Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06975059
Status
Recruiting
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Conditions

  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • NUSHU shoe — DEVICE
    The NUSHU shoe, created by Magnes AG, can measure real-time detection of gait analysis while providing vibrotactile stimulus to the study participant through machine learning sensors. This may provide a feedback mechanism that acts as therapy for gait difficulties.

Study Details

Gait changes in Parkinson's disease are complex, variable, and difficult to detect during short clinic assessments. The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally provides vibrational feedback that can potentially help gait difficulties experienced by Parkinson's patients.

Key Dates

Start date
May 30, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Parkinson's Disease (Early)
    The early PD group will be those within 3 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
  • Experimental: Parkinson's Disease (Moderate)
    The moderate PD group will be those with 4-7 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
  • Experimental: Parkinson's Disease (Advanced)
    The advanced PD group will be those with at least 8 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
  • Active Comparator: Healthy Controls
    Healthy controls will include those without any neurological disease or other significant gait impairment. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.

Primary Outcome Measure

Mean Score of Comfort Level of Device in Satisfaction Survey [ Time Frame: At Safety Follow Up (Week 18) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill CornellNew YorkNew York10021
Principal Investigator, MD
[email protected]
212-746-1685
Clinical Research Coordinator
[email protected]
212-746-1685

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By research site
Weill Cornell· New York, NY

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