Early Functional Proprioceptive Stimulation Post-stroke (StimProF)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke (CVA) or TIA
• Intervention / Treatment: Other: Functional Proprioceptive Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine LEMAIRE; Phone Number: +33492034778; Email: lemaire.j@chu-nice.fr
• Study Contact Backup: Name: Guillaume SACCO, MD; Phone Number: 04 92 03 47 51; Email: sacco.g@chu-nice.fr

Study Locations

• France
  • Nice, France
    • Recruiting
    • CHU de Nice
    • Principal Investigator: Guillaume SACCO
    • Contact: Justine Lemaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulated group; 5 sessions per week for 6 weeks maximum of reeducation with Functional Proprioceptive Stimulation	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.
No Intervention: Simulated group; 5 sessions per week for 6 weeks maximum with the device of Functional Proprioceptive Stimulation settled but not activated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 21-AOI-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No