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Early Functional Proprioceptive Stimulation Post-stroke (StimProF)

C

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Stroke (CVA) or TIA

Treatments

Other: Functional Proprioceptive Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06192953
21-AOI-14

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Stimulated group
Experimental group
Description:
5 sessions per week for 6 weeks maximum of reeducation with Functional Proprioceptive Stimulation
Treatment:
Other: Functional Proprioceptive Stimulation
Simulated group
No Intervention group
Description:
5 sessions per week for 6 weeks maximum with the device of Functional Proprioceptive Stimulation settled but not activated

Trial contacts and locations

1

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Central trial contact

Justine LEMAIRE; Guillaume SACCO, MD

Data sourced from clinicaltrials.gov

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