Skip to content

Early Functional Proprioceptive Stimulation Post-stroke

Early Functional Proprioceptive Stimulation Post-stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06192953
Acronym
StimProF
Enrollment
32
Registered
2024-01-05
Start date
2024-05-06
Completion date
2027-04-30
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke (CVA) or TIA

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)InclusionThe 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.

Countries

France

Contacts

CONTACTGuillaume SACCO, MD
sacco.g@chu-nice.fr04 92 03 47 51
CONTACTJustine LEMAIRE
lemaire.j@chu-nice.fr+33492034778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026