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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Greater plantar feedback shoes

    Other intervention

    Shoes providing enhanced plantar feedback

  • Neutral gym shoes

    Other intervention

    Regular gym shoes

  • Barefoot

    Other intervention

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

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: BarefootActive comparator 1 intervention
Group B: Neutral gym shoesSham comparator 1 intervention
Group C: Greater plantar feedback shoesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Harmonic Ratio (HR)

Comparison of HR (continuous variable without unit of measurement) between feedback shoes patients, Neutral Shoes patients and the Barefoot control condition.

Time frame
Baseline, an average of 2 year
2

Harmonic Ratio (HR)

Comparison of HR (continuous variable without unit of measurement) between feedback shoes patients, Neutral Shoes patients and the Barefoot control condition.

Time frame
After intervention, an average of 2 year (T1)

Secondary outcomes

1

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.

Time frame
Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.
2

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.

Time frame
Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.
3

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.

Time frame
Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.
4

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.

Time frame
Double evaluation at baseline (T0) and four weeks after intervention (T1), an average of 2 year.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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