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

The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases): Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Post-stroke Patient in Acute, Sub-acute Phase or Chronic
• Intervention / Treatment: Other: Dynamometer; Other: Muscle vibrations; Other: Muscle vibrations; Other: Placebo muscle vibration

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie JULLIAND; Phone Number: 03.80.66.94.82; Email: sophie.julliand@chu-dijon.fr

Study Locations

• France
  • Chalon-sur-Saône, France, 71100
    • Recruiting
    • SSR Marguerite BOUCICAUT
    • Contact: Marc-Antoine RAUMEL; Phone Number: 0385875252; Email: Marc-antoine.raumel@croix-rouge.fr
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Sophie JULLIAND; Phone Number: 03.80.66.94.82; Email: sophie.julliand@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2: Intervention group	Other: Muscle vibrations; 1 session of 10 minutes; Other: Muscle vibrations; 3 times/week for 6 weeks
Active Comparator: Phase 2: control group	Other: Placebo muscle vibration; 3 times/week for 6 weeks
Experimental: Phase 1	Other: Dynamometer; Measurement of elbow/wrist spasticity; Other: Muscle vibrations; 1 session of 10 minutes; Other: Muscle vibrations; 3 times/week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensorimotor function modifications of the paretic upper limb	Fugl-Meyer Assessment of Upper Extremity (FMA-UE)	at 0, 6 weeks and 6 months
Sensorimotor function modifications of the paretic upper limb	Pain (Visual analog scale)	at 0, 6 weeks and 6 months
Sensorimotor function modifications of the paretic upper limb	tiredness (Visual analog scale)	at 0, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist	Angle of catch of spasticity measured by an isokinetic ergometer (in degree), only in Dijon	at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist	Angle of end of spasticity measured by an isokinetic ergometer (in degree), only in Dijon	at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the wrist	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	at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow	Angle of catch of spasticity measured by an isokinetic ergometer (in degree), only in Dijon	at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow	Angle of end of spasticity measured by an isokinetic ergometer (in degree), only in Dijon	at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb at the elbow	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	at 0, 3 weeks, 6 weeks and 6 months
Spasticity of the paretic limb (wrist and elbow)	Measured by the Modified Ashworth Scale (MAS)	at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis	at spinal level (H-reflex and M-wave), Only in Dijon.	at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis	at corticospinal level by transcranial magnetic stimulation (MEP and SICI), Only in Dijon.	at 0, 3 weeks, 6 weeks and 6 months
Neuroplasticity modifications evaluated on the flexor carpi radialis	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.	at 0, 3 weeks, 6 weeks and 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability	Tools: MAS scores (scale) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability	Tools: MAS scores (scale) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability	Tools: MAS scores (scale) and EEG ratio (ERD alpha and beta bands) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability	Tools: Angle of catch (in degree) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability	Tools: Angle of catch (in degree) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability	Tools: Angle of catch (in degree) and EEG ratio (ERD alpha and beta bands)) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and the spinal excitability	Tools: Torque score (RMSE) and the amplitude of the H-reflex (in Volt) Logistic regression Only in Dijon.	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability	Tools: Torque score (RMSE) and EEG ratio (laterality coefficient) Logistic regression Only in Dijon	Through study completion, on average of 6 months
Correlation between the severity of spasticity at the wrist and cortical excitability	Tools: Torque score (RMSE) and EEG ratio (ERD alpha and beta bands)) Logistic regression Only in Dijon	Through study completion, on average of 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: JULLIAND AOIparaM 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team policy is about to share and collaborate with other research teams upon reasonable request for access to study data. Expressions of interest in access to study data, addressed to the corresponding author, will be considered and data de-identified at group or individual level may be shared as appropriate. A data transfer agreement will then be drawn up. The study dataset will be available at the end of the study, once the database is frozen. Sharing the database will be made available between interested parts with a data sharing agreement contract.
• IPD Sharing Time Frame: after publication of the lead article
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No