Status:
RECRUITING
The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Post-stroke Patient in Acute, Sub-acute Phase or Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05315726
Start Date
June 14 2022
End Date
January 1 2026
Last Update
May 20 2025
Active Locations (2)
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1
SSR Marguerite BOUCICAUT
Chalon-sur-Saône, France, 71100
2
Chu Dijon Bourgogne
Dijon, France, 21000