Improving Postural Control Through Innovative Stimulation of the Proprioceptive System
NCT ID: NCT05367791
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2022-06-29
2024-07-22
Brief Summary
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Detailed Description
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In particular, this study will focus on the effects of these interventions on proprioception, postural control and walking in children with CP and older adults.Confirmation of hypotheses will open up new avenues for rehabilitation therapies and preventive interventions, and may be extended to other purposes and clinical populations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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POSTUR
Postural training only.
POSTUR
Training sessions without any stimulation
POSTUR + LV (localized vibration)
Postural training combined with localized vibration
POSTUR
Training sessions without any stimulation
Localised Vibration
Training sessions with localized vibration
POSTUR+SES (somatosensory electrical stimulation)
Postural training combined with somatosensory electrical stimulation
POSTUR
Training sessions without any stimulation
Somatosensory Electrical Stimulation
Training sessions with somatosensory electrical stimulation
POSTUR+LV-SES
Postural training combined with somatosensory electrical stimulation and localized vibration
POSTUR
Training sessions without any stimulation
Localised Vibration
Training sessions with localized vibration
Somatosensory Electrical Stimulation
Training sessions with somatosensory electrical stimulation
Interventions
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POSTUR
Training sessions without any stimulation
Localised Vibration
Training sessions with localized vibration
Somatosensory Electrical Stimulation
Training sessions with somatosensory electrical stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
* Children with concomitant muscle disease (e.g., myopathy...).
* Children who have received a baclofen injection in the 6 months preceding the evaluation.
* Children who have undergone neuro-orthopedic surgery on the lower limbs within the last 6 months
* Children who have received a botulinum toxin injection within the last 6 months
* Children participating in therapeutic programs other than their usual physical therapy sessions.
7 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Leonard Feasson, PHD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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Centre Hospitalier de Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2021-A02416-35
Identifier Type: OTHER
Identifier Source: secondary_id
21CH160
Identifier Type: -
Identifier Source: org_study_id
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