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

Primary Purpose

Idiopathic Parkinson's Disease, Progressive Supranuclear Palsy

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Foot Mechanical Stimulation (GONDOLA)
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • San Raffaele Cassino
  • University Campus Biomedico of Rome
  • IRCCS San Raffaele Roma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Foot Mechanical Stimulation

Footh Mechanical Stimulation

Arm Description

The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
FREEZING OF GAIT QUESTIONNAIRES
THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)

Full Information

First Posted
March 14, 2013
Last Updated
September 30, 2022
Sponsor
IRCCS San Raffaele Roma
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1. Study Identification

Unique Protocol Identification Number
NCT01815281
Brief Title
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy.
Acronym
GONDOLAPILOTA
Official Title
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS San Raffaele Roma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease, Progressive Supranuclear Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foot Mechanical Stimulation
Arm Type
Experimental
Arm Description
The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Arm Title
Footh Mechanical Stimulation
Arm Type
Sham Comparator
Arm Description
The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Intervention Type
Device
Intervention Name(s)
Foot Mechanical Stimulation (GONDOLA)
Other Intervention Name(s)
GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Primary Outcome Measure Information:
Title
Timed Up and Go.
Description
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).
Time Frame
Change from Baseline in Timed Up and Go test at 1 month follow up.
Secondary Outcome Measure Information:
Title
6 minuts walking test.
Description
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).
Time Frame
Change from Baseline in gait speed at 1 month follow up
Title
Gait Parameters
Description
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).
Time Frame
Change from Baseline in Gait Parameters at 1 month follow up
Title
FREEZING OF GAIT QUESTIONNAIRES
Time Frame
Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
Title
THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)
Time Frame
Change from Baseline in PDQ-39 at 1 month follow up
Other Pre-specified Outcome Measures:
Title
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS).
Time Frame
Change from Baseline in UPDRS scores at 1 month follow up
Title
PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES)
Time Frame
Change from Baseline in PSP RATING SCALES scores at 1 month follow up
Title
Functional Ambulation classification (FAC)
Time Frame
Change from Baseline in FAC scores at 1 month follow up
Title
Walking handicap Scale (WHS)
Time Frame
Change from Baseline in WHS scores at 1 month follow up
Title
BOLD signal response to gondola treatment
Description
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).
Time Frame
Change from Baseline in UPDRS scores at 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi, MD
Organizational Affiliation
IRCCS San Raffaele Pisana Rome Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michela Goffredo, BME
Organizational Affiliation
IRCCS San Raffaele Pisana Rome Italy
Official's Role
Study Director
Facility Information:
Facility Name
San Raffaele Cassino
City
Cassino
State/Province
FR
Country
Italy
Facility Name
University Campus Biomedico of Rome
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
IRCCS San Raffaele Roma
City
Rome
ZIP/Postal Code
00163
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26469868
Citation
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.
Results Reference
derived

Learn more about this trial

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

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