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

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ClinicalTrials.gov Identifier: NCT04803565
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Custom-made shoe insole Device: Sham conventional Insole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Custom-Made 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

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 Comparator: Sham 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

Device: Sham conventional Insole
Subjects will receive a conventional insole without any specific property (sham insole)




Primary Outcome Measures :
  1. Change in Time Up&Go test [ Time Frame: 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 :
  1. Change in 10 Meters walking test Speed [ Time Frame: 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))

  2. Change in Berg Balance Scale Score [ Time Frame: 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))

  3. Change in Short-Form12 score [ Time Frame: 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))

  4. Change in Likert scale 4 points [ Time Frame: 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))

  5. Change in 10 Meters Walking Test cadence [ Time Frame: 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))

  6. Change in 10 Meters Walking Test step length [ Time Frame: 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))

  7. Change in 10 Meters Walking Test step duration [ Time Frame: 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))

  8. Change in 10 Meters Walking Test stance phase [ Time Frame: 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))

  9. Change in 10 Meters Walking Test swing phase [ Time Frame: 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))

  10. Change in 10 Meters Walking Test single support phase [ Time Frame: 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))

  11. Change in 10 Meters Walking Test double support phase [ Time Frame: 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))

  12. Change in Time Up&Go test sit-to-stand time [ Time Frame: 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))

  13. Change in Time Up&Go test stand-to-sit time [ Time Frame: 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))

  14. Change in Time Up&Go test mid-turning time [ Time Frame: 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))

  15. Change in Time Up&Go test end-turning time [ Time Frame: 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))



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803565


Contacts
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Contact: Joel Pollet, PT +393470439505 jpollet@dongnocchi.it

Locations
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Italy
IRCCS Fondazione Don Carlo Gnocchi Recruiting
Milan, Italy, 20148
Contact: Joel Pollet, PT    +39 3470439505    jpollet@dongnocchi.it   
Principal Investigator: Joel Pollet, PT         
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
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Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT04803565    
Other Study ID Numbers: JP-002
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
Parkinson Disease
Foot Orthoses
Randomized controlled trial
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases