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临床试验/NCT04238533
NCT04238533Unknown不适用

Enhanced Auto-Diagnostic Adaptive Precision Trainer for Myoelectric Prosthetic Users

University of South Florida1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Compliance

研究概览

简要总结

The eADAPT training consists of a variety of mobile games played on a mobile app (phone or tablet). A band is worn on the residual limb. Participants use muscle activation to send signals to execute certain movements in the game.

详细描述

Myoelectric prostheses provide upper limb movement control using electromyography (EMG) electrodes on the residual muscles to control arm and hand movements. Within the current generation of advanced prostheses, research has shown that most amputees rely on assistive devices rather than prostheses (27 - 54% use prostheses), and many users do not use all available features or stop using the device altogether. Part of the difficulty in learning to control upper limb myoelectric prostheses stems from the sequences of muscle inputs required to choose grips and modes, and move the limb.

Myoelectric prosthetic limbs can aide in regaining lost capabilities, but require intensive training to effectively operate. Learning to use a myoelectric prosthesis involves significant motor cortex plasticity and learning how to consciously control muscle contraction, level of activation, and isolation through repetitive exercises. The need to concentrate and continuously react during training is expected to decrease with use, but often takes amputees many months, with the result being that many users abandon the prosthesis before mastery is achieved.

Difficult training has been identified as a primary reason for low user acceptance.

Current training methods and tools can be expensive, are limited in their activation sites, transferability, and personalized training capabilities. Current one-size-fits-all training cannot be personalized for the patient, thereby ignoring or being unresponsive to their learning ability. This limitation factor reduces the level of acute positive patient outcomes that can be achieved. A need therefore exists for myoelectric training tools that are affordable, reliable, support conventional and state-of-the-art control schemes, adaptable to various patient needs, can improve patient clinical outcomes, motivate patients to train, and be used in the clinic and remotely by the patient.

To fill the identified gaps in myoelectric training tools, Design Interactive, Inc. (DI) developed a prototype of the Auto Diagnostic Adaptive Precision Trainer for Myoelectric Prosthesis users (ADAPT-MP), an adaptive, game-based modular software solution paired with an innovative, mobile hardware solution to support the upper limb prosthesis training continuum, including basic pre-prosthetic training through advanced skill training using the prosthesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Amputation or missing limb at or above the wrist and below the elbow (transradial)
  • •Current myoelectric prosthesis user
  • •Sufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
  • •Sufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively;
  • •The patient is free of comorbidities that could interfere with the function of the prosthesis;
  • •Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual when performing activities of daily living
  • •Age 18-70 years
  • •Able to independently read, speak and understand English for the purpose of consent, following instructions and completing surveys

排除标准

  • •Amputation or missing limb at a level that is not above the wrist and below the elbow (transradial)
  • •Not currently a myoelectric user
  • •Insufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
  • •Insufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively
  • •The patient has comorbidities that could interfere with function of the prosthesis;
  • •Functional evaluation indicates that despite training, use of a myoelectric prosthesis is unlikely to meet the functional needs of the individual when performing activities of daily living;
  • •Age <18 or >70 years
  • •Participants with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the study procedure, or the ability to obtain relevant user feedback.
  • •Unable to independently read, speak and understand English for the purpose of consent, following instructions, and completing surveys

研究组 & 干预措施

eADAPT

Active Comparator

This arm includes transradial amputees who will be assessed while using the eADAPT trainer.

干预措施: eADAPT training (Other)

Conventional program

Active Comparator

This arm includes transradial amputees who will be assessed while using the conventional training program.

干预措施: Conventional training (Other)

结局指标

主要结局

Compliance

时间窗: 3 weeks

Compliance with the respective training protocol. For conventional exercise, patients will be contacted by phone once per week and asked if they were compliant with the training protocol. For the experimental (eADAPT) training protocol, utilization time will be recorded via the app and available for download for analysis. The difference in compliance between the two protocols will be compared.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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