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

NCT06453863 | Not Yet Recruiting

• 1 other identifier: Biofeedback Footwear Parkinson
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (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.

  Baseline, an average of 2 year

• Harmonic Ratio (HR)

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

  After intervention, an average of 2 year (T1)

Secondary Outcomes (11)

• Comparison of coefficient of variation in patients between Finger Shoes patients and Neutral Shoes patients.

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

• Comparison of Harmonic Ratio in patients between Finger Shoes patients and Neutral Shoes patients.

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

• Comparison of Multiscale entropy between Finger Shoes patients and Neutral Shoes patients.

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

• Comparison of recurrence quantification analysis between feedback shoes patients and Neutral Shoes patients.

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

• Comparison of normalized jerk score between Finger Shoes patients and Neutral Shoes patients.

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

Study Arms (3)

Barefoot

ACTIVE COMPARATOR

Participants will berform gait, postural and functional evaluations without wearing any shoes

Other: Barefoot

Neutral gym shoes

SHAM COMPARATOR

Participants will be provided with appropriately sized neutral gym shoes, both for the acute evaluations and for assessment of one month longitudinal changes

Other: Neutral gym shoes

Greater plantar feedback shoes

ACTIVE COMPARATOR

Participants will be provided with appropriately sized plantar shoes, both for the acute evaluations and for assessment of one month longitudinal changes

Other: Greater plantar feedback shoes

Interventions

Greater plantar feedback shoes OTHER

Shoes providing enhanced plantar feedback

Greater plantar feedback shoes

Neutral gym shoes OTHER

Regular gym shoes

Neutral gym shoes

Barefoot OTHER

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

Barefoot

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Presence of relevant internal or vascular pathologies.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Roberto MD De Icco

  IRCCS, Mondino Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto MD De Icco

CONTACT

+390382380425; roberto.deicco@mondino.it

Cinzia MD Fattore

CONTACT

+390382380385; cinzia.fattore@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06