Repeated Muscle Vibration in Acute Stroke

NCT ID: NCT03697525

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2020-03-01

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

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vibration Group (VG)

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

Group Type: EXPERIMENTAL

Vibration

Intervention Type: DEVICE

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).

Control Group (CG)

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

Group Type: SHAM_COMPARATOR

Vibration

Intervention Type: DEVICE

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).

Interventions

Vibration

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).

Intervention Type: DEVICE

Other Intervention Names

Repeated (focal) Muscle Vibration (rMV)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Vittorio Di Piero

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vittorio Di Piero, Prof

Role: PRINCIPAL_INVESTIGATOR

Università di Roma La Sapienza

Locations

Department of Human Neurosciences, "Sapienza" University of Rome

Rome, , Italy

Countries

Italy

Other Identifiers

URomLS - VDiPiero

Identifier Type: -

Identifier Source: org_study_id