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COMPLETEDNA

The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects

The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial

NCT04803565•Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

Summary

This study aims to assess the efficacy of custom-made shoe insoles, for subjects with Parkinson's Disease (PD). To do that, a sample of PD subjects has been randomly assigned to an intervention group that will receive the custom-made insoles or a control group that will receive a sham insole without any specific manufacturing. Both groups will receive Physiotherapy and Occupational Therapy according to PD rehabilitation guidelines. The principal outcome will be the Time Up\&Go test time, secondary outcomes 10 Meters Walking test speed, Berg Balance Scale score, SF12 score, and orthesis liking.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with Idiopathic Parkinson's Disease;
•Age \> 18 years;
•Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
•Subjects must be able to walk at least 10 meters independently with or without any walking aid.

Exclusion Criteria

•Not clinical stable subjects;
•SUbjects in OFF phase during the evaluations;
•Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
•Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italy

Key Dates

Start Date

March 4, 2021

Primary Completion Date

December 31, 2022

Completion Date

March 30, 2023

Last Updated

October 3, 2023

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Custom-made shoe insole

DEVICE

Sham conventional Insole

DEVICE

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients