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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.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04737018
Acronym
VIBRATAC
Enrollment
38
Registered
2021-02-03
Start date
2021-05-14
Completion date
2023-12-15
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

muscle vibration protocol, anterior tibia muscle, hemiplegic patient

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.

Interventions

OTHERFugl-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

OTHERMedical Research Concil (MRC)

evaluation of muscular strength score from 0 to 5

Assess functional walking and aerobic abilities

OTHERTimed 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

score from 0 to 4 evaluation of spasticity

OTHERPostural Assessment Scale for Stroke

score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position

DEVICEposturographic recording

analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform

OTHERvibration 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

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

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
score of Fugl Meyer Assessment (lower limbs)day 30score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.

Secondary

MeasureTime frameDescription
score of Fugl Meyer Assessment (lower limbs)day 0, day 15, day 30 and month 2score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
score of Medical Research Concilday 0, day 15, day 30 and month 2score of 0 (absence of contraction) to 5 (normal force)
assess functional walking abilityday 0, day 15, day 30 and month 2measured with 2 Minute Walk Test
score of postural assessment scale for strokeday 0, day 15, day 30 and month 2measures 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 equilibriumday 0, day 15, day 30 and month 2with Winposturo platform
positional measurement of the center of gravityday 0, day 15, day 30 and month 2with Winposturo platform

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026