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Completed

NCT Number: NCT04803565

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

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Sham conventional Insole

Device

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

Primary outcomes

  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 outcomes

  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))

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Acronym: InsolePD

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 17, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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