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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi | Milan | 20148 | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham conventional Insole | Device | Subjects will receive a conventional insole without any specific property (sham insole) |
|
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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |