Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients. (VIBRATAC)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Stroke

Treatments: Device: posturographic recording; Other: sham program; Other: Postural Assessment Scale for Stroke; Other: Medical Research Concil (MRC); Other: Modified Ashworth Scale; Other: Fugl-Meyer Assessment (FMA); Other: vibration program; Other: 2 Minute Walk Test (2MWT); Other: Timed Up & Go Test

Study type: Interventional

Funder types: Other

Identifiers

NCT04737018

2020-A03189-30 (Other Identifier)

20CH152

Details and patient eligibility

About

In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).
• Responsible for a motor deficit in the right or left lower limb.
• No neurological history other than stroke.

Exclusion criteria

• Multifocal stroke
• Patient having received a botulinum toxin injection to the lower limb to be vibrated

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

vibration program

Experimental group

Description:

a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm

Treatment:

Other: Timed Up & Go Test

Other: 2 Minute Walk Test (2MWT)

Other: Modified Ashworth Scale

Other: Fugl-Meyer Assessment (FMA)

Other: vibration program

Device: posturographic recording

Other: Medical Research Concil (MRC)

Other: Postural Assessment Scale for Stroke

sham program

Sham Comparator group

Description:

a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.

Treatment:

Other: Timed Up & Go Test

Other: 2 Minute Walk Test (2MWT)

Other: Modified Ashworth Scale

Other: Fugl-Meyer Assessment (FMA)

Device: posturographic recording

Other: Medical Research Concil (MRC)

Other: Postural Assessment Scale for Stroke

Other: sham program