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

NCT05094752 | Unknown

• 1 other identifier: 2020-A02015-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. "

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuries; quadriplegia; proprioceptive stimulation; vibration; spasticity; intensive care units

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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 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.

• 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 nitrogen balance,

  Every 48 hours during the first two weeks, and then once a week for six weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

Proprioceptive stimulations DEVICE

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.

Intervention group

Sham stimulations DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Related Publications (1)

• Martinache F, de Crouy AC, Boutin A, Duranteau J, Vigue B. Early functional proprioceptive stimulation in high spinal cord injury: a pilot study. Front Rehabil Sci. 2025 Feb 26;6:1490904. doi: 10.3389/fresc.2025.1490904. eCollection 2025.

  PMID: 40078600 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Bernard VIGUE

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 26, 2021
• Study Start: October 20, 2021
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 26, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)