Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Sep 20, 2024
  • participants needed
    40
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 2 November 2021
spasticity
spinal cord
spinal cord disorder

Summary

"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. "

Details
Condition Wounds, Trauma, Spinal Cord Injuries, Spinal Cord Disorders, Myelopathy, Spinal Cord Injury
Treatment Proprioceptive stimulations, Sham stimulations
Clinical Study IdentifierNCT05094752
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on2 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
Severe brain injury
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