Repeated Muscle Vibration in Acute Stroke

Study Overview
=================
Brief Summary
-----------------
prospective randomized double-blind sham-controlled study aimed to investigate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients, treated within 72 hours from symptoms onset

Detailed Description
-----------------
This is a prospective randomized double-blind sham-controlled study. After enrollment (T-0), patients are randomly placed into the vibration group (VG) or the control group (CG), by using a computer-generated randomization list. VG patients receive rMV treatment while those of CG receive the sham one. Both treatments are carried out during the 1st, 2nd and 3rd day after enrollment. Physiokinesitherapy (PT) is carried out in all patients every day, starting soon after T-0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), at the end of treatment. Upon admission, all participants' demographic details and medical history are recorded. All patients undergo a clinical examination, performed at all time-points by an experienced investigator, blinded to group assignment and different from the recruiting one. Clinical evaluation consists of stroke severity evaluation, by means of NIH Stroke Scale; motor and functional limbs abilities are evaluated by using both the Fugl-Meyer scale and the Motricity Index; post-stroke spasticity is assessed with Ashworth scale, modified by Bohannon and Smith. All participants undergo a daily rehabilitation program. The physical therapist is instructed about duration, frequency, and content of therapy in order to ensure uniformity in treatment procedures, and blinded to patients' treatment allocation. Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl). The rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle. Otherwise, the CG participants undergo the sham rMV by positioning the vibrator close to the tendon but without touching the skin. In this condition, patients are only subject to the faint buzzing sound of the vibrator

Official Title
-----------------
Effects of Repeated (Focal) Muscle Vibration (rMV) on Motor Recovery After Acute Stroke: a Randomized Sham-controlled Study

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Device: Vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18, first ever stroke detected by Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) scan ischemic or hemorrhagic stroke within 72 hours from symptom onset motor deficit of the upper and/or lower limb; ability to perform at least a minimal isometric voluntary contraction of the affected limb Exclusion Criteria: TIA, or rapidly improving stroke cerebral venous thrombosis patients presenting with aphasia, neglect, or apraxia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized double-blind sham-controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration Group (VG)<br>VG participants undergo rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle | Device: Vibration<br>* Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).<br>* Other names: Repeated (focal) Muscle Vibration (rMV);|
| Sham Comparator: Control Group (CG)<br>CG participants undergo the sham rMV by positioning the vibrator close to the tendon but without touching the skin. In this condition, patients were only subject to the faint buzzing sound of the vibrator. Sham rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle | Device: Vibration<br>* Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).<br>* Other names: Repeated (focal) Muscle Vibration (rMV);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Recovery | Motor recovery is expressed as the differences over time (from T-0 to T-1) between the two groups concerning Motricity Index scale scores. The Motricity Index is an ordinal scale that evaluates motor skills and functional limbs in patients with neurological diseases. The movements object of the evaluation are in total 6 (3 for each limb) The scores range from 0 (i.e. no movement) to 33 (ie normal movements) for a maximum of 100 for each limb. | 4 ± 1 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Recovery within/associated to synergies | Motor recovery occurring within/associated to synergies is expressed as the differences over time (from T-0 to T-1) between the two groups concerning Fugl-Meyer scale scores. This scale consists of 10 subtests (6 subtests for the upper limb and 4 for the lower limbs), which evaluate the movements occurring within the synergies (flexor or extensor) and the movements that occur with the association of synergies. It consists of 50 items and provides a maximum score of 100 points, which corresponds to normal traction (66 points for the upper limb, 34 for the lower one) and a minimum score of 0 (no traction) | 4 ± 1 days | 
| Stroke Recovery | Stroke recovery is expressed as the differences over time (from T-0 to T-1) between the two groups concerning NIH Stroke Scale scores. This scale assesses the stroke severity; it consists of 11 items and the total score goes from a minimum of 0 = normal neurological examination at a maximum of 42, severe severe neurological deficit. | 4 ± 1 days | 
| Spasticity Recovery | Post-stroke Spasticity is assessed with Ashworth scale, modified by Bohannon and Smith. The total score goes from 0 (no spasticity) to 4 (maximum spasticity grade) | 4 ± 1 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
repetitive muscle vibration (rMV), acute stroke, motor recovery, nonpharmacological therapy, bedside intervention