Efficiency of the Super Inductive System in Spasticity Treatment

Not Applicable

• Conditions: Spasticity, Muscle
• Interventions: Other: Super inductive system (high frequency electromagnetic field); Other: Physical therapy

• Registration Number: NCT04190238
• Lead Sponsor: Universitatea de Medicina si Farmacie Iuliu Hatieganu

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.

Study Timeline

• Study First Submitted: 2019-12-02
• Study Start: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• spasticity after stroke

Exclusion Criteria

• spasticity of other causes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spasticity after stroke 1	Physical therapy	Physical therapy with super inductive system on the agonist and antagonist muscles
Spasticity after stroke 2	Physical therapy	Physical therapy with super inductive system on the antagonist muscles
Spasticity after stroke 1	Super inductive system (high frequency electromagnetic field)	Physical therapy with super inductive system on the agonist and antagonist muscles
Spasticity after stroke 2	Super inductive system (high frequency electromagnetic field)	Physical therapy with super inductive system on the antagonist muscles

Primary Outcome Measures

Name	Time	Method
change in Barthel index	day 0, day 10, day 30	measurement of activities of daily living
change in MAS functional index	day 0, day 10, day 30	upper extremity functional index

Trial Locations

Locations (1)

Clinical Rehabilitation Hospital; 🇷🇴 Cluj-Napoca, Romania