Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Number of Participants With Significant Increases in Socket Comfort Score (SCS)
研究概览
简要总结
The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Transtibial amputees, unilateral or bilateral
- •Amputation at least 18 months prior
- •Walking activity of at least 7 hours per week
- •Medicare functional classification level of 2 or higher
- •Residual limb length of at least 9 centimeters
- •Detrimental impacts to socket fit caused by residual limb volume fluctuations
- •Indication for augmented suspension, socket modification/change, sock application removal or activity modification
排除标准
- •Incidence of skin breakdown
- •Inability to ambulate continuously on a level walkway
研究组 & 干预措施
Arm 1
In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
Arm 2 - Experimental
Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.
干预措施: Bioimpedance monitor (Device)
Arm 3 - Control
Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
结局指标
主要结局
Number of Participants With Significant Increases in Socket Comfort Score (SCS)
时间窗: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Participants are asked to quantify the overall comfort of their prosthesis by giving it a score between 0 and 10 with 0 as the least comfortable possible and 10 being the most comfortable possible. SCS scores were acquired both pre and post making modifications to the participant's prosthesis. For analysis purposes, the number of participants that had a significant positive change are counted for this outcome. Participants that had little to no change (a score difference \<2) in SCS or had a negative change in SCS score were not counted.
次要结局
- Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis(Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.)
- Number of Participants With Net-Positive Change in Ambulation Score(Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.)
- Number of Participants With Net-Positive Change in Residual Limb Health Score(Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.)
- Number of Participants With Net-Positive Change in Prosthesis Utility Score(Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.)
- Number of Participants With Net-Positive Change in Prosthesis Well Being Score(Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.)
- Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient(Baseline, prior to socket modification)
- Types of Socket Modifications Implemented Per Group(Baseline, prior to socket modification)
- Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit(Post modification, minimum 4 weeks after patient started study)
- Strategies Recommended to Minimize Limb Fluid Volume Loss(Post modification, minimum 4 weeks after patient started study)
- Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit(Post modification, minimum 4 weeks after patient started study)
- Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed(Post modification, minimum 4 weeks after patient started study)
- Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given(Post modification, minimum 4 weeks after patient started study)
- Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given(Post modification, minimum 4 weeks after patient started study)
- Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications(Post modification, minimum 4 weeks after patient started study)
- Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications(Post modification, minimum 4 weeks after patient started study)
- Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future(Post modification, minimum 4 weeks after patient started study)
- Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit(Post modification, minimum 4 weeks after patient started study)
- Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians(Post modification, minimum 4 weeks after patient started study)
- Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data(Post modification, minimum 4 weeks after patient started study)
- Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data(Post modification, minimum 4 weeks after patient started study)
研究者
Joan Sanders
Professor, Bioengineering
University of Washington