Home Study of an Advanced Upper Limb Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Change in Quality of Life (QOL) Scale
研究概览
简要总结
The overall study objective is to examine the feasibility, acceptance, and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage. All participating subjects will enroll in Part A of the study which will involve supervised training. Eligible subjects will be invited to participate in Part B, the home use portion of the study.
详细描述
The specific objectives of this study are to:
- identify and describe upper limb amputees who would be appropriate candidates for home use of this advanced prosthesis as well as those who would not be appropriate.
- Compare the extent of use of the existing prosthesis to that of the DEKA Arm.and quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities and the user's quality of life.
- Compare the outcomes of users of pattern recognition to the outcomes of users without
- quantify the amount and type of technical support and repairs needed during the study, and estimate the number of home study days lost due to service/repair.
All participating subjects will enroll in Part A of the study, which will involve supervised, in-laboratory training, as well as supervised community based outings. Based upon the findings from Part A, study staff will classify participants as appropriate or not appropriate for participation in Part B (the home usage portion of the study). Final determination of appropriateness for home use will be made after a home visit. The home use portion of the study will last for 13 weeks and involve regularly scheduled study visits.
Measures of existing prosthetic activity will be compared with those of home use of the advanced upper limb prosthetic device to determine the extent of adoption. Changes in device satisfaction, performance of functional activities, and quality of life will be evaluated throughout the study. Data on technical support usage will also be gathered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Inclusion Criteria (Parts A and B):
- •All subjects must be at least 18 years old and have single or bilateral upper limb amputation.
- •Subjects must be able to understand the requirements of the study and sign an Informed Consent Form and HIPAA Authorization Form.
- •Subjects will include those who are current users of any type of prosthetic device (body powered, electric or hybrid), non-users of devices who have been previously fit with a device, but have chosen not to wear it, as well as new users of devices.
- •To participate in the study all subjects must have active control over one or both ankles, OR have an appropriate number of myoelectric and/or other control sites (as determined by the Principal Investigator in conjunction with the research team) to allow adequate prosthetic controls configuration.
- •Inclusion Criteria Part B only:
- •Completion of all Part A study activities.
- •Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use.
排除标准
- •Exclusion Criteria (Parts A and B):
- •Amputees with elbow disarticulation, wrist disarticulation and partial hand amputations will be excluded. *beginning July 1, 2016 amputees with shoulder disarticulation or forequarter amputation will be excluded.
- •Amputees will be excluded if the length of their residual limb would prohibit socket fitting, as determined by the study prosthetist.
- •Persons with significant uncorrectable visual deficits that would impair the ability to see the prosthesis and those who have major communication or neurocognitive deficits will be excluded.
- •Persons with skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevented prior prosthetic wear will be excluded.
- •Persons with electrically controlled medical devices including pacemakers, and implanted defibrillators will be excluded.
- •Persons with neuropathy, uncontrolled diabetes, who are receiving dialysis, have insensate feet, severe phantom pain or a history of skin ulcers or any other significant comorbidity which would interfere with the study will be excluded.
- •Those with severe circulatory problems including peripheral vascular disease and pitting edema will be excluded.
- •Persons with cognitive deficits or mental health problems that would limit their ability to participate fully in the study protocol will be excluded.
- •Women who are pregnant or who plan to become pregnant in the near future will also be excluded.
- •The investigators will exclude those amputees who work for prosthetic companies that may be considered competitors for the prosthetic arm technology in the future.
- •Persons taking medication which poses a risk for operation of heavy equipment will be excluded.
研究组 & 干预措施
Advanced upper limb prosthetic device IMU controlled
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
干预措施: Advanced upper limb prosthetic device IMU controlled (Device)
Advanced upper limb prosthetic EMG-PR controlled
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
干预措施: Advanced upper limb prosthetic EMG-PR controlled (Device)
结局指标
主要结局
Change in Quality of Life (QOL) Scale
时间窗: baseline and after 9-12 weeks of home use (end of Part B)
The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B.
次要结局
- Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- Activities Measure for Upper Limb Amputees (AM-ULA)(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- Three Scales of the Veterans Version of the SF-36(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- Timed Measure of Activity Performance (T-MAP)(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))
- University of New Brunswick Test of Prosthetic Function (UNB)(Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B))