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.
NCT04737018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2023-12-27
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.
Conditions
Interventions
- 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
- 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.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Saint Etienne
lead OTHER
Principal Investigators
-
Bruno FERNANDEZ, MD · CHU SAINT-ETIENNE
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-14
- Primary Completion
- 2023-09-29
- Completion
- 2023-12-15
Countries
- France
Study Locations
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