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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Custom-made shoe insole; Device: Sham conventional Insole

• Registration Number: NCT04803565
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-17
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom-Made Insole	Custom-made shoe 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
Sham Insole	Sham conventional 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

Primary Outcome Measures

Name	Time	Method
Change in Time Up&Go test	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))

Secondary Outcome Measures

Name	Time	Method
Change in 10 Meters Walking Test cadence	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))
Change in Time Up&Go test sit-to-stand time	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))
Change in Time Up&Go test mid-turning time	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))
Change in 10 Meters Walking Test stance phase	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))
Change in 10 Meters Walking Test double support phase	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))
Change in Short-Form12 score	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))
Change in Time Up&Go test stand-to-sit time	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))
Change in 10 Meters walking test Speed	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))
Change in Berg Balance Scale Score	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))
Change in Likert scale 4 points	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))
Change in 10 Meters Walking Test step length	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))
Change in 10 Meters Walking Test step duration	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))
Change in 10 Meters Walking Test swing phase	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))
Change in 10 Meters Walking Test single support phase	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))
Change in Time Up&Go test end-turning time	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))

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Milan, Italy