Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mean Prosthesis Wear Duration
研究概览
简要总结
The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system).
The investigators will test three hypotheses:
- The use of MyoTrain results in skills transference to control of the final prosthesis
- The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures
- The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics
Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Trans-radial unilateral limb loss
- •Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist
- •Fluent in English
- •Age of 18 years or greater
排除标准
- •Prior experience with pattern recognition control
- •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 impactive full participation in the study as determined upon clinical evaluation
- •Serious uncontrolled medical problems as judged by the project therapist
结局指标
主要结局
Mean Prosthesis Wear Duration
时间窗: Days 35-206
Investigators will measure the mean duration of daily prosthesis wear as a proxy for improved prosthesis acceptance. Prosthesis wear time is defined as the time from when participants dons their prostheses to the time they doff their prostheses. The time points are detected by skin-electrode impedance measurements through the EMG electrodes.
次要结局
- Clothespin Relocation Test (CRT)(Days 31, 35, 93, 149, and 206)
- Assessment of Capacity for Myoelectric Control (ACMC)(Days 31, 35, 93, 149, and 206)
- Module 2 of MyoTrain(Days 0, 31, 35, 93, 149, and 206)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(Days 0, 31, 35, 93, 149, and 206)
- Daily Mean Number of Movement Bouts(Days 35-206)
研究者
Rahul Kaliki
Chief Executive Officer
Infinite Biomedical Technologies