Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
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.
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:
NCT07308418
Study Brief:
Protocol Section:
NCT07308418