Efficiency of the Super Inductive System in Spasticity Treatment
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2019
CompletedStudy Start
First participant enrolled
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 19, 2022
May 1, 2022
3 years
December 2, 2019
May 18, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
change in MAS functional index
upper extremity functional index
day 0, day 10, day 30
change in Barthel index
measurement of activities of daily living
day 0, day 10, day 30
Study Arms (2)
Spasticity after stroke 1
EXPERIMENTALPhysical therapy with super inductive system on the agonist and antagonist muscles
Spasticity after stroke 2
ACTIVE COMPARATORPhysical therapy with super inductive system on the antagonist muscles
Interventions
Super inductive system (high frequency electromagnetic field)
Eligibility Criteria
You may qualify if:
- spasticity after stroke
You may not qualify if:
- spasticity of other causes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Rehabilitation Hospital
Cluj-Napoca, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viorela M Ciortea, MD, PhD
University of Medicine and Pharmacy Iuliu Hatieganu
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 2, 2019
First Posted
December 9, 2019
Study Start
December 4, 2019
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
May 19, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- at the end of the study
- Access Criteria
- on demand by e-mail
if solicited