Acute StrokeVIBRASTROKENCT07905625
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
A study testing TVS rehabilitation sessions in people with Acute Stroke and Upper Limb Motor Deficit, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Strokes often induce a motor deficit. The resulting immobilization is in itself an aggravation factor since it worsens the motor deficit induced by the stroke itself. Amongst the different sensory stimulations, the use of tendon vibratory stimulations (TVS) that activate proprioceptive pathways (muscle spindle fibers)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Upper Limb Motor Deficit
- What is being tested?
- TVS rehabilitation sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2026to 3 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Person (or trusted/related person for aphasic patients with understanding impairment) that accepted to participate in the study.
- Aged ≥ 18-year-old
- Patient in acute stroke stage (from D1 to D6 post-stroke)
- Estimated hospitalization stay longer than 8 days.
- Able to understand and execute simple evaluation instructions (ex: " raise the arm ")
- SAFE score between 0 and 7 on the affected side.
Who cannot join
- Other neurological or rheumatological pathology that limit mobility.
- Somnolence (linked to the stroke or iatrogenic)
- Bilateral stroke with bilateral motor deficit.
- Protected person (under tutelage or guardianship)
- Person under legal protection
- Person deprived of liberty
- Person not affiliated to a social security system
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Universitaire d'Orléans
Orléans, Loiret, 45067
Mathilde SARRAZIN, 0238744665 ext. +33, mathilde.sarrazin@chu-orleans.fr
About this study
Strokes often induce a motor deficit. The resulting immobilization is in itself an aggravation factor since it worsens the motor deficit induced by the stroke itself.
Amongst the different sensory stimulations, the use of tendon vibratory stimulations (TVS) that activate proprioceptive pathways (muscle spindle fibers) is gaining increasing interest in the rehabilitation world.
Read more
Tendon vibratory stimulation (TVS) can be used on patients with little to no voluntary motor functions. Therefore, it seems particularly suited to significant upper limb deficits, and especially as early as possible after a stroke occurs when motor skills are severely affected.
Various studies have shown the interest of using vibratory stimulations in the management of post-stroke motor disorders. The majority were conducted in the chronic stroke stage. Only one small scale study has been conducted on the acute stroke stage.
Read the detailed description
For patients with upper limb function deficit in acute stroke stage, is studied the effect of added tendon vibratory stimulation (TVS) to the usual rehabilitation sessions.
The vibratory stimulation equipment is Vibramoov physio (Techno Concept) 54 patients will be randomized in two groups, stratified on SAFE score and age:
- Control group: Usual rehabilitation session The usual rehabilitation session implies: passive or active mobilization, stretching, video therapy, robot therapy.
- Experimental group: Tendon vibratory stimulation (TVS) technique (30min) added before the usual rehabilitation session For the TVS technique: two stimulators will be placed on the distal part of the forearm: the first on the anterior side the second on the posterior side. The patient will receive 3 sets of 10 min stimulation spaced 1min apart. The stimulation frequency is 100 Hz, the amplitude is 2 mm. 10 rehabilitation sessions will occur within a period between 10 and 25 days after inclusion. 3 different time slots are defined for evaluations: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions T3: After 10 rehabilitation session or when the patient leaves (if before 10 sessions with a minimum of 8)
Will be evaluated in the two groups at T1, T2 and T3:
- Fugl Meyer Assessment (FMA)
- Shoulder Abduction and Finger Extension score (SAFE)
- Grip strength (with a Jamar dynamometer)
- Thumb Localization Test (TLT)
- Erasmus modified Nottingham Assessment (EmNSA)
- Modified Ashworth Scale (MAS)
- Numeric Pain Rating Scale (NPRS)
- Conditions
- Acute Stroke, Upper Limb Motor Deficit
- Being tested
- TVS rehabilitation sessions
- Keywords
- physical therapy, acute stroke, tendon vibratory stimulation, motor skill recovery, upper limb function deficit
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVS rehabilitation sessionsProcedure or surgery
Patients randomized in the experimental group will have Tendon vibratory stimulation (TVS) technique (30min) added before their usual rehabilitation session
Two stimulators will be placed on the distal part of the forearm: the first on the anterior side the second on the posterior side. The patient will receive 3 sets of 10 min stimulation spaced 1min apart. The stimulation frequency is 100 Hz, the amplitude is 2 mm.
| Study group | Role | What they receive |
|---|---|---|
| Tendon vibratory stimulation group | Experimental | Patients randomized in the experimental group will have Tendon vibratory stimulation (TVS) technique (30min) added before their usual rehabilitation session (30min). Receives: Procedure: TVS rehabilitation sessions |
| Control group | No intervention | Patients randomized in the control group will have the usual rehabilitation session (30min). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study whether adding tendon vibratory stimulation (TVS) to the usual rehabilitation sessions on the after upper limb after a stroke improves the recovery of the limb's motor strength.
Fugl Meyer Assesment (FMA) of the affected limb after 5 rehabilitation session (T2) with or without the TVS. FMA score ranges from 0 to 66, with 0 representing the most severe deficit and 66 representing normal motor function.
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days)
Secondary outcomes (6)
Study the effect of adding TVS rehabilitation on the motor strength of the affected upper limb over time.
Motor strength of the affected upper limb scored by Shoulder Abduction and Finger Extension (SAFE) Score. The SAFE score is calculated by summing the MRC grades for shoulder abduction and finger extension. The total score ranges from 0 to 10, where 0 represents no voluntary muscle activity in shoulder abduction and finger extension and 10 represents normal strength in both movement.
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study the effect of adding TVS rehabilitation on wrist motor strength over time.
Motor strength of the wrist (on the affected upper limb) is evaluated by subsection n°6 of the Fugl Meyer Assesment (FMA). Score ranges from 0 (severe impairment) to 6 (normal coordination and speed)
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study the effect of adding TVS rehabilitation on finger grip strength over time.
Grip strength evaluated with a Jamar dynamometer (the value retained being the average of 3 tries).
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding TVS rehabilitation improves the conscious deep sensitivity of the affected upper limb over time
Conscious deep sensitivity of the affected upper limb is evaluated by Thumb Localization Test (TLT). TLT ranges from 0 to 3, where 0 indicates normal thumb localization and 3 indicates severe proprioceptive impairment with inability to accurately locate the thumb.
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding STV therapy reduces spasticity in the affected upper limb over time.
Spasticity is evaluated by modified Ashworth scale. This scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding STV therapy reduces pain in the affected upper limb over time
Pain in the affected upper limb is evaluated by Visual Analogue Scale (VAS). The VAS ranges from 0 to 10. 0 represents the worst pain and 10 represents no pain.
Measured: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start3 Nov 2026 (estimated)
- Primary completion3 Dec 2028 (estimated)
- Study completion3 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Prospective, controlled, randomized, single-blind study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde SARRAZIN, Principal investigator, Centre Hospitalier Universitaire d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905625
- Sponsor's protocol ID
- CHUO-2026-05
- Acronym
- VIBRASTROKE
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
- ClinicalTrials.gov ID
- NCT07905625
- Acronym / sponsor ID
- VIBRASTROKE / CHUO-2026-05
- Conditions
- Acute Stroke, Upper Limb Motor Deficit
- Keywords
- physical therapy, acute stroke, tendon vibratory stimulation, motor skill recovery, upper limb function deficit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 3 Dec 2028 (estimated)
- Study completion
- 3 Dec 2028 (estimated)
- First posted
- 29 Oct 2026 (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.
Strokes often induce a motor deficit. The resulting immobilization is in itself an aggravation factor since it worsens the motor deficit induced by the stroke itself.
Amongst the different sensory stimulations, the use of tendon vibratory stimulations (TVS) that activate proprioceptive pathways (muscle spindle fibers) is gaining increasing interest in the rehabilitation world.
Tendon vibratory stimulation (TVS) can be used on patients with little to no voluntary motor functions. Therefore, it seems particularly suited to significant upper limb deficits, and especially as early as possible after a stroke occurs when motor skills are severely affected.
Various studies have shown the interest of using vibratory stimulations in the management of post-stroke motor disorders. The majority were conducted in the chronic stroke stage. Only one small scale study has been conducted on the acute stroke stage.
Detailed description
For patients with upper limb function deficit in acute stroke stage, is studied the effect of added tendon vibratory stimulation (TVS) to the usual rehabilitation sessions.
The vibratory stimulation equipment is Vibramoov physio (Techno Concept) 54 patients will be randomized in two groups, stratified on SAFE score and age:
- Control group: Usual rehabilitation session The usual rehabilitation session implies: passive or active mobilization, stretching, video therapy, robot therapy.
- Experimental group: Tendon vibratory stimulation (TVS) technique (30min) added before the usual rehabilitation session For the TVS technique: two stimulators will be placed on the distal part of the forearm: the first on the anterior side the second on the posterior side. The patient will receive 3 sets of 10 min stimulation spaced 1min apart. The stimulation frequency is 100 Hz, the amplitude is 2 mm. 10 rehabilitation sessions will occur within a period between 10 and 25 days after inclusion. 3 different time slots are defined for evaluations: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions T3: After 10 rehabilitation session or when the patient leaves (if before 10 sessions with a minimum of 8)
Will be evaluated in the two groups at T1, T2 and T3:
- Fugl Meyer Assessment (FMA)
- Shoulder Abduction and Finger Extension score (SAFE)
- Grip strength (with a Jamar dynamometer)
- Thumb Localization Test (TLT)
- Erasmus modified Nottingham Assessment (EmNSA)
- Modified Ashworth Scale (MAS)
- Numeric Pain Rating Scale (NPRS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, controlled, randomized, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Tendon vibratory stimulation group | Experimental | Procedure: TVS rehabilitation sessionsPatients randomized in the experimental group will have Tendon vibratory stimulation (TVS) technique (30min) added before their usual rehabilitation session (30min). |
| Control group | No intervention | –Patients randomized in the control group will have the usual rehabilitation session (30min). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Person (or trusted/related person for aphasic patients with understanding impairment) that accepted to participate in the study.
- Aged ≥ 18-year-old
- Patient in acute stroke stage (from D1 to D6 post-stroke)
- Estimated hospitalization stay longer than 8 days.
- Able to understand and execute simple evaluation instructions (ex: " raise the arm ")
Key exclusion criteria (8 listed)
- Other neurological or rheumatological pathology that limit mobility.
- Somnolence (linked to the stroke or iatrogenic)
- Bilateral stroke with bilateral motor deficit.
- Protected person (under tutelage or guardianship)
- Person under legal protection
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 |
|---|---|---|
| TVS rehabilitation sessionsPatients randomized in the experimental group will have Tendon vibratory stimulation (TVS) technique (30min) added before their usual rehabilitation session Two stimulators will be placed on the distal part of the forearm: the first on the anterior side the second on the posterior side. The patient will receive 3 sets of 10 min stimulation spaced 1min apart. The stimulation frequency is 100 Hz, the amplitude is 2 mm. | Procedure or surgery | Tendon vibratory stimulation group |
Primary outcome
Study whether adding tendon vibratory stimulation (TVS) to the usual rehabilitation sessions on the after upper limb after a stroke improves the recovery of the limb's motor strength.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days)
Fugl Meyer Assesment (FMA) of the affected limb after 5 rehabilitation session (T2) with or without the TVS. FMA score ranges from 0 to 66, with 0 representing the most severe deficit and 66 representing normal motor function.
6 secondary outcomes
Study the effect of adding TVS rehabilitation on the motor strength of the affected upper limb over time.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study the effect of adding TVS rehabilitation on wrist motor strength over time.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study the effect of adding TVS rehabilitation on finger grip strength over time.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding TVS rehabilitation improves the conscious deep sensitivity of the affected upper limb over time
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding STV therapy reduces spasticity in the affected upper limb over time.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding STV therapy reduces pain in the affected upper limb over time
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mathilde SARRAZIN principal investigator
Centre Hospitalier Universitaire d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVS rehabilitation sessions in people with Acute Stroke and Upper Limb Motor Deficit, 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Sarrazin (0238744665 ext. +33, mathilde.sarrazin@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study whether adding tendon vibratory stimulation (TVS) to the usual rehabilitation sessions on the after upper limb after a stroke improves the recovery of the limb's motor strength. (time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days)). 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 29 Oct 2026.