Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ)
研究概览
简要总结
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.
This study will compare the use of Glide [Experimental] prosthesis with a DC [Standard] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.
详细描述
Recruitment and group assignment: Participants will be recruited through one of Arm Dynamics's six Centers of Excellence. Potentially eligible participants will be identified by their care team and referred to a study team member to go over the details of the patient's involvement and the study protocol. After informed consent and medical clearance are completed, the study prosthetist and occupational therapist will meet with the participant and identify functional goals for their prosthesis. The prosthetist will then begin fabricating the prosthesis. A single prosthesis will be fabricated for use with both control strategies. Switching between control methods will be done through the Glide iPad application. Once fabrication is completed, a clinical team member will configure the assigned control strategy with the subject to achieve maximum functional efficiency.
Prosthesis delivery and occupational therapy (Day 0): After the consenting process and group assignment, patients will return to the clinic to be fit with the prosthesis. Each prosthetic system will include IBT's Glide system, remote electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The Glide system also allows for Direct Control of the prosthesis without any hardware change, as long as two of the remote electrodes are positioned according to Direct Control site selection. The fitting process may take multiple visits to adjust the socket. The participant will be given instructions on how to use their prosthesis and activate the various functions of their initial device. Occupational therapy (OT) will be provided over 2 days to the patient to help patients accomplish their desired activities of daily living. At the conclusion of OT, participants will complete baseline assessments of the CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM measures.
Phase I DC prosthesis: Over the course of the next 5-, 6-, or 7-weeks, subjects will use their DC prosthesis during their everyday lives. The Glide system is capable of recording usage data during these at-home periods (regardless of which control system is active at a given time). These measures include the Daily Mean Number of Movement Bouts (DMNMB). Using a web portal submission, subjects will report the DMNMB and their Mean Prosthesis Wear Duration (MPWD) for the previous week. At this time, subjects will also complete the CAPROQ and FIT surveys. This data submission will occur weekly.
Phase I Midpoint: Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, the subject will continue Phase I.
Phase I DC prosthesis: Phase I procedures will be repeated (DC prosthesis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Trans-radial unilateral limb loss
- •Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist
- •Minimal residual limb length for myoelectric control as determined by the clinical team
- •Age of 18 years or greater
排除标准
- •Patients with a residual limb that is unhealed from the amputation surgery
- •Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- •Unhealed wounds
- •Significant cognitive deficits as determined upon clinical evaluation
- •Significant neurological deficits as determined upon clinical evaluation
- •Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- •Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
- •Serious uncontrolled medical problems as judged by the project therapist
研究组 & 干预措施
Multiple Baseline
Participants act as their own controls. Participants are fit with a prosthesis system, which includes IBT's Core2 controller, IBT Electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The provided controller can operate in two modes of operation: (1) in Direct Control (or DC); and (2) using the Glide control strategy. Participants progress through an AB multiple baseline protocol, where they use the provided prosthesis system for four evaluation periods (totaling 24-weeks in duration). During the A-phase, participants use the system with DC and during the B-phase, participants use the system with the Glide control strategy. For both interventions, the required hardware is the same, while the control software will differ.
干预措施: Glide (Device)
Multiple Baseline
Participants act as their own controls. Participants are fit with a prosthesis system, which includes IBT's Core2 controller, IBT Electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The provided controller can operate in two modes of operation: (1) in Direct Control (or DC); and (2) using the Glide control strategy. Participants progress through an AB multiple baseline protocol, where they use the provided prosthesis system for four evaluation periods (totaling 24-weeks in duration). During the A-phase, participants use the system with DC and during the B-phase, participants use the system with the Glide control strategy. For both interventions, the required hardware is the same, while the control software will differ.
干预措施: Direct Control (Device)
结局指标
主要结局
Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ)
时间窗: Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161 and Day 168)
CAPROQ is a validated patient reported outcome measure that captures key facets of rehabilitation for adults with UL absence or loss: perceived function, satisfaction, and pain. CAPROQ includes a total of 28 questions spread across three sub-scales: 8 satisfaction, 10 perceived functioning, and 10 pain subcategory questions. Responses to all questions are given on a 10-point, Likert-type scale. Higher scores therefore indicate higher levels of overall satisfaction. A singular total CAPROQ score is derived by standardizing each of the CAPROQ subscales and summing these standardized scores together. Higher total scores on the CAPROQ indicate better rehabilitation outcomes and reflect the individual's perceived success with their prosthesis and rehabilitation; specifically, satisfaction with their prosthesis and rehabilitation, greater functional performance, and lesser pain. CAPROQ scores range from 0 to 100.
次要结局
- Targeted Box and Blocks Tests (tBBT)(Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168))
- Mean Prosthesis Wear Duration (MPWD)(Daily (i.e., Day 0, Day 1, Day 2, ..., Day 167, Day 168))
- Capacity Assessment of Prosthesis Performance of the Upper Limb (CAPPFUL)(Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168))
- Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire(Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168))
- Speed and Accuracy Measurement(Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168))
- Daily Mean Number of Movement Bouts (DMNMB)(Daily (i.e., Day 0, Day 1, Day 2, ..., Day 167, Day 168))
- FIT Survey(Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161, and Day 168))
研究者
Rahul Kaliki
Chief Executive Officer
Infinite Biomedical Technologies