PlayBionic: Interactive Mobile Training App After Nerve Transfer or Amputation of the Upper Extremity
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Precision Control
研究概览
简要总结
Often prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train. To properly control a prosthesis, amputation patients must learn how to activate, isolate and sustain nerve signals to the muscles left at the stump. Results of clinical validations show that game-based training leads to an improvement in clinical parameters for prosthesis control and patient engagement.
详细描述
Relevance:
Many users of a myoelectric arm prosthesis do not use their device because they find it too difficult to control the prosthesis. This may be due to the fact that patients cannot contract their muscles in the residual limb in a sufficiently controlled manner. Exactly this circumstance is trained during the physiotherapy with the patients. But at home many patients lack the motivation to continue the exercises from physiotherapy. Mobile games on the smartphone can provide patients with long-term motivation to continue the repetitive exercises that prepare the muscles for controlling a prosthesis at home.
Aim:
The aim of this study is to support patients in training at home with a game on their smartphone. This should increase motivation and improve the ability to control a prosthesis efficiently.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transradial amputees are included in the study.
排除标准
- •Exclusion criterion is the inappropriate handling of the Android tablet or the computer ,as well as cyber sickness.
研究组 & 干预措施
MyoBeatz
The intervention consists of playing with the smartphone training program using the muscle signals picked up by surface electrodes. The study will run over a period of 5 weeks, with participants playing with the training program at home for 4 weeks.
干预措施: MyoBeatz (Behavioral)
结局指标
主要结局
Precision Control
时间窗: 30 minutes
Testing the patient's ability to precisely control their muscle contraction, given in percentage of target deviation. The Assessment of Precision Control evaluates the participant's fine EMG control accuracy. The range of this test was adapted based on the outcome of the MVC test. The participant is asked to reach 30 randomly preselected activation levels in the range of 10-90% of maximum voluntary contraction, and sustain them for 300 milliseconds each. The required level of activation is indicated by a triangular mark on the EMG bar. A total of 30 marks (3 trials consisting of 10 levels) are performed. The percentile deviation from the mark is taken as outcome measure.
Maximum Voluntary Contraction
时间窗: 10 minutes
Testing the patients voluntary myoelectric (EMG) contraction strength, given in millivolt (mV). This assessment is used as a calibration of the voltage detected by the electrodes. Participants are asked to maximally contract one muscle and to hold this contraction for 1.3 seconds, of which only the last second is taken for calculating the activation baseline.
Endurance Control
时间窗: 15 minutes
The Assessment of Endurance Control assesses muscle coordination and muscle fatigue while the participants used their EMG signals to closely follow a sine curve o 1/4 hertz on the screen until they feel fatigued. The estimated force needed to reach the peaks of the sine curve corresponds to 60% maximum voluntary contraction. Electrode activation needs to be separate to reach the peaks of the sine curve. The minimum time to be reached in this test is 5 minutes. The outcome measure is the EMG signal deviation from the desired sine curve, given as correlation r².
次要结局
- Phantom limb pain(At the beginning and at the end of the study (after 4 weeks))
研究者
Cosima Prahm
MSc, BA
Medical University of Vienna