Efficiency of the Super Inductive System in Spasticity Treatment

Spasticity, Muscle Clinical Trial

Official title:

Efficiency of the Super Inductive System in Spasticity Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190238
• Other study ID #: UniversitateaMFHCJ
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

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