Clinical trial NCT05094752: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury
Official title: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injuries
quadriplegia
proprioceptive stimulation
vibration
spasticity
intensive care units
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. "


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the modified Ashworth scale (MAS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the angles of the muscle reaction in the modified Tardieu scale (MTS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the quality of the muscle reaction in the modified Tardieu scale (MTS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the Spinal cord assessment tool for spastic reflexes (SCATS)
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
Secondary outcomes:
measure: Changes in the visual analog scale for the auto-assessment of problematic spasticity
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.
measure: Changes in the visual analog scale for the auto-assessment of pain
timeFrame: Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury
measure: Changes in the International standards for neurological classification of spinal cord injury (ISNCSCI) score
timeFrame: At inclusion, and at one week, one month, 2 months, 6 months and 1 year after the injury.
measure: Changes in the quadriceps muscle thickness
timeFrame: At inclusion, then twice a week during the first month, and at 2 months, 6 months and 1 year after the injury
measure: Changes in the nitrogen balance,
timeFrame: Every 48 hours during the first two weeks, and then once a week for six weeks
measure: Number of days between the SCI and the verticalization at 45°
timeFrame: Verticalization is attempted progressively 3 times a week during the 8 weeks of treatment.
measure: Number of days between the SCI and the verticalization at 70°
timeFrame: Verticalization is attempted progressively 3 times a week during the 8 weeks of treatment.
measure: Changes in the Spinal cord independence measure (SCIM)
timeFrame: At 2 months, 6 months and 1 year after the injury
measure: Changes in the Montreal cognitive assessment (MoCA)
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the time to complete the bells cancellation test to assess cognitive impairments
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the number of omissions in the bells cancellation test to assess cognitive impairments
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
measure: Changes in the digit span test to assess cognitive impairments
timeFrame: Up to 1 month, then at 2 months and 1 year after the injury
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hospital
Study officials:
affiliation: APHP
name: Bernard VIGUE
role: PRINCIPAL_INVESTIGATOR
References: