A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- GaMA Cup Transfer Task Mean Completion Time
研究概览
简要总结
The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days. These individuals will be randomized to Group A (Control Group using conventional motor imagery exercises) and Group B (who will train with the MyoTrain AR system pre-prosthetically).
The investigators will test the following hypothesis: Pre-prosthetic training with the MyoTrain AR system, as compared to the current standard of care with conventional motor imagery exercises, results in improved subsequent control stability with the prosthesis.
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 repeat the functional assessment. Participants will then receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo a battery of validated, clinical assessments.
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 with a healed residual limb
- •Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study 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
GaMA Cup Transfer Task Mean Completion Time
时间窗: Day 35
The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.
GaMA Cup Transfer Task Mean Relative Grasp Duration
时间窗: Day 35
The percentage time spent in grasp phase relative to the entire movement (each movement involves reach-grasp-transport-release phases). This measure compensates for the expected inter-relation of absolute grasp duration with overall time, specifically identifying if grasp (object handling) is the main culprit in overall prolonged movement times.
次要结局
- Assessment of Capacity for Myoelectric Controls (ACMC)(Day 35)
- GaMA Cup Transfer Task Completion Rate(Day 35)
- GaMA Cup Transfer Task Wrist Activation(Day 35)
研究者
Rahul Kaliki
Chief Executive Officer
Infinite Biomedical Technologies