An interventional study of Vibration in Acute Stroke, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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
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
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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).
Also known as: Repeated (focal) Muscle Vibration (rMV)
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.
Time frame: 4 ± 1 days
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)
Time frame: 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.
Time frame: 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)
Time frame: 4 ± 1 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Roma La Sapienza