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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Greater plantar feedback shoes
Other interventionShoes providing enhanced plantar feedback
Neutral gym shoes
Other interventionRegular gym shoes
Barefoot
Other interventionFor the acute evaluation, barefoot will be considered as an active comparator for enhanced plantar feedback
Treatment groups
Trial outcomes
Primary outcomes
Harmonic Ratio (HR)
Comparison of HR (continuous variable without unit of measurement) between feedback shoes patients, Neutral Shoes patients and the Barefoot control condition.
Harmonic Ratio (HR)
Comparison of HR (continuous variable without unit of measurement) between feedback shoes patients, Neutral Shoes patients and the Barefoot control condition.
Secondary outcomes
Comparison of coefficient of variation in patients between Finger Shoes patients and Neutral Shoes patients.
A secondary outcome will be the difference in coefficient of variation in patients between feedback shoes patients and Neutral Shoes patients.
Comparison of Harmonic Ratio in patients between Finger Shoes patients and Neutral Shoes patients.
The primary outcome will be the difference in Multiscale entropy (MSE - continuous variable, without unit of measurement) between feedback shoes patients and Neutral Shoes patients.
Comparison of Multiscale entropy between Finger Shoes patients and Neutral Shoes patients.
A secondary outcome will be the difference in Harmonic Ratio in patients between feedback shoes patients and Neutral Shoes patients.
Comparison of recurrence quantification analysis between feedback shoes patients and Neutral Shoes patients.
The primary outcome will be the difference in recurrence quantification analysis (RQA - continuous variable, without unit of measurement) between feedback shoes patients and Neutral Shoes patients.
Locations
Sponsors and contacts
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