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Effects of Biofeedback Footwear in Parkinson's Disease: Assessment of Functional Motor Abilities and Locomotion

NCT06453863 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-13

No results posted yet for this study

Summary

The study aims to verify whether the use of a specific footwear providing increased plantar feedback (plantar feedback shoes) could improve gait parameters, postural control and functional performances in people with Parkinson's disease.

Specifically, the aims are:

* To evaluate the acute effect of plantar feedback shoes, by comparing gait, functional and postural performances in three conditions: neutral shoes, barefoot, and plantar feedback shoes;
* To evaluate the effect of four weeks of plantar feedback shoes, on gait, functional and postural performances.

Participants will undergo a comprehensive neurological examination, with administration of disease-specific scales (UPDRS III part 3, NFOG-q, LEDD, DASS-21). At each assessment the participants will perform an inertial gait analysis, a static posturography, and will undergo functional capacity assessments (TUG, 2MWT, 5-STST, 10- mFW).

Conditions

  • Parkinson Disease
  • Gait Disorders

Interventions

OTHER

Greater plantar feedback shoes

Shoes providing enhanced plantar feedback

OTHER

Neutral gym shoes

Regular gym shoes

OTHER

Barefoot

For the acute evaluation, barefoot will be considered as an active comparator for enhanced plantar feedback

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Roberto MD De Icco · IRCCS, Mondino Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-01-01
Completion
2025-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453863 on ClinicalTrials.gov