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.
NCT ID: NCT04737018
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2021-05-14
2023-12-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
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
Medical Research Concil (MRC)
evaluation of muscular strength score from 0 to 5
2 Minute Walk Test (2MWT)
Assess functional walking and aerobic abilities
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
Modified Ashworth Scale
score from 0 to 4 evaluation of spasticity
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
posturographic recording
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
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 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.
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
Medical Research Concil (MRC)
evaluation of muscular strength score from 0 to 5
2 Minute Walk Test (2MWT)
Assess functional walking and aerobic abilities
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
Modified Ashworth Scale
score from 0 to 4 evaluation of spasticity
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
posturographic recording
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
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.
Interventions
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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
Medical Research Concil (MRC)
evaluation of muscular strength score from 0 to 5
2 Minute Walk Test (2MWT)
Assess functional walking and aerobic abilities
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
Modified Ashworth Scale
score from 0 to 4 evaluation of spasticity
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
posturographic recording
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
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 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.
Eligibility Criteria
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Inclusion Criteria
* Responsible for a motor deficit in the right or left lower limb.
* No neurological history other than stroke.
Exclusion Criteria
* Patient having received a botulinum toxin injection to the lower limb to be vibrated
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Bruno FERNANDEZ, MD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, , France
Le Clos Champirol - Service de Médecine Physique et de Réadaptation
Saint-Priest-en-Jarez, , France
Countries
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Other Identifiers
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2020-A03189-30
Identifier Type: OTHER
Identifier Source: secondary_id
20CH152
Identifier Type: -
Identifier Source: org_study_id