Using muscle vibration to improve recovery after a stroke

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

This study tests whether using muscle vibrations can help people recovering from a stroke feel better and regain movement more effectively.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (other)
• Locations: 2 sites (Chalon-sur-Saône and 1 other locations)
• Trial ID: NCT05315726 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of muscle vibration therapy on spasticity and neuroplasticity in post-stroke patients during the acute and sub-acute phases of recovery. By applying targeted muscle vibrations, the study aims to enhance functional recovery and reduce spasticity in patients who have experienced a stroke. The intervention includes the use of a dynamometer to deliver muscle vibrations, with a comparison to placebo vibrations. The study seeks to determine the effectiveness of this innovative approach in promoting rehabilitation outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults who have experienced their first stroke within the last six weeks and have upper limb hemiparesis or hemiplegia.

Not a fit: Patients with significant pain during mobilization or those with other neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve recovery outcomes and quality of life for post-stroke patients.

How similar studies have performed: While previous studies have shown promise for muscle vibration in chronic stroke rehabilitation, this approach in the acute and sub-acute phases is relatively novel.

Eligibility criteria

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

Where this trial is running

Chalon-sur-Saône and 1 other locations

• SSR Marguerite BOUCICAUT — Chalon-sur-Saône, France (RECRUITING)
• Chu Dijon Bourgogne — Dijon, France (RECRUITING)

Study contacts

• Study coordinator: Sophie JULLIAND

Conditions: Post-stroke Patient in Acute, Sub-acute Phase or Chronic