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

NCT05315726 | Recruiting

• 1 other identifier: JULLIAND AOIparaM 2021
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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

Conditions

Post-stroke Patient in Acute, Sub-acute Phase or Chronic

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (22)

• Sensorimotor function modifications of the paretic upper limb

  at 0, 6 weeks and 6 months

• Sensorimotor function modifications of the paretic upper limb

  at 0, 6 weeks and 6 months

• Sensorimotor function modifications of the paretic upper limb

  at 0, 6 weeks and 6 months

• Spasticity of the paretic limb at the wrist

  at 0, 3 weeks, 6 weeks and 6 months

• Spasticity of the paretic limb at the wrist

  at 0, 3 weeks, 6 weeks and 6 months

Study Arms (3)

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

Interventions

Dynamometer OTHER

Measurement of elbow/wrist spasticity

Phase 1

Muscle vibrations OTHER

1 session of 10 minutes

Phase 1

Placebo muscle vibration OTHER

3 times/week for 6 weeks

Phase 2: control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• ≤ 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.

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

SSR Marguerite BOUCICAUT

Chalon-sur-Saône, 71100, France

RECRUITING

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 38490651 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Muscle Strength Dynamometer

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Central Study Contacts

Sophie JULLIAND

CONTACT

03.80.66.94.82; sophie.julliand@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: June 14, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: after publication of the lead article

Locations

FR (2)