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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04190238
Other study ID # UniversitateaMFHCJ
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2019
Est. completion date December 2022

Study information

Verified date May 2022
Source Universitatea de Medicina si Farmacie Iuliu Hatieganu
Contact Alina D Ciubean, MD
Phone 0040744635364
Email alina.deniza.ciubean@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - spasticity after stroke Exclusion Criteria: - spasticity of other causes

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Super inductive system (high frequency electromagnetic field)
Super inductive system (high frequency electromagnetic field)
Physical therapy
specific for spasticity

Locations

Country Name City State
Romania Clinical Rehabilitation Hospital Cluj-Napoca

Sponsors (1)

Lead Sponsor Collaborator
Universitatea de Medicina si Farmacie Iuliu Hatieganu

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in MAS functional index upper extremity functional index day 0, day 10, day 30
Primary change in Barthel index measurement of activities of daily living day 0, day 10, day 30
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