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

NCT04803565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-10-03

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Custom-made shoe insole

Subjects will receive a custom-made shoe insole designed on the patient's foot and shoes. The subjects should wear the insole for at least 6 hours per day.

DEVICE

Sham conventional Insole

Subjects will receive a conventional insole without any specific property (sham insole)

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2022-12-31
Completion
2023-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803565 on ClinicalTrials.gov