Focal Muscle Vibrations in Acute Stroke

Not Applicable

Not yet recruiting

• Conditions: Acute Stroke

• Registration Number: NCT06793566
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

A prospective, randomized, double-blind, sham-controlled trial designed to evaluate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients treated within 72 hours of symptom onset

Detailed Description

After enrollment (T0), patients are randomly assigned to either the vibration group (VG) or the control group (CG). Patients in the VG will receive rMV treatment, while those in the CG receive sham treatment. Both interventions are administered on the 1st, 2nd, and 3rd days post-enrollment. Physiokinesitherapy (PT) and occupational therapy (OT) are provided daily to all patients, starting immediately after the T0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), marking the end of the treatment period.

Upon admission, demographic details and medical histories of all participants are recorded. Each patient undergoes clinical evaluations at all time points by an experienced investigator blinded to group allocation and distinct from the recruiting personnel. The clinical assessment includes stroke severity evaluation using the NIH Stroke Scale, motor and functional limb abilities using the Fugl-Meyer scale, SAFE score, and Motricity Index. Additionally, bioimpedance analysis of muscle mass and phase angle in the impaired upper limb is performed using the BWA device.

All participants follow a standardized daily rehabilitation program. Physical therapists, blinded to treatment allocation, are instructed on the duration, frequency, and content of therapy to ensure consistency across groups.

Low-amplitude rMV (frequency: 100 Hz; amplitude: 1-2 mm) is applied to the flexor carpi radialis and biceps brachii for upper limb treatment, using a commercial device (VibraMoov Physio, TechnoConcept, Mane, France). The rMV sessions are conducted over three consecutive days by two trained physiotherapists, with each daily session comprising three 10-minute treatments (per treated limb) interspersed with 1-minute breaks.

During the rMV sessions, participants are instructed to perform voluntary isometric contractions of the treated muscle. In contrast, CG participants undergo sham rMV, where the vibrator is positioned near the tendon but without vibration.

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Start: 2025-09
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Voluntary patients in the acute phase of a sylvian ischemic stroke (from day 1 to day 7 post-stroke)
2. Estimated hospital stay expected to exceed 7 days
3. Age ≥ 18 years
4. Able to understand and follow evaluation instructions
5. Provided informed consent
6. Affiliated with a social security scheme
7. SAFE score between 4 and 7 on the affected side

Exclusion Criteria

1. Individuals under guardianship or curatorship
2. Individuals deprived of liberty
3. Individuals under legal protection (safeguard of justice)
4. Other neurological or rheumatological conditions limiting mobility
5. Drowsiness (related to stroke or medication)
6. Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper limb Fugl Meyer Assessment Score (UL-FMA)	Day 4 from start of experiment	This is a 66-point scale. A score of 0 corresponds to the maximum deficit and a score of 66 to a normal value.

Secondary Outcome Measures

Name	Time	Method
Upper limb strength	Day 4 from start of experiment	A digital Jamar dynamometer is used to measure the flexion muscular strength of the deficient limb. The force value to be collected at each time point is the average of the 3 tests.Handgrip strength in kilograms
Motricity Index (Demeurisse)	Day 4 from start of experiment	It assesses the motor skills of the upper limb as a whole, with elementary movements (thumb-index pinch,elbow flexion, shoulder abduction). Scoring ranges from 0 - corresponding to no movement - to 33 - corresponding to movement with normal strength. The upper limb score is calculated by summing the score obtained for each of the 3 movements, adding 1 and dividing by 100.
SAFE Score	Day 4 from start of experiment	This is a 10 point scale. A score of 0 corresponds to no muscle contraction and a score of 10 to a normal muscular strength
Total NIHSS	Day 4 from start of experiment	A 15-item impairment rating scale designed to assess the neurological consequences and degree of recovery of a stroke patient.; Each item is rated from 0 to 2, 0 to 3 or 0 to 4. Each item that is non-testable is scored as "NT". A score of 0 indicates normal performance.; NIHSS total scores range from 0 to 42, with higher values reflecting more severe brain damage.
muscular mass of the impaired upper limb	Day 4 from start of experiment
Phase angle of the impaired upper limb	Day 4 from start of experiment

Trial Locations

Locations (1)

CHU d'ORLEANS; 🇫🇷 Orleans, France