CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
FMV_flex +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04087928
NCT04087928N/ACompleted

Efficacy of Focal Muscular Vibration in the Treatment of Upper Limb Spasticity in Subjects With Stroke Outcomes: Randomized Controlled Trial.

Fondazione Don Carlo Gnocchi Onlus·interventional·Posted Sep 12, 2019·Updated Feb 6, 2020

In Brief

A clinical study evaluating FMV_flex and FMV_ext for Stroke. Completed, enrolled 28 participants across 1 site.

Detailed Summary

Spasticity following stroke is one of the most debilitating conditions and has a negative influence on the autonomy and quality of life, and greatly worsens the patient's degree of disability. Focal muscular vibration (FMV) is a non-invasive technique to treat spasticity. Has been showed the positive effects of FMV on spasticity in stroke subjects. FMV has been investigated on the antagonist muscle, as well as directly on the spastic muscle, showing in both cases a significant reduction in spasticity. However, isn't unclear which is the most effective in the treatment of spasticity. The objective of the study is to evaluate the efficacy of FMV of the muscles of the upper limb in subjects with subacute stroke, comparing the effects obtained by treating the spastic muscles directly versus to those obtained by treating the respective antagonist muscles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 12, 2019
Enrollment StartSep 16, 2019
Primary CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.8 years ago

Interventions

FMV_flexdevice

Fisiocomputer EVM (Endomedica, Italy) for application of FMV to flexor muscles of the upper limb (brachial biceps and carpal flexors).

FMV_extdevice

Fisiocomputer EVM (Endomedica, Italy) for application of FMV to extensors muscles of the upper limb (triceps brachial and carpus extensors).