Stochastic Resonance Stimulation Effect on Gait Stability in Parkinson Disease

Not Applicable

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT06829342
• Lead Sponsor: University of Delaware

Brief Summary

The present study explored the use of a technique called stochastic resonance (SR) stimulation that may help individuals with Parkinson Disease maintain balance while walking on challenging surfaces. Impaired balance represents one of the disease symptoms, putting people at risk for falls, partly due to impaired processing of sensory information. SR uses light electrical signals to improve the way the body detects sensations. We wanted to test if SR could help people with Parkinson disease stay steadier while walking. Each participant's optimal SR intensity was determined before they walked on a treadmill in a virtual environment that created visual disturbances to challenge their balance. We measured how much their body swayed, how they placed their feet, and how their ankles moved during the walking tasks.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-19
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Clinical diagnosis of Parkinson Disease
• Hoehn and Yahr (H&Y) stage ≤ III
• Can walk independently for at least 2 minutes without an assistive device or orthosis
• Ability to communicate discomfort during testing
• Can follow multi-step commands
• Scored at least 24/30 on the Montreal Cognitive assessment (MoCA)

Exclusion Criteria

• Any head, neck, or face injury in the six months prior to the study (e.g., concussion, eye injury)
• History of vestibular or ocular dysfunction
• Currently taking any medications affecting balance (i.e. antibiotics)
• Injuries to lower extremities affecting balance in the past six months
• Pregnancy
• Any neurological disorders other than Parkinson's disease (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
• Unstable cardiac or pulmonary disease
• Clinically obese (BMI 30 or above)
• Any metal implant in the feet or legs that is close to the stimulating electrodes
• A known allergy to medical-grade adhesives
• Any other comorbidity affecting the ability to safely walk without assistance for at least 2 minutes
• Exhibited severe dyskinesia
• Did not respond to L-DOPA or other dopaminergic treatment
• Exhibited cardiovascular-autonomic or multiple-system symptoms indicative of a "Parkinsonism-plus" presentation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in the Center of Mass (CoM) excursion	Through study completion, an average of 1 year.	For the visual perturbation trials, we will use CoM excursion as the primary outcome measure since it has been used in prior studies in children and adults using visual perturbation protocols. This is determined by comparing the average CoM during perturbed steps to non-perturbed steps for each participant, integrated across the first eight steps initiated by the heel strike that triggered the stimulus. We will measure CoM using kinetics and kinematic computed through a motion capture system(Qualysis).; For the unperturbed trials, we will use margin of stability (MoS) as the primary outcome measure. MOS refers to the distance between extrapolated center of mass, which includes center of mass position and velocity, and the base of support. It has been previously used to measure balance in children with cerebral palsy and Parkinson Disease.

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States