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Next generation gait analysis in the cloud for patients with Parkinson’s Disease – A feasibility study

Next generation gait analysis in the cloud for patients with NUSHU for patients with Parkinson’s Disease – A feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001006538
Enrollment
1
Registered
2024-08-20
Start date
2024-12-13
Completion date
2025-02-19
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We want to test smart shoes. We want to see if wearing these shoes decreases falls for people with Parkinson’s disease. We can monitor your walking at home when you wear these shoes. In this project we want to test a new way of obtaining objective measures of walking and falls risk in people with Parkinson’s Disease using novel technologies allowing continuous monitoring at home. For this pilot study we want to test the usefulness of such an approach using newly developed smart shoes (‘NUSHUs’, developed by our industry partner Magnes AG) with built-in sensors that study participants can use for walking or exercising at home. These shoes are not approved by the TGA in Australia. The shoes continuously record your mobility. The smart shoes collect data while you are walking or exercising and processes the data using advanced methods. During the study you will receive a training program tailored specifically to your individual needs to complete while wearing the smart shoes. The collected data can be accessed by the treating team so they can track your progress and guide you further via telehealth or in person reviews. By understanding how such a technique can be incorporated into clinical practice, this research will contribute to exploring modern management approaches for patients suffering from Parkinson’s Disease.

Interventions

Magnes Nushu is a smart shoe with embedded sensors and vibrotactile actuators, capable of real-time gait analysis and gait-driven haptic cueing. Magnes Nushu enables patients to collect data on their gait and share this data with healthcare professionals (HCPs). Data will be automatically uploaded via a mobile phone app linked to the smart shoes. Data will be available to the Research team in Princess Alexandra Hospital and Queensland University of Technology and the Magnes company who owns the

Magnes Nushu is a smart shoe with embedded sensors and vibrotactile actuators, capable of real-time gait analysis and gait-driven haptic cueing. Magnes Nushu enables patients to collect data on their gait and share this data with healthcare professionals (HCPs). Data will be automatically uploaded via a mobile phone app linked to the smart shoes. Data will be available to the Research team in Princess Alexandra Hospital and Queensland University of Technology and the Magnes company who owns the shoe. This non- identifiable data is accessible only if participant gives permission to access the data. Magnes Nushu has the potential to help patients with gait deficits by providing them notifications via vibrations on how they walk to assist normal walking. The vibration function will not be used in this study. The study is designed in three phases to align with our research objectives directly. The total study duration is 14 weeks, and it is separated into three phases. Duration of each study visits is 1-2 hours. Study participants will be provided with a diary by the study coordinator and asked to maintain the diary to record falls, NUSHU usage and physical activity at each study phase. Participants will be asked to provide this diary back to the study team at their next study visit. A study member will check in with participants weekly throughout the study to ensure participants are not having issues with using the investigational product and to enquire about any falls or other adverse events that may have occurred. Phase 1 (week 1-4): Observational phase: Patients will wear the NUSHUs at home while performing their everyday activities (min 1 hr/day). Phase 2 (week 5-10): Intervention phase: Patients will wear the NUSHU while conducting a Physiotherapy-prescribed daily home-exercise program targeting gait, balance and freezing of gait and while at home performing everyday activities (min 1 hr/day). Participants will undergo assessment by a Physiotherapist and will receive a tailored home-based exercise program for the subsequent six weeks (i.e., phase 2). The program, utilising evidence-based physical therapy practice will be developed by a Physiotherapist with experience in managing Parkinson's Disease across the disease progression. Exercise prescription will be tailored targeting falls prevention, freezing of gait and endurance. Participants will be supported and monitored through their home-based exercise program while wearing the NUSHUs Participants will be expected to complete NUSHU inbuilt assessments such as Timed Up and Go tests,10m walk test and tests of standing balance. We expect the exercises will take about 20 minutes per day. Completing of the exercises is being monitored through the NUSHUs and the NUHSU app. Participants will also be followed weekly via phone call during this period. Phase 3 (week 11-14): ‘Washout’ and monitoring phase: Patients will continue to wear the NUSHUs at home while performing their everyday activities (min 1 hr/day). If these participants have a caregiver, they will be invited to participate in the study. participant’s and caregiver’s acceptability of using this new technology of smart shoes as measured by their ratings at the exit survey.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults aged 18 years and over 2. Have received diagnosis of Parkinson’s Disease. 3. Able to read and write English. 4. Have access to an Apple iOS device with internet access 5. The participants will be required to wear the NUSHUs during home assessments. Participants will also be provided with a diary to record daily activity.

Exclusion criteria

1. Body weight of greater than or equal to 120kg

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026