Focal Muscle Vibrations in Acute Stroke (VIBRAMAIN2)

July 7, 2025 updated by: Centre Hospitalier Régional d'Orléans

Effect of Tendon Vibrations on Motor Recovery of the Upper Limb in the Acute Phase of Stroke

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orleans, France, 45067
        • CHU d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group (CG)
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
Device: Repeated Muscle Vibration (rMV)
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
Experimental: Patients with Vibration
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
Device: Repeated Muscle Vibration (rMV)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb Fugl Meyer Assessment Score (UL-FMA)
Time Frame: 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.
Day 4 from start of experiment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb strength
Time Frame: 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
Day 4 from start of experiment
SAFE Score
Time Frame: 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
Day 4 from start of experiment
muscular mass of the impaired upper limb
Time Frame: Day 4 from start of experiment
Day 4 from start of experiment
Phase angle of the impaired upper limb
Time Frame: Day 4 from start of experiment
Day 4 from start of experiment
Motricity Index (Demeurisse)
Time Frame: 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.
Day 4 from start of experiment
Total NIHSS
Time Frame: 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.
Day 4 from start of experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Canan OZSANCAK, MD, CHU Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2024-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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