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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Experimental |
| |
| Phase 2: Intervention group | Experimental |
| |
| Phase 2: control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamometer | Other | Measurement of elbow/wrist spasticity |
| |
| Muscle vibrations |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sensorimotor function modifications of the paretic upper limb | Fugl-Meyer Assessment of Upper Extremity (FMA-UE) | at 0, 6 weeks and 6 months |
| Sensorimotor function modifications of the paretic upper limb |
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Inclusion Criteria:
Phase 1:
Phase 2:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie JULLIAND | Contact | 03.80.66.94.82 | sophie.julliand@chu-dijon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSR Marguerite BOUCICAUT | Recruiting | Chalon-sur-Saône | 71100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38490651 | Derived | 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. |
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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.
after publication of the lead article
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| Other |
1 session of 10 minutes |
|
| Muscle vibrations | Other | 3 times/week for 6 weeks |
|
| Placebo muscle vibration | Other | 3 times/week for 6 weeks |
|
Pain (Visual analog scale)
| at 0, 6 weeks and 6 months |
| Sensorimotor function modifications of the paretic upper limb | tiredness (Visual analog scale) | 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 | 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 | 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 | 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 | 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 | 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 | at 0, 3 weeks, 6 weeks and 6 months |
| Spasticity of the paretic limb (wrist and elbow) | Measured by the Modified Ashworth Scale (MAS) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | Through study completion, on average of 6 months |
| Chu Dijon Bourgogne | Recruiting | Dijon | 21000 | France |
|
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D053581 | Muscle Strength Dynamometer |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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