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

NCT ID: NCT07308418

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-05-31

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

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease; Gait analysis; Vibrotactile feedback

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vibrotactile feedback while walking

Group Type: ACTIVE_COMPARATOR

Vibrotactile feedback during walking

Intervention Type: DEVICE

NUSHU smart shoes give real time gait feedback during walking.

Interventions

Vibrotactile feedback during walking

NUSHU smart shoes give real time gait feedback during walking.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magnes AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Romina Willi

Role: CONTACT

Phone: +41442234873

Email: research@magnes.ch

Other Identifiers

2025-01560

Identifier Type: -

Identifier Source: org_study_id