HemiparesisPhase 4NCT02714478
"Equistasi" and Gait in Hemiparesis
A Phase 4 study testing equistasi in people with Hemiparesis, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparesis
- 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
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Dec 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subacute hemiparesis
- Functional Ambulation Classification <4
Who cannot join
- previous neurological deficits
- Glasgow Coma Scale <13
- Complete sensory deficit in the lower limbs
- Levels of Cognitive Functioning ≤5
- polyneuropathy
- contraindications to mobilization/verticalization
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital
Gravedona, CO, 22015
Giuseppe Frazzitta, MD, +39033492705, frazzittag62@gmail.com
About this study
Official title: Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident
The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.
- Conditions
- Hemiparesis
- Being tested
- equistasi, placebo
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
equistasiDevice
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
placeboDevice
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | 3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks Receives: Device: equistasi |
| controls | Placebo comparator | 3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
disability change assessed using Functional Independence Measure scale
Measured: 0. 30. 60. 120 days
balance change assessed using Berg Balance Scale
Measured: 0. 30. 60. 120 days
gait pattern change assessed using Functional Ambulation Classification scale
Measured: 0. 30. 60. 120 days
gait speed change assessed using Timed Up and Go scale
Measured: 0. 30. 60. 120 days
gait pattern change using Tinetti scale for gait
Measured: 0. 30. 60. 120 days
gait speed change assessed using 10 meter walking test scale
Measured: 0. 30. 60. 120 days
swaying of the center of gravity change assessed with stabilometric platform indexes
Measured: 0. 30. 60. 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714478
- Sponsor's protocol ID
- Equistasi.01
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident
- ClinicalTrials.gov ID
- NCT02714478
- Acronym / sponsor ID
- Equistasi.01
- Conditions
- Hemiparesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 21 Mar 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.
The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: equistasi3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks |
| controls | Placebo comparator | Device: placebo3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subacute hemiparesis
- Functional Ambulation Classification <4
Key exclusion criteria (6 listed)
- previous neurological deficits
- Glasgow Coma Scale <13
- Complete sensory deficit in the lower limbs
- Levels of Cognitive Functioning ≤5
- polyneuropathy
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 |
|---|---|---|
| equistasi3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy | Device | treatment |
| placebo3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy | Device | controls |
Primary outcome
disability change assessed using Functional Independence Measure scale
Time frame: 0. 30. 60. 120 days
balance change assessed using Berg Balance Scale
Time frame: 0. 30. 60. 120 days
gait pattern change assessed using Functional Ambulation Classification scale
Time frame: 0. 30. 60. 120 days
gait speed change assessed using Timed Up and Go scale
Time frame: 0. 30. 60. 120 days
gait pattern change using Tinetti scale for gait
Time frame: 0. 30. 60. 120 days
gait speed change assessed using 10 meter walking test scale
Time frame: 0. 30. 60. 120 days
swaying of the center of gravity change assessed with stabilometric platform indexes
Time frame: 0. 30. 60. 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing equistasi in people with Hemiparesis, run by Ospedale Generale Di Zona Moriggia-Pelascini 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 2 inclusion and 6 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 30 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Giuseppe Frazzitta, MD (+39033492705, frazzittag62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disability change assessed using Functional Independence Measure scale (time frame: 0. 30. 60. 120 days). The study lists 7 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 30 Sep 2016.