Ireland
--:--IST
Recruiting Not applicable

Early Functional Proprioceptive Stimulation Post-stroke

NCT06192953 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-05-06
Last updated
2026-03-27

Condition(s) studied

Stroke (CVA) or TIA

Investigational drug(s) / intervention(s)

Functional Proprioceptive Stimulation

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) — Inclusion
    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.
  • Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) — Every week during 5 weeks maximum
    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.
  • Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) — 6 weeks
    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.
  • Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS) — 10 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
CHU de Nice Nice France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06192953 on ClinicalTrials.gov ↗ ← All trials in France