search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Custom-made shoe insole
Sham conventional Insole
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Foot Orthoses, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • IRCCS Fondazione Don Carlo Gnocchi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Custom-Made Insole

Sham Insole

Arm 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

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

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

Change in 10 Meters walking test Speed
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))
Change in Berg Balance Scale Score
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))
Change in Short-Form12 score
Change from Baseline Short-form 12 at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Change in Likert scale 4 points
Change from Baseline Short-form 12 at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Change in 10 Meters Walking Test cadence
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))
Change in 10 Meters Walking Test step length
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))
Change in 10 Meters Walking Test step duration
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))
Change in 10 Meters Walking Test stance phase
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))
Change in 10 Meters Walking Test swing phase
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))
Change in 10 Meters Walking Test single support phase
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))
Change in 10 Meters Walking Test double support phase
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))
Change in Time Up&Go test sit-to-stand time
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))
Change in Time Up&Go test stand-to-sit time
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))
Change in Time Up&Go test mid-turning time
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))
Change in Time Up&Go test end-turning time
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))

Full Information

First Posted
March 4, 2021
Last Updated
October 2, 2023
Sponsor
Fondazione Don Carlo Gnocchi Onlus
search

1. Study Identification

Unique Protocol Identification Number
NCT04803565
Brief Title
The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects
Acronym
InsolePD
Official Title
The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Foot Orthoses, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Custom-Made Insole
Arm Type
Experimental
Arm 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
Arm Title
Sham Insole
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Custom-made shoe insole
Intervention Description
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
Intervention Name(s)
Sham conventional Insole
Intervention Description
Subjects will receive a conventional insole without any specific property (sham insole)
Primary Outcome Measure Information:
Title
Change in Time Up&Go test
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Secondary Outcome Measure Information:
Title
Change in 10 Meters walking test Speed
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Berg Balance Scale Score
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Short-Form12 score
Description
Change from Baseline Short-form 12 at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Likert scale 4 points
Description
Change from Baseline Short-form 12 at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test cadence
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test step length
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test step duration
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test stance phase
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test swing phase
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test single support phase
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in 10 Meters Walking Test double support phase
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Time Up&Go test sit-to-stand time
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Time Up&Go test stand-to-sit time
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Time Up&Go test mid-turning time
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.
Title
Change in Time Up&Go test end-turning time
Description
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))
Time Frame
Baseline, at 10 weeks, and at 16 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Facility Information:
Facility Name
IRCCS Fondazione Don Carlo Gnocchi
City
Milan
ZIP/Postal Code
20148
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs