Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03697525
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Active, not recruiting
Phase N/A
Start date January 1, 2016
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT03477188 - The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke. N/A
Recruiting NCT02677415 - Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment N/A
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Completed NCT01210729 - Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke Phase 2
Recruiting NCT00785343 - Study of Robot-assisted Arm Therapy for Acute Stroke Patients Phase 1
Recruiting NCT02369770 - Sensory-Motor Rehabilitation Post Stroke N/A
Not yet recruiting NCT03359434 - Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke N/A
Completed NCT02720276 - Sms Guided Training After Acute Stroke N/A
Completed NCT03036020 - The Norwegian Acute Stroke Prehospital Project N/A
Completed NCT01501773 - Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke Phase 2
Terminated NCT00331890 - ICTUS Study: International Citicoline Trial on Acute Stroke Phase 3
Not yet recruiting NCT03144960 - Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke N/A
Recruiting NCT02902367 - Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial N/A
Withdrawn NCT02098083 - Evaluation of Physical Therapy Interventions and Patient Characteristics on Outcomes N/A
Terminated NCT01692379 - Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours Phase 3
Not yet recruiting NCT01442766 - Donepezil Trial for Motor Recovery in Acute Stroke Phase 1/Phase 2
Withdrawn NCT02907736 - Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients
Recruiting NCT03297827 - Cytokine Registry Database of Stroke Patients
Not yet recruiting NCT03720522 - The Bern Heart and Brain Interaction Study - Interaction Between Brain and Heart in Acute Ischemic Stroke