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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737018 on ClinicalTrials.gov