Early Functional Proprioceptive Stimulation Post-stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

NIHSS > 20;

Muscle spasticity of the lower limbs requiring botulinum toxin injection

Inability to understand rehabilitation instructions;

Vulnerable people

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional Proprioceptive Stimulation

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Stimulated groupExperimental treatment 1 intervention
Group B: Simulated groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Inclusion
2

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.

Time frame
Every week during 5 weeks maximum
3

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.

Time frame
6 weeks
4

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.

Time frame
10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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