Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05315726

The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population

Led by Centre Hospitalier Universitaire Dijon · Updated on 2026-02-09

165

Participants Needed

2

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • Medically stable with no contraindications to stroke rehabilitation
  • Ischemic and/or hemorrhagic stroke more than 3 months ago affecting upper limb motor skills (Phase 1)
  • Modified Ashworth Scale between 1 and less than 4 on elbow or wrist flexors (Phase 1)
  • Provided oral consent (Phase 1)
  • Adult patient 18 years or older
  • Able to follow a rehabilitation program medically
  • First stroke within 6 weeks confirmed by imaging
  • Hemiparesis or hemiplegia of the upper limb with FMA-UE score less than 48, especially wrist and elbow flexors
  • Requires inpatient or outpatient rehabilitation
  • Provided oral consent (Phase 2)
Not Eligible

You will not qualify if you...

  • Significant pain on wrist or elbow movement exceeding 5 out of 10 on the pain scale
  • Other neurological, muscular, or bone/joint conditions affecting upper limb function
  • Open wounds or very fragile skin that may delay inclusion
  • Significant cognitive impairments preventing understanding or consent (LAST scores less than 5/7 in comprehension, or unreliable yes/no answers)
  • Not covered by national health insurance
  • Pregnant or breastfeeding
  • Under guardianship, curatorship, or legal protection measures

AI-Screening

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Trial Site Locations

Total: 2 locations

1

SSR Marguerite BOUCICAUT

Chalon-sur-Saône, France, 71100

Actively Recruiting

2

Chu Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

S

Sophie JULLIAND

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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