Repeated Muscle Vibration in Acute Stroke
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
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).
Other Names:
|
| Sham Comparator: 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 |
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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Motor Recovery [4 ± 1 days]
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.
Secondary Outcome Measures
- Motor Recovery within/associated to synergies [4 ± 1 days]
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)
- Stroke Recovery [4 ± 1 days]
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.
- Spasticity Recovery [4 ± 1 days]
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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Human Neurosciences, "Sapienza" University of Rome | Rome | Italy | 00184 |
Sponsors and Collaborators
- University of Roma La Sapienza
Investigators
- Principal Investigator: Vittorio Di Piero, Prof, Università di Roma La Sapienza
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- URomLS - VDiPiero