Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in the modified Ashworth scale (MAS)
研究概览
简要总结
"Spinal cord injury (SCI) is a dramatic event resulting in a long-term handicap. Appropriate care from admission to the intensive care unit (ICU) is a key element not only for the survival of these patients but also to promote their recovery. Moreover, the studies on natural history of SCI have shown that most of the recovery occurs within the first 3 to 6 months post-injury. This period is therefore crucial for these patients. However, the environment of the ICU and the acute condition of the patients limit the rehabilitation possibilities. In such a context, functional proprioceptive stimulations (Vibramoov™ system, Techno Concept, France) could be a tool of interest.
By using tendon vibrations, the Vibramoov™ system allows to reproduce the proprioceptive signatures of cyclic movements such as walking. Some studies have already demonstrated the benefits of proprioceptive vibrations. However, so far, these benefits have only been studied at the chronic stage of neurological diseases.
The investigators hypothesized that early functional proprioceptive stimulations (FPS) may reduce spasticity and promote sensorimotor recovery in tetraplegic and high paraplegic patients.
To test their hypothesis, the investigators conduct a randomized controlled trial on 40 patients with traumatic SCI. These patients will be stratified into two groups according to the completeness of their lesion. Every patient will be included within ten days post-injury and receive either FPS, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. the primary outcome measures will assess spasticity. the investigators also assess sensorimotor recovery, pain, muscle wasting, cognitive impairment and functional status. "
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Traumatic Spinal Cord Injury at or above level T6
- •Age ≥ 18 years old
- •No pregnancy
- •Not being under guardianship
- •Be affiliated to the French social security system
排除标准
- •Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
- •Severe brain injury
结局指标
主要结局
Changes in the modified Ashworth scale (MAS)
时间窗: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
The MAS enables to assess spasticity. The muscle whose spasticity will be assessed are the soleus, gastrocnemius, knee extensors, knee flexors, adductors and gracilis (Score range from 0 to 5 per muscle, higher values represent a higher severity of spasticity)
Changes in the angles of the muscle reaction in the modified Tardieu scale (MTS)
时间窗: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
The MTS enables to assess the severity of spasticity. The muscle whose spasticity will be assessed are the soleus, gastrocnemius, knee extensors, knee flexors, adductors and gracilis (The outcome is reported in degree, from 0 to 180 degrees, higher values represent a higher dynamic component of spasticity)
Changes in the quality of the muscle reaction in the modified Tardieu scale (MTS)
时间窗: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
The muscle whose spasticity will be assessed are the soleus, gastrocnemius, knee extensors, knee flexors, adductors and gracilis (Score range from 0 to 5 per muscle, higher values represent a higher severity of spasticity)
Changes in the Spinal cord assessment tool for spastic reflexes (SCATS)
时间窗: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
This score enables to asses global spasticity (Score range from 0 to 18, higher values represent a higher degree of spasticity)
次要结局
- Changes in the visual analog scale for the auto-assessment of pain(Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury)
- Changes in the International standards for neurological classification of spinal cord injury (ISNCSCI) score(At inclusion, and at one week, one month, 2 months, 6 months and 1 year after the injury.)
- Number of days between the SCI and the verticalization at 45°(Verticalization is attempted progressively 3 times a week during the 8 weeks of treatment.)
- Number of days between the SCI and the verticalization at 70°(Verticalization is attempted progressively 3 times a week during the 8 weeks of treatment.)
- Changes in the Spinal cord independence measure (SCIM)(At 2 months, 6 months and 1 year after the injury)
- Changes in the digit span test to assess cognitive impairments(Up to 1 month, then at 2 months and 1 year after the injury)
- Changes in the visual analog scale for the auto-assessment of problematic spasticity(Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.)
- Changes in the nitrogen balance,(Every 48 hours during the first two weeks, and then once a week for six weeks)
- Changes in the time to complete the bells cancellation test to assess cognitive impairments(Up to 1 month, then at 2 months and 1 year after the injury)
- Changes in the number of omissions in the bells cancellation test to assess cognitive impairments(Up to 1 month, then at 2 months and 1 year after the injury)
- Changes in the quadriceps muscle thickness(At inclusion, then twice a week during the first month, and at 2 months, 6 months and 1 year after the injury)
- Changes in the Montreal cognitive assessment (MoCA)(Up to 1 month, then at 2 months and 1 year after the injury)