Early Functional Proprioceptive Stimulation Post-stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Proprioceptive Stimulation.
- Who it may be relevant to
- Registry conditions: Stroke (CVA) or TIA. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The main objective of our study is to evaluate the impact of the use of Functional Proprioceptive Stimulation (FPS) on the recovery of the postural and motor functional capacities of the patient in the subacute phase of a stroke. The hypothesis is that the use of FPS has a positive impact on the recovery of the patient's functional abilities, as well as on the duration of treatment until the sit/stand transfers are completed. To evaluate this potential effect,there will be a randomization with two groups : one will have 5 sessions a week for 6 weeks maximum of SPF and the other groupe will have the same sessions but with the device stettled but not activated.
Interventions
- Other Functional Proprioceptive Stimulation
Orthoses with a system of 12 stimulators producing mechanical oscillations are attached to the joints of the upper limbs (wrist, elbow and shoulder) or lower limb joints (ankle, knee, hip). These stimulators, which are all synchronized, deliver mechanical oscillations (FPS) that give the illusion of complex movements, while the patient is bedridden, neither moving nor producing effort.
Primary outcome measures
- Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) [Time frame: Inclusion]
- Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) [Time frame: Every week during 5 weeks maximum]
- Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) [Time frame: 6 weeks]
- Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) [Time frame: 10 weeks]
Eligibility criteria
Inclusion criteria
- Adult patient hospitalized at Cimiez University Hospital;
- Ischemic or hemorrhagic cerebrovascular accident (CVA) of less than two weeks;
- Hemiparesis requiring rehabilitation treatment;
- Patient with a SFPASS score ≤ 6;
- Patient affiliated to or beneficiary of a social security scheme;
- Signature of informed consent
Exclusion criteria
- NIHSS > 20;
- Muscle spasticity of the lower limbs requiring botulinum toxin injection
- Inability to understand rehabilitation instructions;
- Vulnerable people
- Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than research,
- Adults who are subject to a legal protection measure or who are unable to express their consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT06192953 · 21-AOI-14