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

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Unknown status
CT.gov ID
NCT01815281
Collaborator
(none)
3
Locations
2
Arms
21
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Foot Mechanical Stimulation (GONDOLA)
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Anticipated Study Completion Date :
Apr 1, 2015

Arms and Interventions

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).

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Timed Up and Go. [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).

    Secondary Outcome Measures

    1. 6 minuts walking test. [Change from Baseline in gait speed at 1 month follow up]

      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).

    2. Gait Parameters [Change from Baseline in Gait Parameters at 1 month follow up]

      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).

    3. FREEZING OF GAIT QUESTIONNAIRES [Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.]

    4. THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) [Change from Baseline in PDQ-39 at 1 month follow up]

    Other Outcome Measures

    1. UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS). [Change from Baseline in UPDRS scores at 1 month follow up]

    2. PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES) [Change from Baseline in PSP RATING SCALES scores at 1 month follow up]

    3. Functional Ambulation classification (FAC) [Change from Baseline in FAC scores at 1 month follow up]

    4. Walking handicap Scale (WHS) [Change from Baseline in WHS scores at 1 month follow up]

    5. BOLD signal response to gondola treatment [Change from Baseline in UPDRS scores at 1 month follow up]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Raffaele Cassino Cassino (FR) Italy
    2 University Campus Biomedico of Rome Rome Italy 00128
    3 IRCCS San Raffaele Pisana Rome Italy 00163

    Sponsors and Collaborators

    • IRCCS San Raffaele

    Investigators

    • Study Chair: Fabrizio Stocchi, MD, IRCCS San Raffaele Pisana Rome Italy
    • Study Director: Patrizio Sale, MD, IRCCS San Raffaele Pisana Rome Italy
    • Principal Investigator: Fabrizio Stocchi, MD, IRCCS San Raffaele Pisana Rome Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patrizio Sale , MD, MD, IRCCS San Raffaele
    ClinicalTrials.gov Identifier:
    NCT01815281
    Other Study ID Numbers:
    • GONDOLAPILOTA
    First Posted:
    Mar 21, 2013
    Last Update Posted:
    Mar 17, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Parkinson Disease
    Supranuclear Palsy, Progressive

    Study Results

    No Results Posted as of Mar 17, 2015