Early Functional Proprioceptive Stimulation Post-stroke

Stroke (CVA) or TIA Clinical Trial

— StimProF  

Official title:

Early Functional Proprioceptive Stimulation Post-stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192953
• Other study ID #: 21-AOI-14
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Guillaume SACCO, MD
• Phone: 04 92 03 47 51
• Email: sacco.g[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke (CVA) or TIA

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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