NCT07308418

Brief Summary

The study tests whether a smart shoe (NUSHU) that provides vibrotactile stimulation can improve walking speed in people with Parkinson's disease. Sixteen participants complete two short walking tests-with and without vibration-to compare gait speed, cadence, stride length, usability, and safety. It is a low-risk pilot study meant to generate first evidence for future research.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

December 1, 2025

Last Update Submit

February 26, 2026

Conditions

Keywords

Parkinson's DiseaseGait analysisVibrotactile feedback

Outcome Measures

Primary Outcomes (2)

  • Change in self-selected walking speed (m/s)

    Change in self-selected walking speed (m/s), measured over a 2-minute walking test with and without stimulation by the NUSHU. Walking speed is measured in m/s as a continuous metric variable, which is an objective and established way of measuring walking speed. The calculation is performed by dividing the total distance covered by the time in seconds (120 seconds).

    Once during 120 seconds

  • Change in self-selected gait speed

    One visit of 45 minutes

Study Arms (1)

Vibrotactile feedback while walking

ACTIVE COMPARATOR
Device: Vibrotactile feedback during walking

Interventions

NUSHU smart shoes give real time gait feedback during walking.

Vibrotactile feedback while walking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A medically confirmed diagnosis of Parkinson's disease on the physiotherapy prescription.
  • Stable medication for at least four weeks (no change in dopaminergic therapy).
  • The ability to walk at least 200 metres without stopping.
  • Minimum age: 18 years
  • Sufficient knowledge of German to understand the study information and complete the questionnaires.
  • Written informed consent form

You may not qualify if:

  • Atypical or secondary Parkinsonism
  • Sensory disturbances in the feet (e.g. polyneuropathy).
  • Other neurological, orthopaedic or internal medical conditions that significantly affect walking
  • Cognitive impairments that interfere with understanding the study information or following instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magnes AG

Zurich, Canton of Zurich, 8005, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 29, 2025

Study Start

January 10, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations