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

NCT04803565 | Completed

• 1 other identifier: JP-002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson Disease; Foot Orthoses; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Time Up&Go test

  Change from Baseline (without insoles (T0) and with insoles (T1)) Time Up\&Go at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))

  Baseline, at 10 weeks, and at 16 weeks.

Secondary Outcomes (15)

• Change in 10 Meters walking test Speed

  Baseline, at 10 weeks, and at 16 weeks.

• Change in Berg Balance Scale Score

  Baseline, at 10 weeks, and at 16 weeks.

• Change in Short-Form12 score

  Baseline, at 10 weeks, and at 16 weeks.

• Change in Likert scale 4 points

  Baseline, at 10 weeks, and at 16 weeks.

• Change in 10 Meters Walking Test cadence

  Baseline, at 10 weeks, and at 16 weeks.

Study Arms (2)

Custom-Made Insole

EXPERIMENTAL

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

Device: Custom-made shoe insole

Sham Insole

SHAM COMPARATOR

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

Device: Sham conventional Insole

Interventions

Custom-made shoe insole 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.

Custom-Made Insole

Sham conventional Insole DEVICE

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

Sham Insole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 17, 2021
• Study Start: March 4, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

IT (1)