Parkinson DiseaseGondoPark V2NCT03843268

Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease

A study testing AMPS Gondola in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: AMPS Gondola
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 1 siteItaly
Study dates: 1 Dec 2017to 30 Sep 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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with clinically chronic and stable PD, confirmed according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBC);
Age 45 and older;
Hoehn \& Yahr (H\&Y) stage equal or higher than 2 in ON state;
Ability to walk autonomously or with minimal assistance for a 10 meters' distance in OFF state;
Antiparkinsonian treatment at a stable and optimized daily dosage during the 4 weeks prior to the study.

Who cannot join

Any advanced, severe or unstable disease other than PD, which may interfere with the primary and secondary study outcome evaluations (autonomic dysfunction, diabetes, renal or hepatic failure, neoplasia, balance and gait problems of other origin).
Cognitive impairment with MoCA < 18
Any peripheral neurological or musculoskeletal conditions that may alter balance and/or gait.
Severe lower limb injuries in the previous 6 months.
History of neurosurgery or orthopedic surgery.
History of epilepsy.

Show all 9Show fewer

Any drug treatment not intended to treat PD that may alter cognitive and/or motor performance.
History of depression or other psychiatric disorders.
Severe obesity defined as a BMI greater than 35.

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS San Raffaele
Roma, 00163

Other trials in Italy

About this study

Official title: Multi-center, Double-blind, Cross-over Randomized Study on the Use of the Medical Device "Gondola" for Motor Rehabilitation in Patients With Parkinson's Disease

The purpose of this research study is to evaluate safety and effectiveness of the Automated Mechanical Peripheral Stimulation (AMPS) therapy given via the Gondola™ device to improving Gait and Gait Related Disorders in patients with Parkinson'disease (PD). Gondola® is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the therapy requires less than 2 minutes.

Read the detailed description

The proposed project, through a randomized multicentric, placebo controlled double-blind crossover trial aimed at evaluating the effectiveness of AMPS Gondola therapy versus Sham Gondola therapy in PD subjects. 132 in/outpatients with PD will be recruited. Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subjects will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS); a follow up valuation 14 days after the end of each treatment cycle will be performed.

This project is aimed at studying and documenting the effects of the AMPS treatment given to PD patients via the Gondola device in:

Improving gait, reducing bradykinesia, treating Freezing of Gait symptom;
Improving UPDRS II and III scores;
Improving balance. Another goal of the study is to document the safety of the Gondola device.

Conditions: Parkinson Disease
Being tested: AMPS Gondola, Sham Gondola
Keywords: Automated Mechanical Peripheral Stimulation (AMPS), Gait Disorders
Medical subject headings: Parkinson Disease, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMPS GondolaDevice
Gondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the treatment requires less than 2 minutes.
Sham GondolaDevice
The Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger

Study groups in NCT03843268
Study group	Role	What they receive
AMPS Gondola	Active comparator	Gondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS) Receives: Device: AMPS Gondola; Device: Sham Gondola
Sham Gondola	Placebo comparator	The Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger. Receives: Device: AMPS Gondola; Device: Sham Gondola

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
Study success will be defined by an:
improvement in gait speed of no less than 0,06 m/s as follows: H0: DT treatment phase - DT Sham phase < 0.06m/s v.s. Ha: DT treatment phase - DT Sham phase ≥ 0.06m/s
Where:
DT = VPost6 - VPre VPost 6= gait speed after 6 treatment stimulations (at the end of the treatment cycle) Vpre = gait speed before the 1st treatment stimulation (at the beginning of the treatment cycle)
Measured: through study completion, an average of 16 weeks

Secondary outcomes (4)

Change in clinical evaluation in MDS-UPDRS
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease (MDS-UPDRS) range from 0 - less affect - to 272 - more affect
Measured: through study completion, an average of 16 weeks
Change in clinical evaluation of step speed
step length measured in meters per second
Measured: through study completion, an average of 16 weeks
Change in time in walking
time needed to perform the 10 meters walking test (seconds)
Measured: through study completion, an average of 16 weeks
Change in clinical evaluation in FOG-Q
FOG-Q is a questionnaire to assess Freezing of gait (FOG) and walking among patients with Parkinson's disase (range from 0 - less affect - to 24 -more affect)
Measured: through study completion, an average of 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201730 Sep 2019

First posted18 Feb 2019
Study start1 Dec 2017
Primary completion30 Sep 2019
Study completion30 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Model description: Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subject will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS)
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03843268
Sponsor's protocol ID: RP 13/17
Acronym: GondoPark V2
Status last verified: Oct 2022
First submitted: 12 Feb 2019
Last updated: 10 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Semprini R, Sale P, Foti C, Fini M, Franceschini M. Gait impairment in neurological disorders: a new technological approach. Funct Neurol. 2009 Oct-Dec;24(4):179-83.
PubMed 20412722
Nieuwboer A, Dom R, De Weerdt W, Desloovere K, Fieuws S, Broens-Kaucsik E. Abnormalities of the spatiotemporal characteristics of gait at the onset of freezing in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1066-75. doi: 10.1002/mds.1206.
PubMed 11748737
Lo AC, Chang VC, Gianfrancesco MA, Friedman JH, Patterson TS, Benedicto DF. Reduction of freezing of gait in Parkinson's disease by repetitive robot-assisted treadmill training: a pilot study. J Neuroeng Rehabil. 2010 Oct 14;7:51. doi: 10.1186/1743-0003-7-51.
PubMed 20946640
De Pandis MF, Tomino C, Proietti S, Rotondo R, Gaglione M, Casali M, Corbo M, di Biase L, Galli M, Goffredo M, Stocchi F. Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson's disease: a multi-centre, double-blind, crossover randomized controlled trial. J Neuroeng Rehabil. 2025 Apr 8;22(1):77. doi: 10.1186/s12984-025-01574-3.
PubMed 40200338

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Multi-center, Double-blind, Cross-over Randomized Study on the Use of the Medical Device "Gondola" for Motor Rehabilitation in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT03843268
Acronym / sponsor ID: GondoPark V2 / RP 13/17
Conditions: Parkinson Disease
Keywords: Automated Mechanical Peripheral Stimulation (AMPS), Gait Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: IRCCS San Raffaele RomaUniversity, hospital or other
Study start: 1 Dec 2017 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 30 Sep 2019 (actual)
First posted: 18 Feb 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.

Detailed description

This project is aimed at studying and documenting the effects of the AMPS treatment given to PD patients via the Gondola device in:

Improving gait, reducing bradykinesia, treating Freezing of Gait symptom;
Improving UPDRS II and III scores;
Improving balance. Another goal of the study is to document the safety of the Gondola device.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subject will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS)

Arm	Type	Receives
AMPS Gondola	Active comparator	Device: AMPS Gondola, Device: Sham GondolaGondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS)
Sham Gondola	Placebo comparator	Device: AMPS Gondola, Device: Sham GondolaThe Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with clinically chronic and stable PD, confirmed according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBC);
Age 45 and older;
Hoehn \& Yahr (H\&Y) stage equal or higher than 2 in ON state;
Ability to walk autonomously or with minimal assistance for a 10 meters' distance in OFF state;
Antiparkinsonian treatment at a stable and optimized daily dosage during the 4 weeks prior to the study.

Key exclusion criteria (9 listed)

Any advanced, severe or unstable disease other than PD, which may interfere with the primary and secondary study outcome evaluations (autonomic dysfunction, diabetes, renal or hepatic failure, neoplasia, balance and gait problems of other origin).
Cognitive impairment with MoCA < 18
Any peripheral neurological or musculoskeletal conditions that may alter balance and/or gait.
Severe lower limb injuries in the previous 6 months.
History of neurosurgery or orthopedic surgery.

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
AMPS GondolaGondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the treatment requires less than 2 minutes.	Device	AMPS Gondola, Sham Gondola
Sham GondolaThe Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger	Device	AMPS Gondola, Sham Gondola

Primary outcome

Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
Time frame: through study completion, an average of 16 weeks
Study success will be defined by an: improvement in gait speed of no less than 0,06 m/s as follows: H0: DT treatment phase - DT Sham phase < 0.06m/s v.s. Ha: DT treatment phase - DT Sham phase ≥ 0.06m/s Where: DT = VPost6 - VPre VPost 6= gait speed after 6 treatment stimulations (at the end of the treatment cycle) Vpre = gait speed before the 1st treatment stimulation (at the beginning of the treatment cycle)

4 secondary outcomes

Change in clinical evaluation in MDS-UPDRS
Time frame: through study completion, an average of 16 weeks
Change in clinical evaluation of step speed
Time frame: through study completion, an average of 16 weeks
Change in time in walking
Time frame: through study completion, an average of 16 weeks
Change in clinical evaluation in FOG-Q
Time frame: through study completion, an average of 16 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 10 Apr 2024.
Background: PubMed 20412722Semprini R, Sale P, Foti C, Fini M, Franceschini M. Gait impairment in neurological disorders: a new technological approach. Funct Neurol. 2009 Oct-Dec;24(4):179-83.
Background: PubMed 11748737Nieuwboer A, Dom R, De Weerdt W, Desloovere K, Fieuws S, Broens-Kaucsik E. Abnormalities of the spatiotemporal characteristics of gait at the onset of freezing in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1066-75. doi: 10.1002/mds.1206.
Results publication: PubMed 20946640Lo AC, Chang VC, Gianfrancesco MA, Friedman JH, Patterson TS, Benedicto DF. Reduction of freezing of gait in Parkinson's disease by repetitive robot-assisted treadmill training: a pilot study. J Neuroeng Rehabil. 2010 Oct 14;7:51. doi: 10.1186/1743-0003-7-51.
Derived from this study: PubMed 40200338De Pandis MF, Tomino C, Proietti S, Rotondo R, Gaglione M, Casali M, Corbo M, di Biase L, Galli M, Goffredo M, Stocchi F. Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson's disease: a multi-centre, double-blind, crossover randomized controlled trial. J Neuroeng Rehabil. 2025 Apr 8;22(1):77. doi: 10.1186/s12984-025-01574-3.
Individual participant dataSharing planned: Undecided

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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. PhD principal investigator

IRCCS San Raffaele

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AMPS Gondola in people with Parkinson Disease, run by IRCCS San Raffaele Roma 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 5 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 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 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?

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?

Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle (time frame: through study completion, an average of 16 weeks). 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 NCT03843268, which also lists 4 linked publications.

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.