Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
2022年1月6日 更新者：Dorothy Barthélemy、Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
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.
研究概览
详细说明
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- Assessment 1 week after training
- 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).
研究类型
介入性
注册 (预期的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dorothy Barthélemy, PhD, PT
- 电话号码：514-343-7712
- 邮箱：dorothy.barthelemy@umontreal.ca
学习地点
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Quebec
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Montréal、Quebec、加拿大
- 招聘中
- Neuromobility lab
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接触：
- Dorothy Barthélemy, PhD, PT
- 电话号码：514-343-7712
- 邮箱：dorothy.barthelemy@umontreal.ca
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Combined explosive strength and specific balance training group
This group will be formed with participants with incomplete spinal cord injury.
This group will perform 4 weeks of combined explosive strength and specific balance training.
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Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations. Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements. Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:
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无干预：Spinal cord injury control group
This group will be formed with participants with incomplete spinal cord injury.
They will perform all the evaluation before and after a 4-week period of rest (no training).
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无干预：Healthy control group
Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in muscles EMG responses following balance perturbation
大体时间：Pre-intervention, immediately after and one-month after intervention
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Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
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Pre-intervention, immediately after and one-month after intervention
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Change in center of pressure displacement following balance perturbation using a force platform
大体时间：Pre-intervention, immediately after and one-month after intervention
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Excursion of centre of pressure will be analyzed following forward and backward perturbation.
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Pre-intervention, immediately after and one-month after intervention
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Change in ankle muscle strength using force transducer
大体时间：Pre-intervention, immediately after and one-month after intervention
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Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
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Pre-intervention, immediately after and one-month after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
大体时间：Pre-intervention, immediately after and one-month after intervention
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A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
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Pre-intervention, immediately after and one-month after intervention
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Change in the influence of peripheral afferents on cortical output using short-afference inhibition
大体时间：Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just after a peripheral electrical stimulation of tibial nerve to evaluate the peripheral afferents on cortical output.
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Pre-intervention, immediately after and one-month after intervention
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Change in the modulation of the H reflex by the corticospinal tract
大体时间：Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just before a tibial nerve stimulation to evaluate the modulation of the H reflex by the corticospinal tract.
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Pre-intervention, immediately after and one-month after intervention
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Change in EMG responses following vestibular stimulations during quiet standing
大体时间：Pre-intervention, immediately after and one-month after intervention
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Galvanic vestibular stimulation will be triggered during quiet standing.
EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
|
Pre-intervention, immediately after and one-month after intervention
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Change in the excursion of the center of pressure following vestibular stimulations
大体时间：Pre-intervention, immediately after and one-month after intervention
|
Galvanic vestibular stimulation will be triggered during quiet standing.
The displacement of the center of pressure will be analyzed using a force platform.
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Pre-intervention, immediately after and one-month after intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MOntreal Cognitive Assessment (MoCA) score
大体时间：Before enrollment
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The maximal score is 30 and minimal score 0.
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Before enrollment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年7月9日
初级完成 (预期的)
2022年12月1日
研究完成 (预期的)
2022年12月1日
研究注册日期
首次提交
2021年9月1日
首先提交符合 QC 标准的
2022年1月6日
首次发布 (实际的)
2022年1月20日
研究记录更新
最后更新发布 (实际的)
2022年1月20日
上次提交的符合 QC 标准的更新
2022年1月6日
最后验证
2022年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.