StrokeVIBRATACNCT04737018
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.
A study testing Fugl-Meyer Assessment (FMA), Medical Research Concil (MRC) and 2 Minute Walk Test (2MWT) in people with Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Fugl-Meyer Assessment (FMA), Medical Research Concil (MRC) and 2 Minute Walk Test (2MWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- 14 May 2021to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Multifocal stroke
- Patient having received a botulinum toxin injection to the lower limb to be vibrated
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
Le Clos Champirol - Service de Médecine Physique et de Réadaptation
Saint-Priest-en-Jarez
About this study
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
- Stroke
- Being tested
- Fugl-Meyer Assessment (FMA), Medical Research Concil (MRC), 2 Minute Walk Test (2MWT), Timed Up & Go Test, Modified Ashworth Scale
- Keywords
- muscle vibration protocol, anterior tibia muscle, hemiplegic patient
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fugl-Meyer Assessment (FMA)Other
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)Other
evaluation of muscular strength score from 0 to 5
2 Minute Walk Test (2MWT)Other
Assess functional walking and aerobic abilities
Timed Up & Go TestOther
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 ScaleOther
score from 0 to 4 evaluation of spasticity
Postural Assessment Scale for StrokeOther
score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position
posturographic recordingDevice
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
vibration programOther
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 programOther
a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| vibration program | Experimental | 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 Receives: Other: Fugl-Meyer Assessment (FMA); Other: Medical Research Concil (MRC); Other: 2 Minute Walk Test (2MWT); Other: Timed Up & Go Test; Other: Modified Ashworth Scale; Other: Postural Assessment Scale for Stroke; Device: posturographic recording; Other: vibration program |
| sham program | Sham comparator | a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. Receives: Other: Fugl-Meyer Assessment (FMA); Other: Medical Research Concil (MRC); Other: 2 Minute Walk Test (2MWT); Other: Timed Up & Go Test; Other: Modified Ashworth Scale; Other: Postural Assessment Scale for Stroke; Device: posturographic recording; Other: sham program |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of Fugl Meyer Assessment (lower limbs)
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
Measured: day 30
Secondary outcomes (6)
score of Fugl Meyer Assessment (lower limbs)
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
Measured: day 0, day 15, day 30 and month 2
score of Medical Research Concil
score of 0 (absence of contraction) to 5 (normal force)
Measured: day 0, day 15, day 30 and month 2
assess functional walking ability
measured with 2 Minute Walk Test
Measured: day 0, day 15, day 30 and month 2
score of postural assessment scale for stroke
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)
Measured: day 0, day 15, day 30 and month 2
analysis of static equilibrium
with Winposturo platform
Measured: day 0, day 15, day 30 and month 2
positional measurement of the center of gravity
with Winposturo platform
Measured: day 0, day 15, day 30 and month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start14 May 2021
- Primary completion29 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno FERNANDEZ, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737018
- Sponsor's protocol ID
- 20CH152
- Other IDs
- 2020-A03189-30
- Acronym
- VIBRATAC
- Status last verified
- Dec 2023
- First submitted
- 28 Jan 2021
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04737018
- Acronym / sponsor ID
- VIBRATAC / 20CH152
- Conditions
- Stroke
- Keywords
- muscle vibration protocol, anterior tibia muscle, hemiplegic patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vibration program | Experimental | Other: Fugl-Meyer Assessment (FMA), Other: Medical Research Concil (MRC), Other: 2 Minute Walk Test (2MWT), Other: Timed Up & Go Test, Other: Modified Ashworth Scale, Other: Postural Assessment Scale for Stroke, Device: posturographic recording, Other: vibration programa 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 | Sham comparator | Other: Fugl-Meyer Assessment (FMA), Other: Medical Research Concil (MRC), Other: 2 Minute Walk Test (2MWT), Other: Timed Up & Go Test, Other: Modified Ashworth Scale, Other: Postural Assessment Scale for Stroke, Device: posturographic recording, Other: sham programa 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Multifocal stroke
- Patient having received a botulinum toxin injection to the lower limb to be vibrated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | sham program, vibration program |
| Medical Research Concil (MRC)evaluation of muscular strength score from 0 to 5 | Other | sham program, vibration program |
| 2 Minute Walk Test (2MWT)Assess functional walking and aerobic abilities | Other | sham program, vibration program |
| Timed Up & Go Testmeasures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down | Other | sham program, vibration program |
| Modified Ashworth Scalescore from 0 to 4 evaluation of spasticity | Other | sham program, vibration program |
| Postural Assessment Scale for Strokescore from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position | Other | sham program, vibration program |
| posturographic recordinganalysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform | Device | sham program, vibration program |
| vibration programa 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 | vibration program |
| sham programa 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. | Other | sham program |
Primary outcome
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.
6 secondary outcomes
score of Fugl Meyer Assessment (lower limbs)
Time frame: 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
assess functional walking ability
Time frame: 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
analysis of static equilibrium
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
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Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno FERNANDEZ, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fugl-Meyer Assessment (FMA), Medical Research Concil (MRC) and 2 Minute Walk Test (2MWT) in people with Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of Fugl Meyer Assessment (lower limbs) (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.