Improving Postural Control Through Innovative Stimulation of the Proprioceptive System

NCT05367791 | Completed

• 2 other identifiers: 21CH1602021-A02416-35
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Every movement humans make in everyday life is based on a continuous integration of sensory information. A good interaction between sensory processes and motor control, called sensorimotor integration, is necessary for the efficiency of movements. Sensorimotor integration in the context of posture and walking is based on proprioception. Proprioception is the conscious and unconscious perception of the spatial and mechanical state of the musculoskeletal system. Proprioceptive information transmitted through the neuromuscular spindles in particular is suggested to play a role in motor rehabilitation.

Conditions

Sensorimotor Disorder

Keywords

Postural exercise; Localized vibration; Somatosensory electrical stimulation; Altered posture; Walking control

Outcome Measures

Primary Outcomes (1)

• Evaluation of body balance with the Berg Balance Scale (BBS)

  Variation of postural control

  Change from Week 8 to Week 16

Secondary Outcomes (10)

• Evaluation of body balance with the Berg Balance Scale (BBS)

  Change from Week 1 to Week 22

• Evaluation of the displacement of the center of pressure with force platform in centimeter

  Change from Week 1 to Week 22

• Displacement of the centrer of pressure with application of localized vibration in centimeter

  Change from Week 1 to Week 22

• Measure of the angular position error in degrees

  Change from Week 1 to Week 22

• Coefficient of variation muscle force control in percent

  Change from Week 1 to Week 22

Study Arms (4)

POSTUR

OTHER

Postural training only.

Other: POSTUR

POSTUR + LV (localized vibration)

OTHER

Postural training combined with localized vibration

Other: POSTUR; Other: Localised Vibration

POSTUR+SES (somatosensory electrical stimulation)

OTHER

Postural training combined with somatosensory electrical stimulation

Other: POSTUR; Other: Somatosensory Electrical Stimulation

POSTUR+LV-SES

OTHER

Postural training combined with somatosensory electrical stimulation and localized vibration

Other: POSTUR; Other: Localised Vibration; Other: Somatosensory Electrical Stimulation

Interventions

POSTUR OTHER

Training sessions without any stimulation

POSTUR; POSTUR + LV (localized vibration); POSTUR+LV-SES; POSTUR+SES (somatosensory electrical stimulation)

Localised Vibration OTHER

Training sessions with localized vibration

POSTUR + LV (localized vibration); POSTUR+LV-SES

Somatosensory Electrical Stimulation OTHER

Training sessions with somatosensory electrical stimulation

POSTUR+LV-SES; POSTUR+SES (somatosensory electrical stimulation)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Older Adults:
• Affiliated or beneficiaries of a social security plan
• Who have freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved
• Children with Cerebral Palsy:
• Children between the ages of 7 and 18 years, diagnosed with Spastic Cerebral Palsy, presenting with a clinical picture of infantile cerebral hemiplegia or diplegia.
• Children able to understand and follow the simple instructions of the examination
• Children walking GMFCS (Gross Motor Functional Classification system) I to II.
• Children with at least one parent and the child having given and signed the consent agreement
• Children who are members or beneficiaries of a social security system

You may not qualify if:

• Older adults:
• Pathology or surgery resulting in a locomotor disorder, within 6 months prior to the study,
• Chronic neurological, motor or psychological pathologies
• Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, anti-epileptics, psychotropic drugs, muscle relaxants) during the study.
• Contraindication to transcranial magnetic stimulation:
• Cardiac or respiratory insufficiency.
• Wearing a cardiac pace maker.
• Wearing a heart valve and severe cardiovascular diseases.
• Presence of prosthetic material or ferromagnetic foreign bodies in the head.
• Presence of cochlear implants or ocular prosthetic material.
• History of neurosurgical procedures.
• Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumor, multiple sclerosis, history of stroke or head injury).
• Participation at the same time in another interventional trial or having participated in a such a study within 30 days prior to this study.
• Obesity (body mass index ≥ 30.0 kg/m²)
• Children with cerebral palsy:

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Leonard Feasson, PHD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 10, 2022
• Study Start: June 29, 2022
• Primary Completion: February 7, 2024
• Study Completion: July 22, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)