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

Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury : a Randomized Controlled Trial

"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. "

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Proprioceptive stimulations; Device: Sham stimulations

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Bicetre Hospital
    • Contact: Bernard Vigué, MD PhD; Phone Number: 0033145216310; Email: bernard.vigue@aphp.fr
    • Principal Investigator: Bernard Vigué, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Device: Proprioceptive stimulations; 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.
Sham Comparator: Control group; 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.	Device: Sham stimulations; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the modified Ashworth scale (MAS)	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)	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 angles of the muscle reaction in the modified Tardieu scale (MTS)	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)	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 quality of the muscle reaction in the modified Tardieu scale (MTS)	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)	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 Spinal cord assessment tool for spastic reflexes (SCATS)	This score enables to asses global spasticity (Score range from 0 to 18, higher values represent a higher degree of spasticity)	Every week during the eight weeks of treatment, then at 2 months (end of treatment), 6 months and 1 year after the injury.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the visual analog scale for the auto-assessment of problematic spasticity	Score range from 0 to 100, higher values represent a higher degree 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 visual analog scale for the auto-assessment of pain	Score range from 0 to 100, higher values represent a higher intensity 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	This score enables to assess sensorimotor recovery (Score range from 0 to 324, higher values represent a better outcome)	At inclusion, and at one week, one month, 2 months, 6 months and 1 year after the injury.
Changes in the quadriceps muscle thickness	"Measured with ultrasound, average of two measures (at the border between the lower third and upper two-thirds between the anterior superior iliac spine and the upper pole of the patella, and at the midpoint between the anterior superior iliac spine and the upper pole of the patella) (Measure in centimeters, higher values represent a better outcome)"	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 nitrogen balance,	Marker of protein losses (Measure in mmol/L, lower values represent a better outcome)	Every 48 hours during the first two weeks, and then once a week for six weeks
Number of days between the SCI and the verticalization at 45°	The attempt is successful if the position is maintained for 5 minutes without adverse effect. The verticalization protocol will remain the same as the one commonly used in the ICU. According to this protocol, verticalization will be progressive and mean blood pressure will be monitored continuously. The attempt is stopped if the patient feels unwell (signs of intolerance) or if the mean blood pressure drops by more than 20% (Measure in days, higher values represent a lower outcome)	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°	The attempt is successful if the position is maintained for 5 minutes without adverse effect. The verticalization protocol will remain the same as the one commonly used in the ICU. According to this protocol, verticalization will be progressive and mean blood pressure will be monitored continuously. The attempt is stopped if the patient feels unwell (signs of intolerance) or if the mean blood pressure drops by more than 20% (Measure in days, higher values represent a lower outcome)	Verticalization is attempted progressively 3 times a week during the 8 weeks of treatment.
Changes in the Spinal cord independence measure (SCIM)	This measure enables to assess functional status (Score range from 0 to 100, higher values represent a better outcome)	At 2 months, 6 months and 1 year after the injury
Changes in the Montreal cognitive assessment (MoCA)	This measure enables to assess cognitive impairments (Score range from 0 to 30, higher values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury
Changes in the time to complete the bells cancellation test to assess cognitive impairments	This measure enables to assess cognitive impairments (Measure in minutes and seconds, lower values represent a better outcome)	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	This measure enables to assess cognitive impairments (Lower values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury
Changes in the digit span test to assess cognitive impairments	This measure enables to assess cognitive impairments (Higher values represent a better outcome)	Up to 1 month, then at 2 months and 1 year after the injury

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Bernard VIGUE, APHP

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2021
• Primary Completion (Anticipated): September 20, 2024
• Study Completion (Anticipated): September 20, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: spinal cord injuries; spasticity; quadriplegia; intensive care units; vibration; proprioceptive stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2020-A02015-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No