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

Parkinson Disease Clinical Trial

— InsolePD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803565
• Other study ID #: JP-002
• Status: Completed
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Custom-made shoe insole
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.
• Sham conventional Insole
Subjects will receive a conventional insole without any specific property (sham insole)

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.