The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Device: Vibrotactile feedback during walking

Detailed Description

Study Overview

This monozentric, prospective within-subject crossover pilot study investigates whether vibrotactile stimulation provided by the NUSHU, a CE-certified smart shoe, can influence spatiotemporal gait parameters-primarily self-selected walking speed-in adults with Parkinson's disease (PD). Parkinson's disease is often associated with reduced gait speed, shorter strides, and altered cadence, all of which are clinically relevant because they correlate with morbidity, fall risk, and quality of life.

Rationale

Earlier research suggests that vibration can positively influence gait by modulating proprioception, but existing devices have been impractical or clinically cumbersome. The NUSHU integrates sensors and vibration modules into an everyday shoe, enabling precise, phase-specific stimulation during the swing phase. Since no previous PD studies have tested this device, the project seeks to assess feasibility, safety, and initial efficacy signals.

Participants

Sixteen adults with a confirmed Parkinson's diagnosis will be recruited from multiple Physiozentrum Zürich locations. Key inclusion requirements include stable medication, ability to walk ≥ 200 m without resting, and sufficient understanding of German. Exclusion criteria include neuropathy, atypical parkinsonism, major comorbid gait disorders, or cognitive impairment that may interfere with procedures.

Study Design and Procedures

Participants attend a single 45-minute session consisting of:

Informed consent and eligibility assessment

Instruction on NUSHU use

Two 2-minute walking tests (with and without vibration), in randomized order

A 15-minute washout between tests

Completion of the System-Usability-Scale (SUS) questionnaire

Continuous monitoring and documentation of safety events and perceived stability

The assessor is blinded regarding the stimulation condition to reduce bias.

Outcomes

Primary outcome:

Difference in self-selected gait speed between vibration vs. no-vibration conditions.

Secondary outcomes:

• Cadence
• Stride length
• Usability (SUS-DE)
• Safety observations and subjective stability ratings

Statistics As an exploratory pilot, the study is not powered for confirmatory conclusions. Paired statistical tests (t-test or Wilcoxon) will evaluate within-subject differences. Descriptive methods and Bonferroni-corrected secondary analyses will complement the primary evaluation.

Ethics & Risk Classified as Risk Category A, the study involves minimal risk, mainly the normal risk associated with walking. Strict inclusion criteria and supervised testing aim to reduce fall risk. Data will be pseudonymized and securely stored. Although participants receive no direct clinical benefit, the findings will support future research on technology-assisted mobility strategies for PD.

Purpose:

• Overall, the study aims to understand:
• The short-term effect of vibrotactile stimulation on gait
• The feasibility, usability, and safety of NUSHU in a PD population
• Whether larger, controlled trials are justified

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Romina Willi; Phone Number: +41442234873; Email: research@magnes.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8005
      • Recruiting
      • Magnes AG
      • Contact: Romina Willi; Phone Number: 0442234873; Email: research@magnes.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vibrotactile feedback while walking	Device: Vibrotactile feedback during walking; NUSHU smart shoes give real time gait feedback during walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Magnes AG

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Gait analysis; Vibrotactile feedback
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 2025-01560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No