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Efficiency of the Super Inductive System in Spasticity Treatment

Sponsor
Universitatea de Medicina si Farmacie Iuliu Hatieganu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04190238
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Super inductive system (high frequency electromagnetic field)
  • Other: Physical therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
case-control studycase-control study
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Efficiency of the Super Inductive System in Spasticity Treatment
Actual Study Start Date :
Dec 4, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spasticity after stroke 1

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

Other: Super inductive system (high frequency electromagnetic field)
Super inductive system (high frequency electromagnetic field)

Other: Physical therapy
specific for spasticity
Active Comparator: Spasticity after stroke 2

Physical therapy with super inductive system on the antagonist muscles

Other: Super inductive system (high frequency electromagnetic field)
Super inductive system (high frequency electromagnetic field)

Other: Physical therapy
specific for spasticity

Outcome Measures

Primary Outcome Measures

  1. change in MAS functional index [day 0, day 10, day 30]

    upper extremity functional index

  2. change in Barthel index [day 0, day 10, day 30]

    measurement of activities of daily living

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • spasticity after stroke
Exclusion Criteria:
  • spasticity of other causes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Rehabilitation Hospital Cluj-Napoca Romania

Sponsors and Collaborators

  • Universitatea de Medicina si Farmacie Iuliu Hatieganu

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ciubean Alina Deniza, Principal investigator, Universitatea de Medicina si Farmacie Iuliu Hatieganu
ClinicalTrials.gov Identifier:
NCT04190238
Other Study ID Numbers:
  • UniversitateaMFHCJ
First Posted:
Dec 9, 2019
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Muscle Spasticity

Study Results

No Results Posted as of May 19, 2022