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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Custom-made shoe insole
* Device: Sham conventional Insole


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custom-Made Insole<br>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<br>* 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.<br>|
| Sham Comparator: Sham Insole<br>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<br>* Subjects will receive a conventional insole without any specific property (sham insole)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 
| 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)) | Baseline, at 10 weeks, and at 16 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Foot Orthoses, Randomized controlled trial