Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:30 AM
Study NCT ID:
NCT07308418
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-selected walking speed (m/s)', 'timeFrame': 'Once during 120 seconds', 'description': '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).'}, {'measure': 'Change in self-selected gait speed', 'timeFrame': 'One visit of 45 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Gait analysis', 'Vibrotactile feedback'], 'conditions': ["Parkinson's Disease (PD)"]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Study Overview\n\nThis 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.\n\nRationale\n\nEarlier 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.\n\nParticipants\n\nSixteen 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.\n\nStudy Design and Procedures\n\nParticipants attend a single 45-minute session consisting of:\n\nInformed consent and eligibility assessment\n\nInstruction on NUSHU use\n\nTwo 2-minute walking tests (with and without vibration), in randomized order\n\nA 15-minute washout between tests\n\nCompletion of the System-Usability-Scale (SUS) questionnaire\n\nContinuous monitoring and documentation of safety events and perceived stability\n\nThe assessor is blinded regarding the stimulation condition to reduce bias.\n\nOutcomes\n\nPrimary outcome:\n\nDifference in self-selected gait speed between vibration vs. no-vibration conditions.\n\nSecondary outcomes:\n\n* Cadence\n* Stride length\n* Usability (SUS-DE)\n* Safety observations and subjective stability ratings\n\nStatistics 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.\n\nEthics \\& 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.\n\nPurpose:\n\n* Overall, the study aims to understand:\n* The short-term effect of vibrotactile stimulation on gait\n* The feasibility, usability, and safety of NUSHU in a PD population\n* Whether larger, controlled trials are justified"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* A medically confirmed diagnosis of Parkinson's disease on the physiotherapy prescription.\n* Stable medication for at least four weeks (no change in dopaminergic therapy).\n* The ability to walk at least 200 metres without stopping.\n* Minimum age: 18 years\n* Sufficient knowledge of German to understand the study information and complete the questionnaires.\n* Written informed consent form\n\nExclusion criteria:\n\n* Atypical or secondary Parkinsonism\n* Sensory disturbances in the feet (e.g. polyneuropathy).\n* Other neurological, orthopaedic or internal medical conditions that significantly affect walking\n* Cognitive impairments that interfere with understanding the study information or following instructions"}, 'identificationModule': {'nctId': 'NCT07308418', 'briefTitle': "The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Magnes AG'}, 'officialTitle': "The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease", 'orgStudyIdInfo': {'id': '2025-01560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vibrotactile feedback while walking', 'interventionNames': ['Device: Vibrotactile feedback during walking']}], 'interventions': [{'name': 'Vibrotactile feedback during walking', 'type': 'DEVICE', 'description': 'NUSHU smart shoes give real time gait feedback during walking.', 'armGroupLabels': ['Vibrotactile feedback while walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8005', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Romina Willi', 'role': 'CONTACT', 'email': 'research@magnes.ch', 'phone': '0442234873'}], 'facility': 'Magnes AG', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Romina Willi', 'role': 'CONTACT', 'email': 'research@magnes.ch', 'phone': '+41442234873'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magnes AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}