Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury (Tetra-Mouv)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: Proprioceptive stimulations; Device: Sham stimulations

Study type: Interventional

Funder types: Other

Identifiers

NCT05094752

2020-A02015-34

Details and patient eligibility

About

"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. "

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intervention group

Experimental group

Description:

Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the intervention group will receive proprioceptive stimulations set to create illusions of movement.

Treatment:

Device: Proprioceptive stimulations

Control group

Sham Comparator group

Description:

Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the control group will receive sham stimulations.

Treatment:

Device: Sham stimulations