VIBRATAC: 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.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: vibration program 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 |
Other: Fugl-Meyer Assessment (FMA)
assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34
Other: Medical Research Concil (MRC)
evaluation of muscular strength score from 0 to 5
Other: 2 Minute Walk Test (2MWT)
Assess functional walking and aerobic abilities
Other: Timed Up & Go Test
measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down
Other: Modified Ashworth Scale
score from 0 to 4 evaluation of spasticity
Other: Postural Assessment Scale for Stroke
score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position
Device: posturographic recording
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
Other: vibration program
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
|
| Sham Comparator: sham program a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. |
Other: Fugl-Meyer Assessment (FMA)
assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34
Other: Medical Research Concil (MRC)
evaluation of muscular strength score from 0 to 5
Other: 2 Minute Walk Test (2MWT)
Assess functional walking and aerobic abilities
Other: Timed Up & Go Test
measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down
Other: Modified Ashworth Scale
score from 0 to 4 evaluation of spasticity
Other: Postural Assessment Scale for Stroke
score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position
Device: posturographic recording
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
Other: sham program
a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.
|
Outcome Measures
Primary Outcome Measures
- score of Fugl Meyer Assessment (lower limbs) [day 30]
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
Secondary Outcome Measures
- score of Fugl Meyer Assessment (lower limbs) [day 0, day 15, day 30 and month 2]
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
- score of Medical Research Concil [day 0, day 15, day 30 and month 2]
score of 0 (absence of contraction) to 5 (normal force)
- assess functional walking ability [day 0, day 15, day 30 and month 2]
measured with 2 Minute Walk Test
- score of postural assessment scale for stroke [day 0, day 15, day 30 and month 2]
measures the patient's ability to maintain stable postures, as well as balance in changes of position score of 0 (cannot perform the activity) to 36 (can perform the activity)
- analysis of static equilibrium [day 0, day 15, day 30 and month 2]
with Winposturo platform
- positional measurement of the center of gravity [day 0, day 15, day 30 and month 2]
with Winposturo platform
Eligibility Criteria
Criteria
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.
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No neurological history other than stroke.
Exclusion Criteria:
-
Multifocal stroke
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Patient having received a botulinum toxin injection to the lower limb to be vibrated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Saint-Etienne | Saint-Etienne | France | 42055 | |
| 2 | Le Clos Champirol - Service de Médecine Physique et de Réadaptation | Saint-Priest-en-Jarez | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
Investigators
- Principal Investigator: Bruno FERNANDEZ, MD, CHU Saint Etienne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20CH152
- 2020-A03189-30