Clinical trial NCT05315726: The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-stroke Patient in Acute, Sub-acute Phase or Chronic
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)
timeFrame: at baseline
measure: Phase 2: Scoring wrist flexor muscle spasticity
timeFrame: at 6 weeks
Secondary outcomes:
measure: Sensorimotor function modifications of the paretic upper limb
timeFrame: at 0, 6 weeks and 6 months
measure: Sensorimotor function modifications of the paretic upper limb
timeFrame: at 0, 6 weeks and 6 months
measure: Sensorimotor function modifications of the paretic upper limb
timeFrame: at 0, 6 weeks and 6 months
measure: Spasticity of the paretic limb at the wrist
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Spasticity of the paretic limb at the wrist
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Spasticity of the paretic limb at the wrist
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Spasticity of the paretic limb at the elbow
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Spasticity of the paretic limb at the elbow
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Spasticity of the paretic limb at the elbow
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Spasticity of the paretic limb (wrist and elbow)
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Neuroplasticity modifications evaluated on the flexor carpi radialis
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Neuroplasticity modifications evaluated on the flexor carpi radialis
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Neuroplasticity modifications evaluated on the flexor carpi radialis
timeFrame: at 0, 3 weeks, 6 weeks and 6 months
measure: Correlation between the severity of spasticity at the wrist and the spinal excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and cortical excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and cortical excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and the spinal excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and cortical excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and cortical excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and the spinal excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and cortical excitability
timeFrame: Through study completion, on average of 6 months
measure: Correlation between the severity of spasticity at the wrist and cortical excitability
timeFrame: Through study completion, on average of 6 months
Other outcomes:
Locations:
city: Chalon-sur-Saône
country: France
facility: SSR Marguerite BOUCICAUT
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: