Informations générales (source: ClinicalTrials.gov)
The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (acute and Subacute Phases): Randomized Controlled Trial (SPACE-TIC)
Interventional
N/A
Centre Hospitalier Universitaire Dijon (Voir sur ClinicalTrials)
juin 2022
janvier 2026
05 avril 2025
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
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Chu Dijon Bourgogne - 21000 - Dijon - France | Sophie JULLIAND | Contact (sur clinicalTrials) | |||
| SSR Marguerite BOUCICAUT - 71100 - Chalon-sur-Saône - France | Marc-Antoine RAUMEL | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
- 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