Parkinson DiseasePAGENCT02641405
Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
A study testing Equistasi and Inactive Equistasi in people with Parkinson Disease and Gait, Shuffling, run by I.R.C.C.S. Fondazione Santa Lucia at 6 sites in Italy.
Trial summary
It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Gait, Shuffling, Effects of Vibration
- What is being tested?
- Equistasi and Inactive Equistasi
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 6 sitesItaly
- Study dates
- Nov 2015to Jan 2019
- 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
- Patient with rigid-acinetic bilateral PD form
- At least 4 years of disease history
- H\&Y between 2-3
- Stable drug therapy response without any change performed in the 3 months before the study.
- Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy.
- MMSE>24/30 (Mini-Mental State Examination)
Who cannot join
- Systemic illness
- Presence of cardiac pacemaker
- Presence of deep brain stimulation
- Presence of severe dysautonomia with marked hypotension
- Obsessive-Compulsive disorder (OCD)
- Major depression
Show all 9Show fewer
- Dementia
- History or active neoplasia
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
IRCCS San Raffaele
Cassino
University of Genova
Genova
Istituto Auxologico Italiano
Oggebbio, Verbano-Cusio-Ossola, 28824
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, PV
IRCCS Santa Lucia
Rome, Lazio, 00179
Ospedale S. Raffaele Arcangelo, Fatebenefratelli
Venezia, 30121
About this study
It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. A total of 126 patients suffering from PD will be recruited in 6 italian neurological centers. The study will be a cross-over multicenter study with the randomization of the sequence. The patients will be randomly assigned to 2 groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. Finally a last recording will be taken at the end of the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific Balance Confidence Scale).
- Conditions
- Parkinson Disease, Gait, Shuffling, Effects of Vibration
- Being tested
- Equistasi, Inactive Equistasi
- Keywords
- Gait analysis, Proprioceptive focal stimulation, Parkinson
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EquistasiDevice
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs.
Inactive EquistasiDevice
Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs.
| Study group | Role | What they receive |
|---|---|---|
| Equistasi | Experimental | Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs. Receives: Device: Equistasi |
| Placebo | Placebo comparator | Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs. Receives: Device: Inactive Equistasi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Spatio-Temporal gait variables at 20 weeks
Measured: 20 weeks
Secondary outcomes (3)
Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks
Measured: 20 weeks
Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks
Measured: 20 weeks
Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano, IRCCS National Neurological Institute "C. Mondino" Foundation, Ospedale S. Raffaele Arcangelo, Fatebenefratelli, University of Genova, IRCCS San Raffaele
- Responsible party
- Principal investigator, Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641405
- Sponsor's protocol ID
- CE/PROG.478
- Acronym
- PAGE
- Status last verified
- Jan 2021
- First submitted
- 3 Dec 2015
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
- ClinicalTrials.gov ID
- NCT02641405
- Acronym / sponsor ID
- PAGE / CE/PROG.478
- Conditions
- Parkinson Disease, Gait, Shuffling, Effects of Vibration
- Keywords
- Gait analysis, Proprioceptive focal stimulation, Parkinson
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano, IRCCS National Neurological Institute "C. Mondino" Foundation, Ospedale S. Raffaele Arcangelo, Fatebenefratelli, University of Genova, IRCCS San Raffaele
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 29 Dec 2015 (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.
It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. A total of 126 patients suffering from PD will be recruited in 6 italian neurological centers. The study will be a cross-over multicenter study with the randomization of the sequence. The patients will be randomly assigned to 2 groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. Finally a last recording will be taken at the end of the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific Balance Confidence Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equistasi | Experimental | Device: EquistasiEquistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs. |
| Placebo | Placebo comparator | Device: Inactive EquistasiInactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with rigid-acinetic bilateral PD form
- At least 4 years of disease history
- H\&Y between 2-3
- Stable drug therapy response without any change performed in the 3 months before the study.
- Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy.
Key exclusion criteria (9 listed)
- Systemic illness
- Presence of cardiac pacemaker
- Presence of deep brain stimulation
- Presence of severe dysautonomia with marked hypotension
- Obsessive-Compulsive disorder (OCD)
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 |
|---|---|---|
| EquistasiEquistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs. | Device | Equistasi |
| Inactive EquistasiInactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs. | Device | Placebo |
Primary outcome
Changes in Spatio-Temporal gait variables at 20 weeks
Time frame: 20 weeks
3 secondary outcomes
Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks
Time frame: 20 weeks
Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks
Time frame: 20 weeks
Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equistasi and Inactive Equistasi in people with Parkinson Disease and Gait, Shuffling, run by I.R.C.C.S. Fondazione Santa Lucia at 6 sites 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Spatio-Temporal gait variables at 20 weeks (time frame: 20 weeks). 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 12 Jan 2021.