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Focal Muscular Vibration to Treat Upper Limb Spasticity in Stroke

NCT04087928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-02-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

FMV_flex

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

DEVICE

FMV_ext

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

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Irene Aprile, MD, PhD · IRCCS Fondazione Don Carlo Gnocchi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087928 on ClinicalTrials.gov