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NCT Number: NCT05315726

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

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

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Key information

Conditions

Post-stroke Patient in Acute, Sub-acute Phase or Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SSR Marguerite BOUCICAUT, Chalon-sur-Saône, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamometer

Other

Measurement of elbow/wrist spasticity

Muscle vibrations

Other

1 session of 10 minutes

Placebo muscle vibration

Other

3 times/week for 6 weeks

Primary outcomes

  1. Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)

    Time frame: 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

  2. Phase 2: Scoring wrist flexor muscle spasticity

    Time frame: 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 outcomes

  1. Sensorimotor function modifications of the paretic upper limb

    Time frame: at 0, 6 weeks and 6 months

    Fugl-Meyer Assessment of Upper Extremity (FMA-UE)

  2. Sensorimotor function modifications of the paretic upper limb

    Time frame: at 0, 6 weeks and 6 months

    Pain (Visual analog scale)

  3. Sensorimotor function modifications of the paretic upper limb

    Time frame: at 0, 6 weeks and 6 months

    tiredness (Visual analog scale)

  4. Spasticity of the paretic limb at the wrist

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    Angle of catch of spasticity measured by an isokinetic ergometer (in degree), only in Dijon

  5. Spasticity of the paretic limb at the wrist

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    Angle of end of spasticity measured by an isokinetic ergometer (in degree), only in Dijon

  6. Spasticity of the paretic limb at the wrist

    Time frame: 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

  7. Spasticity of the paretic limb at the elbow

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    Angle of catch of spasticity measured by an isokinetic ergometer (in degree), only in Dijon

  8. Spasticity of the paretic limb at the elbow

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    Angle of end of spasticity measured by an isokinetic ergometer (in degree), only in Dijon

  9. Spasticity of the paretic limb at the elbow

    Time frame: 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

  10. Spasticity of the paretic limb (wrist and elbow)

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    Measured by the Modified Ashworth Scale (MAS)

  11. Neuroplasticity modifications evaluated on the flexor carpi radialis

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    at spinal level (H-reflex and M-wave), Only in Dijon.

  12. Neuroplasticity modifications evaluated on the flexor carpi radialis

    Time frame: at 0, 3 weeks, 6 weeks and 6 months

    at corticospinal level by transcranial magnetic stimulation (MEP and SICI), Only in Dijon.

  13. Neuroplasticity modifications evaluated on the flexor carpi radialis

    Time frame: 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.

  14. Correlation between the severity of spasticity at the wrist and the spinal excitability

    Time frame: Through study completion, on average of 6 months

    Tools: MAS scores (scale) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.

  15. Correlation between the severity of spasticity at the wrist and cortical excitability

    Time frame: Through study completion, on average of 6 months

    Tools: MAS scores (scale) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon.

  16. Correlation between the severity of spasticity at the wrist and cortical excitability

    Time frame: Through study completion, on average of 6 months

    Tools: MAS scores (scale) and EEG ratio (ERD alpha and beta bands) Logistic regression Only in Dijon.

  17. Correlation between the severity of spasticity at the wrist and the spinal excitability

    Time frame: Through study completion, on average of 6 months

    Tools: Angle of catch (in degree) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.

  18. Correlation between the severity of spasticity at the wrist and cortical excitability

    Time frame: Through study completion, on average of 6 months

    Tools: Angle of catch (in degree) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon.

  19. Correlation between the severity of spasticity at the wrist and cortical excitability

    Time frame: Through study completion, on average of 6 months

    Tools: Angle of catch (in degree) and EEG ratio (ERD alpha and beta bands)) Logistic regression Only in Dijon.

  20. Correlation between the severity of spasticity at the wrist and the spinal excitability

    Time frame: 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.

  21. Correlation between the severity of spasticity at the wrist and cortical excitability

    Time frame: Through study completion, on average of 6 months

    Tools: Torque score (RMSE) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon

  22. Correlation between the severity of spasticity at the wrist and cortical excitability

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie JULLIAND

CONTACT

[email protected]

03.80.66.94.82

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: SPACE-TIC

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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