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临床试验/NCT05200091
NCT05200091Unknown不适用

Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年7月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
36
试验地点
1
主要终点
Change in muscles EMG responses following balance perturbation

研究概览

简要总结

The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.

详细描述

After obtaining their consent, participants will undertake evaluations at different times:

  1. Assessment 1 week prior to training
  2. Training over 4 weeks (nature of the training depends on the group)
  3. Assessment 1 week after training
  4. Assessment 1 month after training (follow-up)

Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:

  • Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
  • Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.

After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • FOR PARTICIPANTS WITH SPINAL CORD INJURY
  • Inclusion Criteria:
  • Have an incomplete lesion of spinal cord
  • Level of spinal cord lesion between C5 and T12
  • At least, 6 months post-injury
  • Be considered as AIS C or D
  • Be able to stand without support for 15 seconds
  • Be able to provide informed consent in English or in French

排除标准

  • To have cognitive deficits
  • To have personal or family history of epilepsy
  • To have suffered moderate or severe traumatic brain injury
  • To have cochlear implant
  • FOR CONTROL PARTICIPANTS
  • Exclusion Criteria:
  • To have orthopedics problems
  • To have cognitive deficits
  • To have neurological problems

结局指标

主要结局

Change in muscles EMG responses following balance perturbation

时间窗: Pre-intervention, immediately after and one-month after intervention

Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.

Change in center of pressure displacement following balance perturbation using a force platform

时间窗: Pre-intervention, immediately after and one-month after intervention

Excursion of centre of pressure will be analyzed following forward and backward perturbation.

Change in ankle muscle strength using force transducer

时间窗: Pre-intervention, immediately after and one-month after intervention

Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.

次要结局

  • Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)(Pre-intervention, immediately after and one-month after intervention)
  • Change in the influence of peripheral afferents on cortical output using short-afference inhibition(Pre-intervention, immediately after and one-month after intervention)
  • Change in the modulation of the H reflex by the corticospinal tract(Pre-intervention, immediately after and one-month after intervention)
  • Change in EMG responses following vestibular stimulations during quiet standing(Pre-intervention, immediately after and one-month after intervention)
  • Change in the excursion of the center of pressure following vestibular stimulations(Pre-intervention, immediately after and one-month after intervention)

研究者

发起方
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorothy Barthélemy

Associate professor and researcher

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

研究点 (1)

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