The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population
- Conditions
- Post-stroke Patient in Acute, Sub-acute Phase or Chronic
- Interventions
- Other: DynamometerOther: Placebo muscle vibrationOther: Muscle vibrations
- Registration Number
- NCT05315726
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- Brief 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. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 165
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.
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.
- 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,
- Being pregnant or breastfeeding,
- Being under guardianship or curatorship.
- Person subject to a measure of legal protection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1 Muscle vibrations - Phase 1 Dynamometer - Phase 2: Intervention group Muscle vibrations - Phase 2: control group Placebo muscle vibration -
- Primary Outcome Measures
Name Time Method Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury) 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 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).
- Secondary Outcome Measures
Name Time Method Correlation between the severity of spasticity at the wrist and the spinal excitability Through study completion, on average of 6 months Tools: Torque score (RMSE) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.
Spasticity of the paretic limb at the wrist at 0, 3 weeks, 6 weeks and 6 months 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
Spasticity of the paretic limb at the elbow at 0, 3 weeks, 6 weeks and 6 months 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
Spasticity of the paretic limb (wrist and elbow) at 0, 3 weeks, 6 weeks and 6 months Measured by the Modified Ashworth Scale (MAS)
Neuroplasticity modifications evaluated on the flexor carpi radialis at 0, 3 weeks, 6 weeks and 6 months 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.Sensorimotor function modifications of the paretic upper limb at 0, 6 weeks and 6 months tiredness (Visual analog scale)
Correlation between the severity of spasticity at the wrist and cortical excitability Through study completion, on average of 6 months Tools: Torque score (RMSE) and EEG ratio (ERD alpha and beta bands)) Logistic regression Only in Dijon
Trial Locations
- Locations (2)
Chu Dijon Bourgogne
🇫🇷Dijon, France
SSR Marguerite BOUCICAUT
🇫🇷Chalon-sur-Saône, France