Multiple SclerosisNCT02848898
The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients
A study testing Equistasi in people with Multiple Sclerosis, run by Federico II University at 1 site in Italy.
Trial summary
This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Equistasi
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2016to Jul 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Sclerosis affected
- Spasticity
- EDSS (Expanded Disability Status Scale) 0 - 5,5
- Patients able to sign informed consent
Who cannot join
- Age less than 18 years old and more than 65 years old
- Pacemaker
- Pregnancy
- Comorbidities as: cancer, hypertension not controlled by drugs
- concurrent therapies with antidepressant or corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study
This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.
- Conditions
- Multiple Sclerosis
- Being tested
- Equistasi, Placebo
- Keywords
- Focal Vibrations, Neurorehabilitation, Spasticity, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EquistasiDevice
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Equistasi Group | Experimental | arm treated with application of devices Receives: Device: Equistasi |
| Placebo Group | Placebo comparator | arm treated with application of inactivated devices Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity
evaluation of gait velocity in m/s
Measured: one year
First step length
first step length in cm
Measured: one year
Swing phase
swing phase measured in seconds
Measured: one year
Stance phase
stance phase measured in seconds
Measured: one year
Double support time
double support time measured in seconds
Measured: one year
Secondary outcomes (3)
H/M ratio
evaluation of neurophysiological modifications in treated patients vs placebo group, as ratio between H max and M max in tibial posterior nerve, in Unit
Measured: one year
Berg Balance Scale
Evaluation of balance with a self administered scale, measured in Unit
Measured: one year
Modified Fatigue Scale
evaluation of fatigue with a self administered scale, measured in Unit
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Spina, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848898
- Sponsor's protocol ID
- 71/15
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study
- ClinicalTrials.gov ID
- NCT02848898
- Acronym / sponsor ID
- 71/15
- Conditions
- Multiple Sclerosis
- Keywords
- Focal Vibrations, Neurorehabilitation, Spasticity, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- 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.
This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equistasi Group | Experimental | Device: Equistasiarm treated with application of devices |
| Placebo Group | Placebo comparator | Other: Placeboarm treated with application of inactivated devices |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Multiple Sclerosis affected
- Spasticity
- EDSS (Expanded Disability Status Scale) 0 - 5,5
- Patients able to sign informed consent
Key exclusion criteria (5 listed)
- Age less than 18 years old and more than 65 years old
- Pacemaker
- Pregnancy
- Comorbidities as: cancer, hypertension not controlled by drugs
- concurrent therapies with antidepressant or corticosteroids
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 |
|---|---|---|
| Equistasi | Device | Equistasi Group |
| Placebo | Other | Placebo Group |
Primary outcome
Gait Velocity
Time frame: one year
evaluation of gait velocity in m/s
First step length
Time frame: one year
first step length in cm
Swing phase
Time frame: one year
swing phase measured in seconds
Stance phase
Time frame: one year
stance phase measured in seconds
Double support time
Time frame: one year
double support time measured in seconds
3 secondary outcomes
H/M ratio
Time frame: one year
Berg Balance Scale
Time frame: one year
Modified Fatigue Scale
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equistasi in people with Multiple Sclerosis, run by Federico II University at 1 site in Italy.
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 4 inclusion and 5 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 29 Jul 2016. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity (time frame: one year). The study lists 5 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 29 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.