3-Month, and 6-Month Assessments)