Clinical trial NCT03697525: Repeated Muscle Vibration in Acute Stroke
Official title: Effects of Repeated (Focal) Muscle Vibration (rMV) on Motor Recovery After Acute Stroke: a Randomized Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: repetitive muscle vibration (rMV)
acute stroke
motor recovery
nonpharmacological therapy
bedside intervention
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized double-blind sham-controlled study
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Motor Recovery
timeFrame: 4 ± 1 days
Secondary outcomes:
measure: Motor Recovery within/associated to synergies
timeFrame: 4 ± 1 days
measure: Stroke Recovery
timeFrame: 4 ± 1 days
measure: Spasticity Recovery
timeFrame: 4 ± 1 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Human Neurosciences, "Sapienza" University of Rome
Study officials:
affiliation: Università di Roma La Sapienza
name: Vittorio Di Piero, Prof
role: PRINCIPAL_INVESTIGATOR
References: