Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy. (GONDOLAPILOTA)

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.

Study Overview

• Status: Terminated
• Conditions: Progressive Supranuclear Palsy; Idiopathic Parkinson's Disease
• Intervention / Treatment: Device: Foot Mechanical Stimulation (GONDOLA)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00163
    • IRCCS San Raffaele Roma
  • Rome, Italy, 00128
    • University Campus Biomedico of Rome
  • FR
    • Cassino, FR, Italy
      • San Raffaele Cassino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Other significant neurological or orthopedic problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foot Mechanical Stimulation; The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).	Device: Foot Mechanical Stimulation (GONDOLA); Other Names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Sham Comparator: Footh Mechanical Stimulation; The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).	Device: Foot Mechanical Stimulation (GONDOLA); Other Names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from Baseline in Timed Up and Go test at 1 month follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Change from Baseline in Gait Parameters at 1 month follow up
FREEZING OF GAIT QUESTIONNAIRES		Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)		Change from Baseline in PDQ-39 at 1 month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS).		Change from Baseline in UPDRS scores at 1 month follow up
PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES)		Change from Baseline in PSP RATING SCALES scores at 1 month follow up
Functional Ambulation classification (FAC)		Change from Baseline in FAC scores at 1 month follow up
Walking handicap Scale (WHS)		Change from Baseline in WHS scores at 1 month follow up
BOLD signal response to gondola treatment	BOLD signal 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).	Change from Baseline in UPDRS scores at 1 month follow up

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Investigators: Principal Investigator: Fabrizio Stocchi, MD, IRCCS San Raffaele Pisana Rome Italy; Study Director: Michela Goffredo, BME, IRCCS San Raffaele Pisana Rome Italy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimated): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Parkinson Disease; Supranuclear Palsy, Progressive
• Other Study ID Numbers: RP 12/13