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

October 2, 2023 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20148
        • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Sham Comparator: 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
Device: Sham conventional Insole
Subjects will receive a conventional insole without any specific property (sham insole)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time Up&Go test
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 10 Meters walking test Speed
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) 10 Meters walking test speed at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Berg Balance Scale Score
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Berg Balance Scale score at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Short-Form12 score
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline Short-form 12 at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Likert scale 4 points
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline Short-form 12 at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test cadence
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test step length
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test step duration
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test stance phase
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test swing phase
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test single support phase
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in 10 Meters Walking Test double support phase
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Kinematic parameters of gait during 10 Meters Walking test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Time Up&Go test sit-to-stand time
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Temporal and kinematic parameters of Time Up&Go test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Time Up&Go test stand-to-sit time
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Temporal and kinematic parameters of Time Up&Go test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Time Up&Go test mid-turning time
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Temporal and kinematic parameters of Time Up&Go test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.
Change in Time Up&Go test end-turning time
Time Frame: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Temporal and kinematic parameters of Time Up&Go test at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Baseline, at 10 weeks, and at 16 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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