Acute StrokeVIBRAMAIN2NCT06793566
Focal Muscle Vibrations in Acute Stroke
A study testing Repeated Muscle Vibration (rMV) in people with Acute Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
A prospective, randomized, double-blind, sham-controlled trial designed to evaluate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients treated within 72 hours of symptom onset Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Repeated Muscle Vibration (rMV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary patients in the acute phase of a sylvian ischemic stroke (from day 1 to day 7 post-stroke)
- Estimated hospital stay expected to exceed 7 days
- Age ≥ 18 years
- Able to understand and follow evaluation instructions
- Provided informed consent
- Affiliated with a social security scheme
- SAFE score between 4 and 7 on the affected side
Who cannot join
- Individuals under guardianship or curatorship
- Individuals deprived of liberty
- Individuals under legal protection (safeguard of justice)
- Other neurological or rheumatological conditions limiting mobility
- Drowsiness (related to stroke or medication)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tendon Vibrations on Motor Recovery of the Upper Limb in the Acute Phase of Stroke
A prospective, randomized, double-blind, sham-controlled trial designed to evaluate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients treated within 72 hours of symptom onset
Read the detailed description
After enrollment (T0), patients are randomly assigned to either the vibration group (VG) or the control group (CG). Patients in the VG will receive rMV treatment, while those in the CG receive sham treatment. Both interventions are administered on the 1st, 2nd, and 3rd days post-enrollment. Physiokinesitherapy (PT) and occupational therapy (OT) are provided daily to all patients, starting immediately after the T0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), marking the end of the treatment period.
Upon admission, demographic details and medical histories of all participants are recorded. Each patient undergoes clinical evaluations at all time points by an experienced investigator blinded to group allocation and distinct from the recruiting personnel. The clinical assessment includes stroke severity evaluation using the NIH Stroke Scale, motor and functional limb abilities using the Fugl-Meyer scale, SAFE score, and Motricity Index. Additionally, bioimpedance analysis of muscle mass and phase angle in the impaired upper limb is performed using the BWA device.
All participants follow a standardized daily rehabilitation program. Physical therapists, blinded to treatment allocation, are instructed on the duration, frequency, and content of therapy to ensure consistency across groups.
Low-amplitude rMV (frequency: 100 Hz; amplitude: 1-2 mm) is applied to the flexor carpi radialis and biceps brachii for upper limb treatment, using a commercial device (VibraMoov Physio, TechnoConcept, Mane, France). The rMV sessions are conducted over three consecutive days by two trained physiotherapists, with each daily session comprising three 10-minute treatments (per treated limb) interspersed with 1-minute breaks.
During the rMV sessions, participants are instructed to perform voluntary isometric contractions of the treated muscle. In contrast, CG participants undergo sham rMV, where the vibrator is positioned near the tendon but without vibration.
- Conditions
- Acute Stroke
- Being tested
- Repeated Muscle Vibration (rMV)
- Keywords
- Acute stroke, Repetitive tendinous vibrations, Motor recovery, Non pharmacological therapy, Bedside intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated Muscle Vibration (rMV)Device
rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle
| Study group | Role | What they receive |
|---|---|---|
| Patients with Vibration | Experimental | VG participants undergo rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle Receives: Device: Repeated Muscle Vibration (rMV) |
| Control group (CG) | Sham comparator | Participants in the CG undergo sham rMV, where the vibrator is positioned near the tendon but does not produce vibrations. Sham rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle Receives: Device: Repeated Muscle Vibration (rMV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb Fugl Meyer Assessment Score (UL-FMA)
This is a 66-point scale. A score of 0 corresponds to the maximum deficit and a score of 66 to a normal value.
Measured: Day 4 from start of experiment
Secondary outcomes (6)
Upper limb strength
A digital Jamar dynamometer is used to measure the flexion muscular strength of the deficient limb. The force value to be collected at each time point is the average of the 3 tests.Handgrip strength in kilograms
Measured: Day 4 from start of experiment
Motricity Index (Demeurisse)
It assesses the motor skills of the upper limb as a whole, with elementary movements (thumb-index pinch,elbow flexion, shoulder abduction). Scoring ranges from 0 - corresponding to no movement - to 33 - corresponding to movement with normal strength. The upper limb score is calculated by summing the score obtained for each of the 3 movements, adding 1 and dividing by 100.
Measured: Day 4 from start of experiment
SAFE Score
This is a 10 point scale. A score of 0 corresponds to no muscle contraction and a score of 10 to a normal muscular strength
Measured: Day 4 from start of experiment
Total NIHSS
A 15-item impairment rating scale designed to assess the neurological consequences and degree of recovery of a stroke patient.
Each item is rated from 0 to 2, 0 to 3 or 0 to 4. Each item that is non-testable is scored as "NT". A score of 0 indicates normal performance.
NIHSS total scores range from 0 to 42, with higher values reflecting more severe brain damage.
Measured: Day 4 from start of experiment
muscular mass of the impaired upper limb
Measured: Day 4 from start of experiment
Phase angle of the impaired upper limb
Measured: Day 4 from start of experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: Reorganisation and difficulties of neurology service of CHU Orleans
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 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, Principal investigator, CHU Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793566
- Sponsor's protocol ID
- CHUO-2024-13
- Acronym
- VIBRAMAIN2
- Status last verified
- Jul 2025
- First submitted
- 21 Jan 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9.
PubMed 26206167Bobos 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 31730754Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
PubMed 22507444Celletti 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 28240760Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6.
PubMed 27598342Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
PubMed 7439211Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Toscano 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 30873102Abe T, Yoshimura Y, Imai R, Yoneoka Y, Tsubaki A, Sato Y. Impact of Phase Angle on Physical Function in Patients with Acute Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105941. doi: 10.1016/j.jstrokecerebrovasdis.2021.105941. Epub 2021 Jun 30.
PubMed 34217068Abe T, Yoshimua Y, Imai R, Sato Y. A Combined Assessment Method of Phase Angle and Skeletal Muscle Index to Better Predict Functional Recovery after Acute Stroke. J Nutr Health Aging. 2022;26(5):445-451. doi: 10.1007/s12603-022-1777-9.
PubMed 35587756
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tendon Vibrations on Motor Recovery of the Upper Limb in the Acute Phase of Stroke
- ClinicalTrials.gov ID
- NCT06793566
- Acronym / sponsor ID
- VIBRAMAIN2 / CHUO-2024-13
- Conditions
- Acute Stroke
- Keywords
- Acute stroke, Repetitive tendinous vibrations, Motor recovery, Non pharmacological therapy, Bedside intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reorganisation and difficulties of neurology service of CHU Orleans
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Jan 2025 (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.
A prospective, randomized, double-blind, sham-controlled trial designed to evaluate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients treated within 72 hours of symptom onset
Detailed description
After enrollment (T0), patients are randomly assigned to either the vibration group (VG) or the control group (CG). Patients in the VG will receive rMV treatment, while those in the CG receive sham treatment. Both interventions are administered on the 1st, 2nd, and 3rd days post-enrollment. Physiokinesitherapy (PT) and occupational therapy (OT) are provided daily to all patients, starting immediately after the T0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), marking the end of the treatment period.
Upon admission, demographic details and medical histories of all participants are recorded. Each patient undergoes clinical evaluations at all time points by an experienced investigator blinded to group allocation and distinct from the recruiting personnel. The clinical assessment includes stroke severity evaluation using the NIH Stroke Scale, motor and functional limb abilities using the Fugl-Meyer scale, SAFE score, and Motricity Index. Additionally, bioimpedance analysis of muscle mass and phase angle in the impaired upper limb is performed using the BWA device.
All participants follow a standardized daily rehabilitation program. Physical therapists, blinded to treatment allocation, are instructed on the duration, frequency, and content of therapy to ensure consistency across groups.
Low-amplitude rMV (frequency: 100 Hz; amplitude: 1-2 mm) is applied to the flexor carpi radialis and biceps brachii for upper limb treatment, using a commercial device (VibraMoov Physio, TechnoConcept, Mane, France). The rMV sessions are conducted over three consecutive days by two trained physiotherapists, with each daily session comprising three 10-minute treatments (per treated limb) interspersed with 1-minute breaks.
During the rMV sessions, participants are instructed to perform voluntary isometric contractions of the treated muscle. In contrast, CG participants undergo sham rMV, where the vibrator is positioned near the tendon but without vibration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Vibration | Experimental | Device: Repeated Muscle Vibration (rMV)VG participants undergo rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle |
| Control group (CG) | Sham comparator | Device: Repeated Muscle Vibration (rMV)Participants in the CG undergo sham rMV, where the vibrator is positioned near the tendon but does not produce vibrations. Sham rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary patients in the acute phase of a sylvian ischemic stroke (from day 1 to day 7 post-stroke)
- Estimated hospital stay expected to exceed 7 days
- Age ≥ 18 years
- Able to understand and follow evaluation instructions
- Provided informed consent
Key exclusion criteria (6 listed)
- Individuals under guardianship or curatorship
- Individuals deprived of liberty
- Individuals under legal protection (safeguard of justice)
- Other neurological or rheumatological conditions limiting mobility
- Drowsiness (related to stroke or medication)
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 |
|---|---|---|
| Repeated Muscle Vibration (rMV)rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle | Device | Control group (CG), Patients with Vibration |
Primary outcome
Upper limb Fugl Meyer Assessment Score (UL-FMA)
Time frame: Day 4 from start of experiment
This is a 66-point scale. A score of 0 corresponds to the maximum deficit and a score of 66 to a normal value.
6 secondary outcomes
Upper limb strength
Time frame: Day 4 from start of experiment
Motricity Index (Demeurisse)
Time frame: Day 4 from start of experiment
SAFE Score
Time frame: Day 4 from start of experiment
Total NIHSS
Time frame: Day 4 from start of experiment
muscular mass of the impaired upper limb
Time frame: Day 4 from start of experiment
Phase angle of the impaired upper limb
Time frame: Day 4 from start of experiment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 26206167Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9.
- 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.
- Background: PubMed 22507444Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
- 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 27598342Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6.
- Background: PubMed 7439211Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- 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 34217068Abe T, Yoshimura Y, Imai R, Yoneoka Y, Tsubaki A, Sato Y. Impact of Phase Angle on Physical Function in Patients with Acute Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105941. doi: 10.1016/j.jstrokecerebrovasdis.2021.105941. Epub 2021 Jun 30.
- Background: PubMed 35587756Abe T, Yoshimua Y, Imai R, Sato Y. A Combined Assessment Method of Phase Angle and Skeletal Muscle Index to Better Predict Functional Recovery after Acute Stroke. J Nutr Health Aging. 2022;26(5):445-451. doi: 10.1007/s12603-022-1777-9.
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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 principal investigator
CHU Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated Muscle Vibration (rMV) in people with Acute Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site 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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Upper limb Fugl Meyer Assessment Score (UL-FMA) (time frame: Day 4 from start of experiment). 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 NCT06793566, which also lists 10 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 10 Jul 2025.