Post-stroke Patient in Acute, Sub-acute Phase or ChronicSPACE-TICNCT05315726
The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population
A study testing Dynamometer and Muscle vibrations in people with Post-stroke Patient in Acute, Sub-acute Phase or Chronic, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
Several studies have recently tested the use of muscle vibration for the rehabilitation of patients after a stroke. When applied in a repeated and focused manner, this vibration appears to promote the recovery of functional capacities through the mechanisms of neuromuscular plasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Patient in Acute, Sub-acute Phase or Chronic
- What is being tested?
- Dynamometer and Muscle vibrations
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jun 2022to Jul 2027
- 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
- Phase 1:
- Adult patient,
- Medically stable on medical assessment, with no contraindications to stroke rehabilitation management management (no medical problems or acute intercurrent medical events),
- Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the motor skills of the upper limbs,
- 1 ≤ MAS < 4 on elbow or wrist flexors,
- Having given oral consent.
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- Phase 2:
- Adult patient > 18 years old,
- Able to follow a rehabilitation program on medical opinion (no medical issues or acute intercurrent medical events),
- First stroke ever < 6 weeks, confirmed by imaging,
- Hemiparesis or hemiplegia of the upper limb (FMA-UE score < 48), particularly in the wrist and elbow flexors,
- Requiring inpatient or outpatient hospitalization in a rehabilitation center,
- Having given oral consent.
Who cannot join
- Phases 1 and 2:
- Significant pain on mobilization of the wrist or elbow (VAS > 5/10),
- Presence of other neurological, muscular or osteoarticular conditions altering upper limb function,
- Apparent wound, which may postpone inclusion, or very fragile skin,
- Significant cognitive impairments: inability to understand simple instructions or give consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if YES/NO answers are unreliable),
- Not covered by national health insurance,
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- Being pregnant or breastfeeding,
- Being under guardianship or curatorship.
- Person subject to a measure of legal protection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
SSR Marguerite BOUCICAUT
Chalon-sur-Saône, 71100
Marc-Antoine RAUMEL, 0385875252, Marc-antoine.raumel@croix-rouge.fr
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Sophie JULLIAND, 03.80.66.94.82, sophie.julliand@chu-dijon.fr
About this study
Official title: The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases): Randomized Controlled Trial
Several studies have recently tested the use of muscle vibration for the rehabilitation of patients after a stroke. When applied in a repeated and focused manner, this vibration appears to promote the recovery of functional capacities through the mechanisms of neuromuscular plasticity. These results are encouraging, showing in particular a significant decrease in spasticity in post-stroke patients in the chronic phase (> 6 months after stroke), on the upper and/or lower limbs. However, very few studies have been done on this type of early intervention. Muscle vibration may therefore be an innovative therapy to complement the care that is currently offered in the acute and subacute phase of post-stroke rehabilitation.
Moreover, brain plasticity after a stroke is particularly high in the 3 months after the accident, but the vast majority of studies having evaluated the impact of vibration in a chronic phase (> 12 months post-stroke). It is likely, however, that the influence of vibration, particularly on brain plasticity, is increased in the acute or subacute phase (first 6 months). To date, the effect of vibration on spinal cord or cortical plasticity has not been quantified in the acute or subacute phase. This is why the second part of this project (phase 2) aims to systematically evaluate and quantify the neuroplastic and functional effects of post-stroke vibration in the early phase.
Read more
Phase 1 - Validation of a method for measuring spasticity (upper limb) with an isokinetic dynamometer 32 patients with ischemic and/or hemorrhagic stroke (> 3 months after stroke)
Phase 2 - Use of this objective technique to measure the effect of a muscle vibration protocol to limit the onset of spasticity in a population of 100 patients following a stroke, in the acute or subacute phase (< 6 weeks post-stroke) in a randomized trial:
- intervention group: usual rehabilitation + muscle vibrations
- control group: usual rehabilitation + placebo vibrations
- Being tested
- Dynamometer, Muscle vibrations, Placebo muscle vibration
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamometerOther
Measurement of elbow/wrist spasticity
Muscle vibrationsOther
1 session of 10 minutes
Muscle vibrationsOther
3 times/week for 6 weeks
Placebo muscle vibrationOther
3 times/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Not described Receives: Other: Dynamometer; Other: Muscle vibrations |
| Phase 2: Intervention group | Experimental | Not described Receives: Other: Muscle vibrations |
| Phase 2: control group | Active comparator | Not described Receives: Other: Placebo muscle vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)
Joint angle (elbow or wrist of the limb contralateral to the brain injury) at the onset of a spastic contraction (maximum intensity of resistance to mobilization) recorded by isokinetic dynamometer on a wheelchair during the initial visit
Measured: at baseline
Phase 2: Scoring wrist flexor muscle spasticity
Scoring of wrist flexor muscle spasticity by the Modified Ashworth Scale (MAS), at the beginning of the study and at 6 weeks (end of intervention).
Measured: at 6 weeks
Secondary outcomes (22)
Sensorimotor function modifications of the paretic upper limb
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Measured: at 0, 6 weeks and 6 months
Sensorimotor function modifications of the paretic upper limb
Pain (Visual analog scale)
Measured: at 0, 6 weeks and 6 months
Sensorimotor function modifications of the paretic upper limb
tiredness (Visual analog scale)
Measured: at 0, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist
Angle of catch of spasticity measured by an isokinetic ergometer (in degree), only in Dijon
Measured: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist
Angle of end of spasticity measured by an isokinetic ergometer (in degree), only in Dijon
Measured: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist
Measured by an isokinetic ergometer : Torque developed during the spastic reaction that is determined by the angles of catch and end (in Newton per Meter (Nm)). It will be reported as a score difference in comparison to the reference curve: root mean square error (RMSE) only in Dijon
Measured: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow
Angle of catch of spasticity measured by an isokinetic ergometer (in degree), only in Dijon
Measured: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow
Angle of end of spasticity measured by an isokinetic ergometer (in degree), only in Dijon
Measured: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow
Measured by an isokinetic ergometer : Torque developed during the spastic reaction that is determined by the angles of catch and end (in Newton per Meter (Nm)). It will be reported as a score difference in comparison to the reference curve: root mean square error (RMSE) only in Dijon
Measured: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb (wrist and elbow)
Measured by the Modified Ashworth Scale (MAS)
Measured: at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis
at spinal level (H-reflex and M-wave), Only in Dijon.
Measured: at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis
at corticospinal level by transcranial magnetic stimulation (MEP and SICI), Only in Dijon.
Measured: at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis
at cortical level by electroencephalogram : The Delta, Theta, Alpha and Beta bands will be evaluated. ERD/ERS will be calculated during the resting states and the vibrations periods, principally over the C3-C4 electrodes (10-20 system).
Only in Dijon.
Measured: at 0, 3 weeks, 6 weeks and 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability
Tools: MAS scores (scale) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Tools: MAS scores (scale) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Tools: MAS scores (scale) and EEG ratio (ERD alpha and beta bands) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability
Tools: Angle of catch (in degree) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Tools: Angle of catch (in degree) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Tools: Angle of catch (in degree) and EEG ratio (ERD alpha and beta bands)) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability
Tools: Torque score (RMSE) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Tools: Torque score (RMSE) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon
Measured: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Tools: Torque score (RMSE) and EEG ratio (ERD alpha and beta bands)) Logistic regression Only in Dijon
Measured: Through study completion, on average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start14 Jun 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke Patient in Acute, Sub-acute Phase or ChronicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315726
- Sponsor's protocol ID
- JULLIAND AOIparaM 2021
- Acronym
- SPACE-TIC
- Status last verified
- Feb 2026
- First submitted
- 30 Mar 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team policy is about to share and collaborate with other research teams upon reasonable request for access to study data. Expressions of interest in access to study data, addressed to the corresponding author, will be considered and data de-identified at group or individual level may be shared as appropriate. A data transfer agreement will then be drawn up. The study dataset will be available at the end of the study, once the database is frozen. Sharing the database will be made available between interested parts with a data sharing agreement contract.
Publications
Julliand S, Papaxanthis C, Delphin C, Mock A, Raumel MA, Gueugnon M, Ornetti P, Laroche D. IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial. BMJ Open. 2024 Mar 15;14(3):e079918. doi: 10.1136/bmjopen-2023-079918.
PubMed 38490651
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05315726
- Acronym / sponsor ID
- SPACE-TIC / JULLIAND AOIparaM 2021
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Apr 2022 (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.
Several studies have recently tested the use of muscle vibration for the rehabilitation of patients after a stroke. When applied in a repeated and focused manner, this vibration appears to promote the recovery of functional capacities through the mechanisms of neuromuscular plasticity. These results are encouraging, showing in particular a significant decrease in spasticity in post-stroke patients in the chronic phase (> 6 months after stroke), on the upper and/or lower limbs. However, very few studies have been done on this type of early intervention. Muscle vibration may therefore be an innovative therapy to complement the care that is currently offered in the acute and subacute phase of post-stroke rehabilitation.
Moreover, brain plasticity after a stroke is particularly high in the 3 months after the accident, but the vast majority of studies having evaluated the impact of vibration in a chronic phase (> 12 months post-stroke). It is likely, however, that the influence of vibration, particularly on brain plasticity, is increased in the acute or subacute phase (first 6 months). To date, the effect of vibration on spinal cord or cortical plasticity has not been quantified in the acute or subacute phase. This is why the second part of this project (phase 2) aims to systematically evaluate and quantify the neuroplastic and functional effects of post-stroke vibration in the early phase.
Phase 1 - Validation of a method for measuring spasticity (upper limb) with an isokinetic dynamometer 32 patients with ischemic and/or hemorrhagic stroke (> 3 months after stroke)
Phase 2 - Use of this objective technique to measure the effect of a muscle vibration protocol to limit the onset of spasticity in a population of 100 patients following a stroke, in the acute or subacute phase (< 6 weeks post-stroke) in a randomized trial:
- intervention group: usual rehabilitation + muscle vibrations
- control group: usual rehabilitation + placebo vibrations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Other: Dynamometer, Other: Muscle vibrations |
| Phase 2: Intervention group | Experimental | Other: Muscle vibrations |
| Phase 2: control group | Active comparator | Other: Placebo muscle vibration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult patient,
- Medically stable on medical assessment, with no contraindications to stroke rehabilitation management management (no medical problems or acute intercurrent medical events),
- Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the motor skills of the upper limbs,
- 1 ≤ MAS < 4 on elbow or wrist flexors,
- Having given oral consent.
Key exclusion criteria (9 listed)
- Phases 1 and 2:
- Significant pain on mobilization of the wrist or elbow (VAS > 5/10),
- Presence of other neurological, muscular or osteoarticular conditions altering upper limb function,
- Apparent wound, which may postpone inclusion, or very fragile skin,
- Significant cognitive impairments: inability to understand simple instructions or give consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if YES/NO answers are unreliable),
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 |
|---|---|---|
| DynamometerMeasurement of elbow/wrist spasticity | Other | Phase 1 |
| Muscle vibrations1 session of 10 minutes | Other | Phase 1 |
| Muscle vibrations3 times/week for 6 weeks | Other | Phase 2: Intervention group |
| Placebo muscle vibration3 times/week for 6 weeks | Other | Phase 2: control group |
Primary outcome
Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)
Time frame: at baseline
Joint angle (elbow or wrist of the limb contralateral to the brain injury) at the onset of a spastic contraction (maximum intensity of resistance to mobilization) recorded by isokinetic dynamometer on a wheelchair during the initial visit
Phase 2: Scoring wrist flexor muscle spasticity
Time frame: at 6 weeks
Scoring of wrist flexor muscle spasticity by the Modified Ashworth Scale (MAS), at the beginning of the study and at 6 weeks (end of intervention).
22 secondary outcomes
Sensorimotor function modifications of the paretic upper limb
Time frame: at 0, 6 weeks and 6 months
Sensorimotor function modifications of the paretic upper limb
Time frame: at 0, 6 weeks and 6 months
Sensorimotor function modifications of the paretic upper limb
Time frame: at 0, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb (wrist and elbow)
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis
Time frame: at 0, 3 weeks, 6 weeks and 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Time frame: Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability
Time frame: Through study completion, on average of 6 months
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 9 Feb 2026.
- Derived from this study: PubMed 38490651Julliand S, Papaxanthis C, Delphin C, Mock A, Raumel MA, Gueugnon M, Ornetti P, Laroche D. IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial. BMJ Open. 2024 Mar 15;14(3):e079918. doi: 10.1136/bmjopen-2023-079918.
- Individual participant dataSharing planned: Yes. The study team policy is about to share and collaborate with other research teams upon reasonable request for access to study data. Expressions of interest in access to study data, addressed to the corresponding author, will be considered and data de-identified at group or individual level may be shared as appropriate. A data transfer agreement will then be drawn up. The study dataset will be available at the end of the study, once the database is frozen. Sharing the database will be made available between interested parts with a data sharing agreement contract.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamometer and Muscle vibrations in people with Post-stroke Patient in Acute, Sub-acute Phase or Chronic, run by Centre Hospitalier Universitaire Dijon 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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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. 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 Sophie JULLIAND (03.80.66.94.82, sophie.julliand@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury) (time frame: at baseline). The study lists 2 primary outcomes in all. 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 NCT05315726, which also lists 1 linked publication.
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 9 Feb 2026.