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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation

About this trial

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).

Eligibility criteria

Qualifiers

Diagnosis of Parkinson's disease, according to the clinical diagnostic criteria of the Movement Disorders Society (Postuma RB, 2015);

Hoehn & Yahr between II and IV;

Stable medical therapy since at least one month before enrollment

Disqualifiers

Concomitant diagnosis of other neurological or psychiatric disorders that may influence study assessments.;

MMSE score <24;

Patients with DBS implant or on DuoDopa therapy;

Presence of relevant musculoskeletal or orthopedic pathologies;

Trial design

Treatments tested in this trial

  • Greater plantar feedback shoes
  • Neutral gym shoes
  • Barefoot

Treatment groups

40 Participants
are divided into 3 treatment groups

Locations

This trial has no locations