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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
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.
Subjects will receive a conventional insole without any specific property (sham insole)
IRCCS Fondazione Don Carlo Gnocchi
Milan, Italy
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))
Time frame: Baseline, at 10 weeks, and at 16 weeks.
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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: 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))
Time frame: Baseline, at 10 weeks, and at 16 weeks.
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