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Efficiency of the Super Inductive System in Spasticity Treatment

Primary Purpose

Spasticity, Muscle

Status

Recruiting

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

Super inductive system (high frequency electromagnetic field)

Physical therapy

About this trial

This is an interventional treatment trial for Spasticity, Muscle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

spasticity after stroke

Exclusion Criteria:

spasticity of other causes

Sites / Locations

Clinical Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spasticity after stroke 1

Spasticity after stroke 2

Arm Description

Physical therapy with super inductive system on the agonist and antagonist muscles

Physical therapy with super inductive system on the antagonist muscles

Outcomes

Primary Outcome Measures

change in MAS functional index

upper extremity functional index

change in Barthel index

measurement of activities of daily living

Secondary Outcome Measures

Full Information

NCT ID

NCT04190238

First Posted

December 2, 2019

Last Updated

May 18, 2022

Sponsor

Universitatea de Medicina si Farmacie Iuliu Hatieganu

1. Study Identification

Unique Protocol Identification Number

NCT04190238

Brief Title

Efficiency of the Super Inductive System in Spasticity Treatment

Official Title

Efficiency of the Super Inductive System in Spasticity Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 4, 2019 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitatea de Medicina si Farmacie Iuliu Hatieganu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spasticity, Muscle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

case-control study

Masking

Care Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spasticity after stroke 1

Arm Type

Experimental

Arm Description

Physical therapy with super inductive system on the agonist and antagonist muscles

Arm Title

Spasticity after stroke 2

Arm Type

Active Comparator

Arm Description

Physical therapy with super inductive system on the antagonist muscles

Intervention Type

Other

Intervention Name(s)

Super inductive system (high frequency electromagnetic field)

Intervention Description

Super inductive system (high frequency electromagnetic field)

Intervention Type

Other

Intervention Name(s)

Physical therapy

Intervention Description

specific for spasticity

Primary Outcome Measure Information:

Title

change in MAS functional index

Description

upper extremity functional index

Time Frame

day 0, day 10, day 30

Title

change in Barthel index

Description

measurement of activities of daily living

Time Frame

day 0, day 10, day 30

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: spasticity after stroke Exclusion Criteria: spasticity of other causes

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alina D Ciubean, MD

Phone

0040744635364

alina.deniza.ciubean@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Viorela M Ciortea, MD, PhD

Organizational Affiliation

University of Medicine and Pharmacy Iuliu Hatieganu

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Rehabilitation Hospital

City

Cluj-Napoca

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Viorela M Ciortea, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

if solicited

IPD Sharing Time Frame

at the end of the study

IPD Sharing Access Criteria

on demand by e-mail

Learn more about this trial

Efficiency of the Super Inductive System in Spasticity Treatment

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