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

Not Applicable

Terminated

• Conditions: Idiopathic Parkinson's Disease; Progressive Supranuclear Palsy
• Interventions: Device: Foot Mechanical Stimulation (GONDOLA)

• Registration Number: NCT01815281
• Lead Sponsor: IRCCS San Raffaele Roma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Study Start: 2013-07
• Primary Completion: 2013-11
• Status Verified: 2015-03
• Study Completion: 2015-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Foot Mechanical Stimulation	Foot Mechanical Stimulation (GONDOLA)	The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Footh Mechanical Stimulation	Foot Mechanical Stimulation (GONDOLA)	The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
FREEZING OF GAIT QUESTIONNAIRES	Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
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).
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).
THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)	Change from Baseline in PDQ-39 at 1 month follow up

Trial Locations

Locations (3)

IRCCS San Raffaele Roma; 🇮🇹 Rome, Italy

San Raffaele Cassino; 🇮🇹 Cassino, FR, Italy

University Campus Biomedico of Rome; 🇮🇹 Rome, Italy