NCT05315726: 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

Recruiting now NA Last updated 5 February 2026

What this trial tests

NA trial testing Dynamometer in Post-stroke Patient in Acute, Sub-acute Phase or Chronic in 165 participants. Currently enrolling.

Timeline

14 June 2022

Primary endpoint
1 July 2027

1 July 2027

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	165
Start date	14 June 2022
Primary completion	1 July 2027
Estimated completion	1 July 2027
Sites	2 locations across France

Drugs / interventions tested

• Dynamometer
• Muscle vibrations
• Muscle vibrations
• Placebo muscle vibration

Conditions studied

• Post-stroke Patient in Acute, Sub-acute Phase or Chronic — all drugs for Post-stroke Patient in Acute, Sub-acute Phase or Chronic →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Post-stroke Patient in Acute, Sub-acute Phase or Chronic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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).

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. IMPROVE study protocol, investigating post-stroke local muscle vibrations to promote cerebral plasticity and functional recovery: a single-blind randomised controlled trial.
   Julliand S, Papaxanthis C, Delphin C, Mock A, et al · · 2024 · cited 3× · PMID 38490651 · DOI 10.1136/bmjopen-2023-079918
2. Local muscle vibration in early subacute stroke: preliminary results on upper-limb spasticity and spinal excitability from the randomized placebo controlled IMPROVE study
   JULLIAND S, PAPAXANTHIS C, CUNNAC L, MOCK A, et al · · 2026 · DOI 10.21203/rs.3.rs-9310646/v1
3. Acute and chronic effects of local muscle vibration training inducing illusions on wrist strength and neurophysiological measures.
   Julliand S, Gaveau J, Martin A, Amiez N, et al · · 2025 · PMID 41315390 · DOI 10.1038/s41598-025-26915-z