Repeated Muscle Vibration in Acute Stroke

NCT03697525 | Completed DMC

• 1 other identifier: URomLS - VDiPiero
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Stroke

Keywords

repetitive muscle vibration (rMV); acute stroke; motor recovery; nonpharmacological therapy; bedside intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  4 ± 1 days

Secondary Outcomes (3)

• Motor Recovery within/associated to synergies

  4 ± 1 days

• Stroke Recovery

  4 ± 1 days

• Spasticity Recovery

  4 ± 1 days

Study Arms (2)

Vibration Group (VG)

EXPERIMENTAL

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

Control Group (CG)

SHAM COMPARATOR

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

Interventions

Vibration 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).

Also known as: Repeated (focal) Muscle Vibration (rMV)

Control Group (CG); Vibration Group (VG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• TIA, or rapidly improving stroke
• cerebral venous thrombosis
• patients presenting with aphasia, neglect, or apraxia

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Human Neurosciences, "Sapienza" University of Rome

Rome, 00184, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vittorio Di Piero, Prof

  Università di Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective randomized double-blind sham-controlled study

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 5, 2018
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: March 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)