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NCT Number: NCT06192953

Early Functional Proprioceptive Stimulation Post-stroke

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.

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Key information

Conditions

Stroke (CVA) or TIA Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France

Location status: Recruiting

Location contact

Guillaume SACCO

PRINCIPAL_INVESTIGATOR

Justine Lemaire

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume SACCO, MD

CONTACT

[email protected]

04 92 03 47 51

Justine LEMAIRE

CONTACT

[email protected]

+33492034778

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: StimProF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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