Efficiency of the Super Inductive System in Spasticity Treatment

May 18, 2022 updated by: Ciubean Alina Deniza, Universitatea de Medicina si Farmacie Iuliu Hatieganu
The aim of the study is to see whether a physical therapy program can relieve pain, decrease spasticity and increase muscle contraction force by using the super inductive system (high frequency electromagnetic field). It is a longitudinal, prospective study, of 60 patients with spasticity after stroke. No new treatment method is tested, as the Super inductive system is approved for physical therapy by the Ministry of Health.

Study Overview

Detailed Description

The 60 patients will be submitted to 2 treatment groups: 30 patients will receive 10 sessions of the superinductive system on the antagonist muscles, and 30 patients will receive 10 sessions the superinductive system on the agonist and antagonist muscles. All patients will also receive the standard kinetotherapy program for spasticity. The patients will be evaluated at the beginning of the treatment, at 10 days and at 30 days by using the functional MAS index and Barthel index.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Cluj-Napoca, Romania
        • Recruiting
        • Clinical Rehabilitation Hospital
        • Contact:
          • Viorela M Ciortea, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spasticity after stroke

Exclusion Criteria:

  • spasticity of other causes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spasticity after stroke 1
Physical therapy with super inductive system on the agonist and antagonist muscles
Super inductive system (high frequency electromagnetic field)
specific for spasticity
Active Comparator: Spasticity after stroke 2
Physical therapy with super inductive system on the antagonist muscles
Super inductive system (high frequency electromagnetic field)
specific for spasticity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in MAS functional index
Time Frame: day 0, day 10, day 30
upper extremity functional index
day 0, day 10, day 30
change in Barthel index
Time Frame: day 0, day 10, day 30
measurement of activities of daily living
day 0, day 10, day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Viorela M Ciortea, MD, PhD, University of Medicine and Pharmacy Iuliu Hatieganu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

if solicited

IPD Sharing Time Frame

at the end of the study

IPD Sharing Access Criteria

on demand by e-mail

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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