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

NCT ID: NCT05094752

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2024-09-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Proprioceptive stimulations

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham stimulations

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard VIGUE

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Bernard Vigué, MD PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40078600 (View on PubMed)

Other Identifiers

2020-A02015-34

Identifier Type: -

Identifier Source: org_study_id