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

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Sham conventional Insole; Device: Custom-made shoe insole

Study type: Interventional

Funder types: Other

Identifiers

NCT04803565

JP-002

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Custom-Made Insole

Experimental group

Description:

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

Treatment:

Device: Custom-made shoe insole

Sham Insole

Sham Comparator group

Description:

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

Treatment:

Device: Sham conventional Insole