- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04190238
Efficiency of the Super Inductive System in Spasticity Treatment
May 18, 2022 updated by: Ciubean Alina Deniza, Universitatea de Medicina si Farmacie Iuliu Hatieganu
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alina D Ciubean, MD
- Phone Number: 0040744635364
- Email: alina.deniza.ciubean@gmail.com
Study Locations
-
-
-
Cluj-Napoca, Romania
- Recruiting
- Clinical Rehabilitation Hospital
-
Contact:
- Viorela M Ciortea, MD,PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- spasticity after stroke
Exclusion Criteria:
- spasticity of other causes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spasticity after stroke 1
Physical therapy with super inductive system on the agonist and antagonist muscles
|
Super inductive system (high frequency electromagnetic field)
specific for spasticity
|
Active Comparator: Spasticity after stroke 2
Physical therapy with super inductive system on the antagonist muscles
|
Super inductive system (high frequency electromagnetic field)
specific for spasticity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in MAS functional index
Time Frame: day 0, day 10, day 30
|
upper extremity functional index
|
day 0, day 10, day 30
|
change in Barthel index
Time Frame: day 0, day 10, day 30
|
measurement of activities of daily living
|
day 0, day 10, day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Viorela M Ciortea, MD, PhD, University of Medicine and Pharmacy Iuliu Hatieganu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2019
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
December 2, 2019
First Submitted That Met QC Criteria
December 4, 2019
First Posted (Actual)
December 9, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversitateaMFHCJ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
if solicited
IPD Sharing Time Frame
at the end of the study
IPD Sharing Access Criteria
on demand by e-mail
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spasticity, Muscle
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingSpasticity, Muscle
-
Vancouver Island Health AuthorityRecruiting
-
Nantes University HospitalCompiègne University of TechnologyCompleted
-
University of AlbertaRecruiting
-
Rigshospitalet, DenmarkEnrolling by invitation
-
University of MalagaUnknownSpasticity, Muscle
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedSpasticity, MuscleTurkey
-
Medy-ToxCompletedSpasticity, Muscle
-
Shirley Ryan AbilityLabSuspended
-
Piramal Critical Care, Ltd.CompletedSevere SpasticityUnited States
Clinical Trials on Super inductive system (high frequency electromagnetic field)
-
Taipei Medical UniversityUnknownFatigue | Stress | Sleep Quality | Extremely Low Frequency Electromagnetic Field Device | Schumann ResonanceTaiwan
-
Tri-Service General HospitalNot yet recruiting
-
Tri-Service General HospitalRecruitingFrozen ShoulderTaiwan
-
Tri-Service General HospitalRecruitingRotator Cuff TendinosisTaiwan
-
BTL Industries Ltd.CompletedMuscle Tone IncreasedUnited States
-
BTL Industries Ltd.CompletedMuscle Tone IncreasedUnited States
-
St. Joseph's Healthcare HamiltonCompletedChanges in EEG During and After Magnetic StimulationCanada
-
Umm Al-Qura UniversityCompletedOsteopenia or OsteoporosisSaudi Arabia
-
Regenesis Biomedical, Inc.CompletedPost-Operative Pain Following Total Knee ArthroplastyUnited States