NUSHU smart shoes to record gait and provide vibrational cues for people with Parkinson's

Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls

This will test NUSHU sensor-equipped shoes that record walking patterns and give vibration cues to see if they help people with Parkinson's disease walk more steadily.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Weill Medical College of Cornell University (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06975059 on ClinicalTrials.gov

What this trial studies

Participants with Parkinson's disease will wear the NUSHU shoe, which contains sensors to collect detailed gait measurements and can deliver vibrational feedback during walking. Data will be gathered during clinic visits and likely during real-world ambulation to capture variability that short clinic exams miss. The device aims both to measure subtle gait changes and to provide cueing that may improve step timing or reduce freezing episodes. Eligible adults who can walk independently and tolerate the device will be enrolled at a single site.

Who should consider this trial

Good fit: Adults (≥18) with a diagnosis of Parkinson's disease who can walk independently, can wear the shoe, speak English, and provide informed consent are the ideal candidates.

Not a fit: People with atypical parkinsonism, other neurological or musculoskeletal conditions that significantly affect gait, inability to wear the device, or who cannot ambulate independently are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the shoes could help people with Parkinson's walk more steadily and may reduce freezing or fall risk by providing timely vibrational cues.

How similar studies have performed: Previous small studies of wearable cueing devices for Parkinson's have reported mixed but promising results for improving gait and reducing freezing in some patients.

Eligibility criteria

Parkinson's Disease:

Inclusion Criteria:

1. Male or female ≥ 18 years of age.
2. A diagnosis of Parkinson's disease
3. Able to give written informed consent (as determined by the investigator)
4. Can converse in English and read and perform all study activities
5. Has willingness and ability to comply with study requirements

Exclusion Criteria:

1. Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD
2. A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy
3. Persons with disorders other than PD significantly affecting gait as determined by the investigator
4. History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator
5. Inability to wear interventional device
6. Unable to ambulate independently at least with assistive walking device but without additional person assistance
7. Pregnant or planning pregnancy within study timeframe
8. Montreal Cognitive Assessment (MoCA) score \< 22 at screening
9. Resides in a nursing home or assisted care facility

Healthy Controls:

Inclusion Criteria:

1. Male or female ≥ 18 years of age.
2. No neurological disease or other significant gait impairment as deemed by the study investigator

Where this trial is running

New York, New York

• Weill Cornell — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Harini Sarva, MD — Weill Medical College of Cornell University
• Study coordinator: Harini Sarva, MD

Conditions Parkinson' s Disease