CClinicalTrials.gg
Sign In
CompletedNCT04803565InsolePDUpdated Oct 3, 2023

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

An interventional study of Custom-made shoe insole and Sham conventional Insole in Parkinson Disease, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

Browse trials for

Keywords

  • Parkinson Disease
  • Foot Orthoses
  • Randomized controlled trial
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 42 is close to the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceCustom-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.

  • DeviceSham conventional Insole

    Subjects will receive a conventional insole without any specific property (sham insole)

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

07

Study locations

1 site
  • IRCCS Fondazione Don Carlo Gnocchi
    Milan, 20148, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04803565
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Responsible party
Sponsor
First posted
Mar 17, 2021
Start date
Mar 4, 2021
Primary completion
Dec 31, 2022
Completion
Mar 30, 2023
Last update
Oct 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Parkinson Disease→

Other studies from this sponsor

Fondazione Don Carlo Gnocchi Onlus

Start the discussion