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临床试验/NCT01608438
NCT01608438Unknown不适用

Motor Learning in a Customized Body-Machine Interface for Persons With Paralysis

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
157
试验地点
2
主要终点
Change in Time to task completion from Baseline at 8 months

研究概览

简要总结

People with tetraplegia often retain some level of mobility of the upper body. The proposed study will test the hypothesis that it is possible to develop personalized interfaces, which utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs and other assistive devices. If successful the project will result into the establishment of a new family of human-machine interfaces based on wearable sensors that adapt their functions to their users' abilities.

详细描述

The goal of these studies is to enable persons paralyzed by spinal cord injury (SCI) to drive powered wheelchairs and interact with computers by acting through an interface that maximizes the effectiveness of their residual motor function. This is called a "body-machine interface" because it maps the motions of the upper-body (arms and shoulders) to the space of device control signals in an optimal way. In this way, paralyzed persons that cannot operate a joystick controller because of lack of hand mobility can effectively use their whole upper body as virtual joystick device. An important characteristic of the proposed approach is that it is based on the possibility to control a computer or a wheelchair by bodily movements through an interactive learning process, in which the interface adapts itself to the subject's mobility and the subject learns to act through the interface. This study aims at developing and testing the customization of this interface to a group of SCI participants with tetraplegia, resulting from high-level cervical injury. The proposed research is organized in three specific aims:

(Aim 1) To develop new functional capabilities in persons with spinal cord injury by customizing a body-machine interface to their individual upper body mobility. After fitting the interface to the residual movements of each subject, participants will practice computer games aimed at training two classes of control actions: operating a virtual joystick and operating a virtual keyboard. This study will test the ability of the subjects to perform skilled maneuvers with a simulated wheelchair.

(Aim 2.) To test the hypothesis that practicing the upper-body control of personalized interfaces results in significant physical and psychological benefits after spinal-cord injury. A study will evaluate and quantify the impact of the practicing functional upper-body motions on the mobility of the shoulder and arms by conventional clinical methods and by measuring the subjects' ability to generate coordinated upper body movements and to apply isometric forces. Other studies under this aim will evaluate the effects of operating the body-machine interface on musculoskeletal pain and on the mood and mental state of the participants.

(Aim 3) To train spinal-cord injury survivors to skillfully operate a powered wheelchair using their enhanced upper body motor skills and customized interface parameters. Finally, the last study will test the hypothesis that the skills learned through practice in the virtual environment are retained for the control of an actual powered wheelchair. After reaching stable performance in the simulated wheelchair, subjects will practice the control of the physical wheelchair in safe a testing environment.

(Aim 4.) To understand how extensive practice with a body machine interface affects the cortical representation of the trained limbs. A study will evaluate and quantify the impact of the practicing functional upper-body motions on corticospinal excitability as a correlate to sensorimotor skill learning. Participants will meet the inclusion criteria for both the main study and satisfy the additional optional criteria. Participant will practice upper-body movements using the body-machine interface. The study will evaluate the evolution of corticospinal excitability in related areas of the motor cortex during the training compared to the baseline and after a follow-up period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

入选标准

  • Age 18-65
  • Injuries at C3-C6 level, complete (ASIA A) or incomplete (ASIA B and C)
  • Able to follow simple commands
  • Able to speak or respond to questions

排除标准

  • Presence of tremors, spasm and other significant involuntary movements
  • Cognitive impairment
  • Deficit of visuo-spatial orientation
  • Concurrent pressure sores or urinary tract infection
  • (Optional) Additional Exclusion Criteria for evaluation of corticospinal excitability using Transcranial Magnetic Stimulation:
  • Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body. This applies to all metallic hardware such as cochlear implants, or an Internal Pulse Generator or medication pumps, implanted brain electrodes, and peacemaker.
  • Personal history of epilepsy (untreated with one or a few past episodes), or treated patients
  • Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
  • Administration of drugs that potentially lower seizure threshold [62], without concomitant administration of anticonvulsant drugs which potentially protect against seizures occurrence
  • Change in dosage for neuro-active medications (Baclophen, Lyrica, Celebrex, Cymbalta, Gapapentin, Naposyn, Diclofenac, Diazapam, Tramadol, etc) within 2 weeks of any study visit.
  • Skull fractures, skull deficits or concussion within the last 6 months
  • unexplained recurring headaches
  • Sleep deprivation, alcoholism
  • Claustrophobia precluding MRI
  • Pregnancy

结局指标

主要结局

Change in Time to task completion from Baseline at 8 months

时间窗: Baseline and 8 months

The subjects will perform computer games requiring different data entry tasks (characters, cursor control) and navigate either a virtual or a real obstacle course. This primary outcome measure is the time it takes subjects to complete each task.

次要结局

  • Change in Movement Smoothness from Baseline at 8 months(Baseline and 8 months)
  • Change in Strength(Baseline and 8 months)
  • Change in Mental State(Baseline and 8 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferdinando Mussa-Ivaldi

Senior Research Scientist

Shirley Ryan AbilityLab

研究点 (2)

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