跳至主要内容
临床试验/NCT04048083
NCT04048083Unknown不适用

Effect of Mental and Computer-aided Training of Reaching and Grasping Movements on Motor Control Processes in People With Bilateral Upper Limb Congenital Transverse Deficiency

Wroclaw University of Health and Sport Sciences2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年3月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
2
主要终点
Transcranial magnetic stimulation (TMS)

研究概览

简要总结

This project will explore a potentially powerful trainings that may be administered before upper extremity transplantation to induced plasticity of sensorimotor cortex in humans with congenital absence of upper limbs. We believe that engaging this population to computer-aided and/or mental trainings would facilitate structural and functional reorganization of the brain to promote motor function recovery.

详细描述

This project will explore a potentially powerful trainings that may be administered before upper extremity transplantation to induced plasticity of sensorimotor cortex in humans with congenital absence of upper limbs.

Our aim is to compare neurophysiological outcome of bilateral upper limb congenital transverse deficiency humans who are engaged in different types of training (mental-MT, computer-aided training-CAT and subjects receiving both type of trainings-CAMT). We hypothesize that all forms of training provide plastic changes in sensorimotor cortex. Specifically, we hypothesize that for CAMT group we will observe more prompt CNS-reorganization as compared to MT and CAT groups.

Our second aim is to examine mechanisms of neural and muscular system plasticity underlying neurophysiological function reorganization following the specific training and also to develop a computer system for training subjects through visual biofeedback. The control procedure of virtual upper extremity should be realized through recognition of intention of hand motion based on biosignals analysis.

Our protocol contains twelve weeks of trainings with three training sessions during a week (on Monday, Wednesday and Friday) and four measurement sessions (before the training period - PRE, after 4 weeks of trainings - POST4, after 8 weeks of trainings - POST8 and after 12 weeks of training - POST12).

Based on different methods we will use, we would like to ewaluate: structural changes in CNS, functional changes in CNS, functional changes in peripheral nervous system and functional changes in muscles of upper extremity stump by comparing results to the pre-training (PRE) values (with results from POST4, POST8 and POST12) and across the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • for patients:
  • Age between 18 and 25 years
  • Health status: bilateral upper limb congenital transverse deficiency individuals. Subjects must be free from neurological impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). All recruited subjects will be interviewed and their health status and medical history will be evaluated by a medical practitioner qualified to practice surgery and transplant surgery.
  • Training history: Subjects not participating in any type of training program in the last 5 years
  • Right Hemispheric Dominance. We will use Foot Dominance test - Observation of our subjects to see which foot they use to kick a ball, step up onto a stair, and step onto a coin placed on the floor.
  • Availability and interest: All candidates for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.

排除标准

  • for patients:
  • Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
  • Taking medication that affects the neuromuscular system
  • Left hemispheric dominance
  • Participation in training over the last five years
  • Inclusion Criteria for control subjects:
  • Age between 18 and 25 years
  • Health status: subjects must be free from neurological and neuromuscular system impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). ). All recruited subjects will be interviewed and their health status and medical history evaluated by neurologist.
  • Training history: subjects not participating in any type of training program in the last 5 years.
  • Hemispheric Dominance -right. We will use The Edinburgh inventory (Oldfield, 1971) and Foot Dominance test.
  • Availability and interest - All subjects for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.
  • Exclusion Criteria for control subjects:
  • Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
  • Taking medication that affects the neuromuscular system
  • Left hemispheric dominance
  • Participation in training over the last five years

结局指标

主要结局

Transcranial magnetic stimulation (TMS)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate excitability of the sensory-motor cortex of the brain.

Electroencephalography (EEG)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate functional changes in CNS, the 128-channels EEG will be used.

Electromyography (EMG)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate functional changes in muscles of upper extremity stump

Mechanomyography (MMG)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate functional changes in muscles of upper extremity stump

Functional Magnetic Resonance Imaging (fMRI)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate functional changes in CNS, the fMRI will be used

Near-infrared spectroscopy (NIRS)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate functional changes in peripheral nervous system.

Temperature measurements (Temp)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate functional changes in muscles of upper extremity stump

Magnetic Resonance Imaging (MRI)

时间窗: After 12 weeks of trainings period (POST12)

To evaluate structural changes in central nervous system (CNS) the MRI method will be used

次要结局

未报告次要终点

研究者

发起方
Wroclaw University of Health and Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaroslaw Marusiak

Co-Investigator

Wroclaw University of Health and Sport Sciences

研究点 (2)

Loading locations...

相似试验