Determining the Functional Importance of a Powered Multifunction Wrist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
研究概览
简要总结
The focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. This study will enable the investigator to quantify the relative functional value of powered wrist flexion during both in-laboratory testing and home use. In addition, the investigators will address the effectiveness of different hand-wrist combinations to enhance patient-centered clinical decision making.
详细描述
The primary objective of this project is to evaluate the functional importance of a multi function wrist compared to a single degree of freedom wrist. This will be accomplished through in laboratory testing and an 8-week home trial. The first aim will involve in-laboratory functional performance testing with a 1-DOF or a 2-DOF wrist and a one degree of freedom hand.
Changes in performance will be assessed with multiple outcome measures that include both quantitative and qualitative testing of prosthesis control and functional performance. The second aim will determine how a 2-DOF wrist impacts control and home use of a one degree of freedom hand. Subjects will compete an 8 week home based trial. Participants will be instructed to complete a written home log of activities and electronic logging usage data will also be collected for each experimental condition. The investigators hypothesize that adding a wrist flexion/extension module to a wrist rotation module and a single-DOF terminal device will provide significant improvements in function for transradial amputees.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-95
- •A unilateral upper limb amputation or absence below the elbow
- •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 in order 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.
- •Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers
研究组 & 干预措施
Home Trial Condition A
Subject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand.
干预措施: Commercially available device (Device)
Home Trial Condition B
Subject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand.
干预措施: Non FDA registered device (Device)
结局指标
主要结局
Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
时间窗: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Measuring the function of upper limb prostheses is challenging and requires multiple test formats. A toolkit of functional outcome tests recommend by the Academy of Prosthetics and Orthotics ULPOM committee will be used to measure functional effectiveness of prosthetic treatment will be used as the primary outcome measure. The outcome measures to evaluate prosthesis use includes both quantitative and qualitative testing of prosthesis control and functional performance.
次要结局
- Patient Specific Functional Scale(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- Modified Box and Blocks Test of Manual Dexterity(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- Jebsen-Taylor Hand Function Test(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- Assessment of Capacity for Myoelectric Control (ACMC)(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- Clothespin Relocation Test(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- Orthotics and Prosthetics User Survey - Upper Extremity Function Status(Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B)
- Virtual Testing: Target Achievement Control Test(2 days)
研究者
Levi Hargrove
Director of the Center for Bionic Medicine
Shirley Ryan AbilityLab