Focal Muscle Vibrations in Acute Stroke (VIBRAMAIN2)

Centre Hospitalier Régional d'Orléans

Status: Begins enrollment in 3 months

Conditions: Acute Stroke

Treatments: Device: Repeated Muscle Vibration (rMV)

Study type: Interventional

Funder types: Other

Identifiers

NCT06793566

CHUO-2024-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Patients with Vibration

Experimental group

Description:

VG participants undergo rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle

Treatment:

Device: Repeated Muscle Vibration (rMV)

Control group (CG)

Sham Comparator group

Description:

Participants in the CG undergo sham rMV, where the vibrator is positioned near the tendon but does not produce vibrations. Sham rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle

Treatment:

Device: Repeated Muscle Vibration (rMV)