Idiopathic Parkinson's DiseaseGONDOLAPILOTANCT01815281
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy.
A study testing Foot Mechanical Stimulation (GONDOLA) in people with Idiopathic Parkinson's Disease and Progressive Supranuclear Palsy, run by IRCCS San Raffaele Roma at 3 sites in Italy.
Trial summary
The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Parkinson's Disease, Progressive Supranuclear Palsy
- What is being tested?
- Foot Mechanical Stimulation (GONDOLA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- Jul 2013to Apr 2015
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
- Able to walk 25 feet unassisted or with minimal assistance;
- On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
- Endurance sufficient to stand at least 20 minutes unassisted per patient report.
Who cannot join
- Other significant neurological or orthopedic problems.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
San Raffaele Cassino
Cassino, FR
University Campus Biomedico of Rome
Rome, 00128
IRCCS San Raffaele Roma
Rome, 00163
About this study
Official title: Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease
The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
- Being tested
- Foot Mechanical Stimulation (GONDOLA)
- Medical subject headings
- Parkinson Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Mechanical Stimulation (GONDOLA)Device
Also called GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
| Study group | Role | What they receive |
|---|---|---|
| Foot Mechanical Stimulation | Experimental | The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Receives: Device: Foot Mechanical Stimulation (GONDOLA) |
| Footh Mechanical Stimulation | Sham comparator | The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Receives: Device: Foot Mechanical Stimulation (GONDOLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go.
Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).
Measured: Change from Baseline in Timed Up and Go test at 1 month follow up.
Secondary outcomes (4)
6 minuts walking test.
6 minuts walking test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).
Measured: Change from Baseline in gait speed at 1 month follow up
Gait Parameters
Gait Analysis will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).
Measured: Change from Baseline in Gait Parameters at 1 month follow up
FREEZING OF GAIT QUESTIONNAIRES
Measured: Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)
Measured: Change from Baseline in PDQ-39 at 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson's 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio Stocchi, MD, Principal investigator, IRCCS San Raffaele Pisana Rome ItalyMichela Goffredo, BME, Study director, IRCCS San Raffaele Pisana Rome Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815281
- Sponsor's protocol ID
- RP 12/13
- Acronym
- GONDOLAPILOTA
- Status last verified
- Mar 2015
- First submitted
- 14 Mar 2013
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015.
PubMed 26469868
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01815281
- Acronym / sponsor ID
- GONDOLAPILOTA / RP 12/13
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Mar 2013 (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 this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
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 |
|---|---|---|
| Foot Mechanical Stimulation | Experimental | Device: Foot Mechanical Stimulation (GONDOLA)The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). |
| Footh Mechanical Stimulation | Sham comparator | Device: Foot Mechanical Stimulation (GONDOLA)The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
- Able to walk 25 feet unassisted or with minimal assistance;
- On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
- Endurance sufficient to stand at least 20 minutes unassisted per patient report.
Key exclusion criteria (1 listed)
- Other significant neurological or orthopedic problems.
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 |
|---|---|---|
| Foot Mechanical Stimulation (GONDOLA)Also: GONDOLA equipment (Ecker Technologies Sagl, Switzerland). | Device | Foot Mechanical Stimulation, Footh Mechanical Stimulation |
Primary outcome
Timed Up and Go.
Time frame: Change from Baseline in Timed Up and Go test at 1 month follow up.
Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).
4 secondary outcomes
6 minuts walking test.
Time frame: Change from Baseline in gait speed at 1 month follow up
Gait Parameters
Time frame: Change from Baseline in Gait Parameters at 1 month follow up
FREEZING OF GAIT QUESTIONNAIRES
Time frame: Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)
Time frame: Change from Baseline in PDQ-39 at 1 month follow up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 26469868Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015.
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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.
Fabrizio Stocchi, MD principal investigator
IRCCS San Raffaele Pisana Rome Italy
Michela Goffredo, BME study director
IRCCS San Raffaele Pisana Rome Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Mechanical Stimulation (GONDOLA) in people with Idiopathic Parkinson's Disease and Progressive Supranuclear Palsy, run by IRCCS San Raffaele Roma at 3 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 4 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: stopped early, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early. 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?
Timed Up and Go. (time frame: Change from Baseline in Timed Up and Go test at 1 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815281, which also lists 1 linked publication.
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 10 Apr 2024.