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

Progressive Supranuclear Palsy Clinical Trial

— GONDOLAPILOTA  

Official title:

Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01815281
• Other study ID #: RP 12/13
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2015
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Device:
• Foot Mechanical Stimulation (GONDOLA)

Locations

Country	Name	City	State
Italy	San Raffaele Cassino	Cassino	FR
Italy	IRCCS San Raffaele Roma	Rome
Italy	University Campus Biomedico of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS).		Change from Baseline in UPDRS scores at 1 month follow up
Other	PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES)		Change from Baseline in PSP RATING SCALES scores at 1 month follow up
Other	Functional Ambulation classification (FAC)		Change from Baseline in FAC scores at 1 month follow up
Other	Walking handicap Scale (WHS)		Change from Baseline in WHS scores at 1 month follow up
Other	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
Primary	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	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
Secondary	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
Secondary	FREEZING OF GAIT QUESTIONNAIRES		Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
Secondary	THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)		Change from Baseline in PDQ-39 at 1 month follow up