Early Functional Proprioceptive Stimulation Post-stroke

NCT06192953 | Recruiting

• 1 other identifier: 21-AOI-14
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

  The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

  Inclusion

• Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

  The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

  Every week during 5 weeks maximum

• Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

  The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

  6 weeks

• Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

  The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

  10 weeks

Study Arms (2)

Stimulated group

EXPERIMENTAL

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

Other: Functional Proprioceptive Stimulation

Simulated group

NO INTERVENTION

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

Interventions

Functional Proprioceptive Stimulation 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.

Stimulated group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Guillaume SACCO, MD

CONTACT

04 92 03 47 51; sacco.g@chu-nice.fr

Justine LEMAIRE

CONTACT

+33492034778; lemaire.j@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 5, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)