Status:

COMPLETED

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

Lead Sponsor:

Fondazione Don Carlo Gnocchi Onlus

Conditions:

Parkinson Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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.)

Key Trial Info

Start Date :

March 4 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2023

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT04803565

Start Date

March 4 2021

End Date

March 30 2023

Last Update

October 3 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italy, 20148