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. (VIBRATAC)

December 26, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Centre Hospitalier Universitaire de Saint-Étienne
      • Saint-Priest-en-Jarez, France
        • Le Clos Champirol - Service de Médecine Physique et de Réadaptation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
score of Fugl Meyer Assessment (lower limbs)
Time Frame: day 30
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
score of Fugl Meyer Assessment (lower limbs)
Time Frame: 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.
day 0, day 15, day 30 and month 2
score of Medical Research Concil
Time Frame: day 0, day 15, day 30 and month 2
score of 0 (absence of contraction) to 5 (normal force)
day 0, day 15, day 30 and month 2
assess functional walking ability
Time Frame: day 0, day 15, day 30 and month 2
measured with 2 Minute Walk Test
day 0, day 15, day 30 and month 2
score of postural assessment scale for stroke
Time Frame: 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)
day 0, day 15, day 30 and month 2
analysis of static equilibrium
Time Frame: day 0, day 15, day 30 and month 2
with Winposturo platform
day 0, day 15, day 30 and month 2
positional measurement of the center of gravity
Time Frame: day 0, day 15, day 30 and month 2
with Winposturo platform
day 0, day 15, day 30 and month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno FERNANDEZ, MD, CHU Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20CH152
  • 2020-A03189-30 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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