Repeated Muscle Vibration in Acute Stroke
Sponsor:
University of Roma La Sapienza
Collaborators:
Information provided by (Responsible Party):
Vittorio Di Piero，University of Roma La Sapienza
| Tracking Information | |||
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| First Submitted Date ICMJE | September 29, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | January 1, 2016 | ||
| Estimated Primary Completion Date | July 1, 2018 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Motor Recovery[ Time Frame: 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Repeated Muscle Vibration in Acute Stroke |
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| Official Title ICMJE | Effects of Repeated (Focal) Muscle Vibration (rMV) on Motor Recovery After Acute Stroke: a Randomized Sham-controlled Study |
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| 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 |
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| 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 Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: prospective randomized double-blind sham-controlled study Masking: Interventional Masking Description:double-blind Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Active, not recruiting | ||
| Estimated Enrollment ICMJE |
22 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 31, 2019 | ||
| Estimated Primary Completion Date | July 1, 2018 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Italy | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Vittorio Di Piero，University of Roma La Sapienza | ||
| Study Sponsor ICMJE | University of Roma La Sapienza | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of Roma La Sapienza | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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