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

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.

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.)