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

This study is not yet open for participant recruitment.
Verified March 2013 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Patrizio Sale , MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01815281
First received: March 14, 2013
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Idiopathic Parkinson's Disease
Progressive Supranuclear Palsy
 Device: Foot Mechanical Stimulation (GONDOLA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Timed Up and Go. [ Time Frame: Change from Baseline in Timed Up and Go test at 1 month follow up. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Change from Baseline in gait speed at 1 month follow up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Change from Baseline in Gait Parameters at 1 month follow up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up. ] [ Designated as safety issue: Yes ]
  • THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) [ Time Frame: Change from Baseline in PDQ-39 at 1 month follow up ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS). [ Time Frame: Change from Baseline in UPDRS scores at 1 month follow up ] [ Designated as safety issue: Yes ]
  • PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES) [ Time Frame: Change from Baseline in PSP RATING SCALES scores at 1 month follow up ] [ Designated as safety issue: Yes ]
  • Functional Ambulation classification (FAC) [ Time Frame: Change from Baseline in FAC scores at 1 month follow up ] [ Designated as safety issue: Yes ]
  • Walking handicap Scale (WHS) [ Time Frame: Change from Baseline in WHS scores at 1 month follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815281

Locations
Italy
San Raffaele Cassino Not yet recruiting
Cassino (FR), Italy
Contact: Maria Francesca De Pandis, MD            
Principal Investigator: Francesca De Pandis, MD            
Sub-Investigator: Patrizio Sale, MD            
IRCCS San Raffaele Pisana Active, not recruiting
Rome, Italy, 00163
Humanitas Clinical and Research Center Not yet recruiting
Rozzano, Italy
Contact: Raffaello Furlan, MD            
Contact: Franca Barbic, MD            
Principal Investigator: Raffaello Furlan, MD            
Sub-Investigator: Franca Barbic, MD            
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
  More Information

No publications provided

Responsible Party: Patrizio Sale , MD, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01815281     History of Changes
Other Study ID Numbers: GONDOPARK
Study First Received: March 14, 2013
Last Updated: March 20, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Paralysis
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Neurodegenerative Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013