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

NCT ID: NCT04803565

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2023-03-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Custom-Made Insole

This Group will receive a custom-made shoe insole designed on the foot shape of the subjects.

The group will also receive Physiotherapy and Occupational Therapy according to current guidelines

Group Type: EXPERIMENTAL

Custom-made shoe insole

Intervention Type: DEVICE

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.

Sham Insole

This group will receive a Sham shoe insole without any specific custom-made design.

The group will also receive Physiotherapy and Occupational Therapy according to current guidelines

Group Type: SHAM_COMPARATOR

Sham conventional Insole

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham conventional Insole

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

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Milan, , Italy

Countries

Italy

Other Identifiers

JP-002

Identifier Type: -

Identifier Source: org_study_id