StrokeVIBRAMAIN1NCT06296225
Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase
A study testing Vibration in people with Stroke and Stroke, Acute, run by Centre Hospitalier Régional d'Orléans at 4 sites in France.
Trial summary
It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Stroke, Acute, Fatigue
- What is being tested?
- Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Mar 2024to 20 Aug 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18 to 85
- Acute stroke (less than 7 days)
- Paretic upper limb: 3 or 4 to the MRC score and able to obtain a value of at least 10 kilograms on the handgrip strength
- Able to sign a consent form
- Affiliated to a social insurance
Who cannot join
- Person under tutorship or curatorship,
- Sleepiness
- Pregnancy or breastfeeding woman
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH de Chartres
Chartres
CHU d'ORLEANS
Orléans, 45067
Hopital Pitie Salpetriere
Paris
CHU de Tours
Tours
About this study
Official title: Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase : Vibramain1
It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.
The investigations will be carried out by a specialized physiotherapist from the neurology department.
Read more
The experiment consists of three successive phases:
- First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.
- Second : Rest period
- Third: control phase with measurement of the maximum grip force every ten minutes without vibration.
- Conditions
- Stroke, Stroke, Acute, Fatigue
- Being tested
- Vibration
- Keywords
- Stroke, vibration, Handgrip strength, Fatigue
- Medical subject headings
- Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrationDevice
Also called Handgrip Strength
Grip strenght measurement will always be done in the same way : for each series, 3 measurements of maximum strength will be taken for each side. Participants will receive verbal encouragement.
After initial both sides grip strength evaluation, all participant will first experiment the vibration situation using the device Vibramoov Physio (TechnoConcept, Manosque, France): the vibrations had a frequency of 100Hz, with an amplitude of 2mm, they will be applied to the anterior part of the forearm for 10 minutes, 3 times. At the end of each 10 minutes vibration session, handgrip strength will be assessed.
- Participants then have a one-hour rest period.
- Control situation: participants will have 4 series of grip strength measurements every 10 minutes.
At the end of the 2 hours, the patient will be discharged from the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Vibration group | Experimental | Patients with acute stroke less than 7 days with only one paretic upper limb will be assessed for eligibility.
Patient will undergo 8 grip strength evaluation and 30 minutes of forehand muscles vibration. Receives: Device: Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum handgrip strength measured by a digital dynamometer
Handgrip strength in kilograms
Measured: 2 hours
Secondary outcomes (2)
Fatigue evolution
Fatigue assessed with Borg Scale : Minimal score indicates no fatigue (Minimum : 0 - Maximum : 10)
Measured: 2 hours
Evolution of handgrip strength during the vibration session measured by a digital dynamometer
Handgrip strength in kilograms
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start5 Mar 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan OZSANCAK, MD, Study chair, CHU ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296225
- Sponsor's protocol ID
- CHRO-2023-07
- Acronym
- VIBRAMAIN1
- Status last verified
- Oct 2024
- First submitted
- 12 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Souron R, Besson T, Millet GY, Lapole T. Correction to: Acute and chronic neuromuscular adaptations to local vibration training. Eur J Appl Physiol. 2018 Feb;118(2):483. doi: 10.1007/s00421-017-3776-9.
PubMed 29218406Shirato R, Shimanuki R, Shoji T, Mugikura M. Inhibitory Effects of Prolonged Focal Muscle Vibration on Maximal Grip Strength and Muscle Activity of Wrist and Extrinsic Finger Flexor Muscles. J Chiropr Med. 2023 Jun;22(2):107-115. doi: 10.1016/j.jcm.2023.03.003. Epub 2023 Apr 21.
PubMed 37346243Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019.
PubMed 30873102Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979.
PubMed 28240760Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
PubMed 31730754
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase : Vibramain1
- ClinicalTrials.gov ID
- NCT06296225
- Acronym / sponsor ID
- VIBRAMAIN1 / CHRO-2023-07
- Conditions
- Stroke, Stroke, Acute, Fatigue
- Keywords
- Stroke, vibration, Handgrip strength, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 6 Mar 2024 (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.
It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.
The investigations will be carried out by a specialized physiotherapist from the neurology department.
The experiment consists of three successive phases:
- First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.
- Second : Rest period
- Third: control phase with measurement of the maximum grip force every ten minutes without vibration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibration group | Experimental | Device: VibrationPatients with acute stroke less than 7 days with only one paretic upper limb will be assessed for eligibility. Patient will undergo 8 grip strength evaluation and 30 minutes of forehand muscles vibration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age:18 to 85
- Acute stroke (less than 7 days)
- Paretic upper limb: 3 or 4 to the MRC score and able to obtain a value of at least 10 kilograms on the handgrip strength
- Able to sign a consent form
- Affiliated to a social insurance
Key exclusion criteria (3 listed)
- Person under tutorship or curatorship,
- Sleepiness
- Pregnancy or breastfeeding woman
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 |
|---|---|---|
| VibrationAlso: Handgrip StrengthGrip strenght measurement will always be done in the same way : for each series, 3 measurements of maximum strength will be taken for each side. Participants will receive verbal encouragement. After initial both sides grip strength evaluation, all participant will first experiment the vibration situation using the device Vibramoov Physio (TechnoConcept, Manosque, France): the vibrations had a frequency of 100Hz, with an amplitude of 2mm, they will be applied to the anterior part of the forearm for 10 minutes, 3 times. At the end of each 10 minutes vibration session, handgrip strength will be assessed. * Participants then have a one-hour rest period. * Control situation: participants will have 4 series of grip strength measurements every 10 minutes. At the end of the 2 hours, the patient will be discharged from the study protocol. | Device | Vibration group |
Primary outcome
Maximum handgrip strength measured by a digital dynamometer
Time frame: 2 hours
Handgrip strength in kilograms
2 secondary outcomes
Fatigue evolution
Time frame: 2 hours
Evolution of handgrip strength during the vibration session measured by a digital dynamometer
Time frame: 30 minutes
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 15 Oct 2024.
- Background: PubMed 29218406Souron R, Besson T, Millet GY, Lapole T. Correction to: Acute and chronic neuromuscular adaptations to local vibration training. Eur J Appl Physiol. 2018 Feb;118(2):483. doi: 10.1007/s00421-017-3776-9.
- Background: PubMed 37346243Shirato R, Shimanuki R, Shoji T, Mugikura M. Inhibitory Effects of Prolonged Focal Muscle Vibration on Maximal Grip Strength and Muscle Activity of Wrist and Extrinsic Finger Flexor Muscles. J Chiropr Med. 2023 Jun;22(2):107-115. doi: 10.1016/j.jcm.2023.03.003. Epub 2023 Apr 21.
- Background: PubMed 30873102Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019.
- Background: PubMed 28240760Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979.
- Background: PubMed 31730754Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
- Individual participant dataSharing planned: No
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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.
Canan OZSANCAK, MD study chair
CHU ORLEANS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration in people with Stroke and Stroke, Acute, run by Centre Hospitalier Régional d'Orléans at 4 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 5 inclusion and 3 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
Maximum handgrip strength measured by a digital dynamometer (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296225, which also lists 5 linked publications.
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 15 Oct 2024.