Spasticity, MuscleNCT04190238
Efficiency of the Super Inductive System in Spasticity Treatment
A study testing Super inductive system (high frequency electromagnetic field) and Physical therapy in people with Spasticity, Muscle, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- Super inductive system (high frequency electromagnetic field) and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- 4 Dec 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- spasticity after stroke
Who cannot join
- spasticity of other causes
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Clinical Rehabilitation Hospital
Cluj-Napoca
Viorela M Ciortea, MD,PhD
About this study
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.
Read the 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.
- Conditions
- Spasticity, Muscle
- Being tested
- Super inductive system (high frequency electromagnetic field), Physical therapy
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super inductive system (high frequency electromagnetic field)Other
Super inductive system (high frequency electromagnetic field)
Physical therapyOther
specific for spasticity
| Study group | Role | What they receive |
|---|---|---|
| Spasticity after stroke 1 | Experimental | Physical therapy with super inductive system on the agonist and antagonist muscles Receives: Other: Super inductive system (high frequency electromagnetic field); Other: Physical therapy |
| Spasticity after stroke 2 | Active comparator | Physical therapy with super inductive system on the antagonist muscles Receives: Other: Super inductive system (high frequency electromagnetic field); Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in MAS functional index
upper extremity functional index
Measured: day 0, day 10, day 30
change in Barthel index
measurement of activities of daily living
Measured: day 0, day 10, day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start4 Dec 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- case-control study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciubean Alina Deniza, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Viorela M Ciortea, MD, PhD, Principal investigator, University of Medicine and Pharmacy Iuliu Hatieganu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190238
- Sponsor's protocol ID
- UniversitateaMFHCJ
- Status last verified
- May 2022
- First submitted
- 2 Dec 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if solicited
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of the Super Inductive System in Spasticity Treatment
- ClinicalTrials.gov ID
- NCT04190238
- Acronym / sponsor ID
- UniversitateaMFHCJ
- Conditions
- Spasticity, Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- case-control study
| Arm | Type | Receives |
|---|---|---|
| Spasticity after stroke 1 | Experimental | Other: Super inductive system (high frequency electromagnetic field), Other: Physical therapyPhysical therapy with super inductive system on the agonist and antagonist muscles |
| Spasticity after stroke 2 | Active comparator | Other: Super inductive system (high frequency electromagnetic field), Other: Physical therapyPhysical therapy with super inductive system on the antagonist muscles |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- spasticity after stroke
Key exclusion criteria (1 listed)
- spasticity of other causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super inductive system (high frequency electromagnetic field)Super inductive system (high frequency electromagnetic field) | Other | Spasticity after stroke 1, Spasticity after stroke 2 |
| Physical therapyspecific for spasticity | Other | Spasticity after stroke 1, Spasticity after stroke 2 |
Primary outcome
change in MAS functional index
Time frame: day 0, day 10, day 30
upper extremity functional index
change in Barthel index
Time frame: day 0, day 10, day 30
measurement of activities of daily living
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Yes. if solicited
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viorela M Ciortea, MD, PhD principal investigator
University of Medicine and Pharmacy Iuliu Hatieganu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super inductive system (high frequency electromagnetic field) and Physical therapy in people with Spasticity, Muscle, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alina D Ciubean, MD (0040744635364, alina.deniza.ciubean@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in MAS functional index (time frame: day 0, day 10, day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.