Early Functional Proprioceptive Stimulation Post-stroke

NCT ID: NCT06192953

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2025-04-30

Brief Summary

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.

Conditions

Stroke (CVA) or TIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulated group

5 sessions per week for 6 weeks maximum of reeducation with Functional Proprioceptive Stimulation

Group Type: EXPERIMENTAL

Functional Proprioceptive Stimulation

Intervention Type: OTHER

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.

Simulated group

5 sessions per week for 6 weeks maximum with the device of Functional Proprioceptive Stimulation settled but not activated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nice

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume SACCO, MD

Role: CONTACT

sacco.g@chu-nice.fr

04 92 03 47 51

Justine LEMAIRE

Role: CONTACT

lemaire.j@chu-nice.fr

+33492034778

Facility Contacts

Justine Lemaire

Role: primary

Other Identifiers

21-AOI-14

Identifier Type: -

Identifier Source: org_study_id