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Trial registered on ANZCTR


Registration number
ACTRN12624001006538
Ethics application status
Approved
Date submitted
8/07/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Next generation gait analysis in the cloud for patients with Parkinson’s Disease – A feasibility study
Scientific title
Next generation gait analysis in the cloud for patients with NUSHU for patients with Parkinson’s Disease – A feasibility study
Secondary ID [1] 312355 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 334134 0
Condition category
Condition code
Neurological 330807 330807 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328850 0
Treatment: Devices
Intervention code [2] 329060 0
Lifestyle
Comparator / control treatment
In this study the participants themselves act as a comparator. In phase 1 the observational stage the participants will wear the NUSHUs at home while performing their everyday activities (min 1 hr/day) baseline prior to participants wearing the smart shoes.
Control group
Active

Outcomes
Primary outcome [1] 338569 0
The primary outcome measure is participant’s acceptability of using this new technology of smart shoes as measured by their ratings at the exit survey.
Timepoint [1] 338569 0
Completion of the study (End of week 14 from intervention commencement)
Primary outcome [2] 338941 0
The primary outcome measure is caregiver’s acceptability of using this new technology of smart shoes as measured by their ratings at the exit survey.
Timepoint [2] 338941 0
Completion of the study (End of week 14 from intervention commencement)
Secondary outcome [1] 436479 0
1. Correlation of gait data acquired from NUSHUs during trial period with the formal assessment- MDS UPDRS done at baseline and at 10-week assessment.
Timepoint [1] 436479 0
Baseline (Pre-intervention) and at 10-week assessment(post-intervention commencement)
Secondary outcome [2] 436480 0
2. Comparison of formal gait/balance assessment at baseline and after having undergone Physiotherapy home-exercise program at 10-week assessment
Timepoint [2] 436480 0
Baseline and 10-week assessment(post-intervention commencement)
Secondary outcome [3] 436481 0
3. Comparison of quality-of-life assessments and falls questionnaires at baseline and after having undergone home-exercise program at 10-week assessment
Timepoint [3] 436481 0
Baseline and 10-week assessment(post-intervention commencement)
Secondary outcome [4] 437988 0
4. Correlation of Balance data acquired from NUSHUs during trial period with the formal assessment- Modified Falls and Efficacy Scale done at baseline and at 10-week assessment.(post-intervention commencement)
Timepoint [4] 437988 0
Baseline (Pre-intervention) and at 10-week assessment(post-intervention commencement)
Secondary outcome [5] 438522 0
5.Correlation of gait data acquired from NUSHUs during trial period with the formal assessment Freezing of Gait Questionnaire done at baseline and at 10-week assessment.
Timepoint [5] 438522 0
Baseline (Pre-intervention) and at 10-week assessment (post-intervention commencement)
Secondary outcome [6] 438523 0
6.Correlation of gait data acquired from NUSHUs during trial period with the formal assessment- Six-minute Walk test done at baseline and at 10-week assessment.
Timepoint [6] 438523 0
Baseline (Pre-intervention) and at 10-week assessment (post-intervention commencement)
Secondary outcome [7] 438524 0
7. Correlation of gait data acquired from NUSHUs during trial period with the formal assessment-Ten Metre Walk test done at baseline and at 10-week assessment.
Timepoint [7] 438524 0
Baseline (Pre-intervention) and at 10-week assessment (post-intervention commencement)
Secondary outcome [8] 438527 0
8.Correlation of Balance data acquired from NUSHUs during trial period with the formal assessments. Activities- Specific Balance done at baseline and at 10-week assessment (post-intervention) commencement)
Timepoint [8] 438527 0
Baseline (Pre-intervention) and at 10-week assessment (post-intervention commencement)
Secondary outcome [9] 438528 0
9.Correlation of Balance data acquired from NUSHUs during trial period with the formal assessment Hoehn and Yahr scale done at baseline and at 10-week assessment (post-intervention) commencement)
Timepoint [9] 438528 0
Baseline (Pre-intervention) and at 10-week assessment (post-intervention commencement)
Secondary outcome [10] 438529 0
10.Correlation of Balance data acquired from NUSHUs during trial period with the formal assessments MDS-UPDRS done at baseline and at 10-week assessment (post-intervention) commencement)
Timepoint [10] 438529 0
Baseline (Pre-intervention) and at 10-week assessment (Post-intervention commencement)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
19/02/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26699 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 42737 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 316763 0
Government body
Name [1] 316763 0
SERTA Grant- Metro South Health
Country [1] 316763 0
Australia
Funding source category [2] 316765 0
University
Name [2] 316765 0
SERTA Grant- Queensland University of Technology
Country [2] 316765 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 318975 0
None
Name [1] 318975 0
Address [1] 318975 0
Country [1] 318975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315531 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315531 0
https://metrosouth.health.qld.gov.au/research/about-us/hrec
Ethics committee country [1] 315531 0
Australia
Date submitted for ethics approval [1] 315531 0
02/06/2023
Approval date [1] 315531 0
06/06/2023
Ethics approval number [1] 315531 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134986 0
Dr Alexander Lehn
Address 134986 0
Princess Alexandra Hospital,199 Ipswich Road, Woolloongabba, QLD 4102
Country 134986 0
Australia
Phone 134986 0
+61 0731764246
Fax 134986 0
Email 134986 0
[email protected]
Contact person for public queries
Name 134987 0
Schible Treasa Kurian
Address 134987 0
Princess Alexandra Hospital,199 Ipswich Road, Woolloongabba, QLD 4102
Country 134987 0
Australia
Phone 134987 0
+61 0436447386
Fax 134987 0
Email 134987 0
[email protected]
Contact person for scientific queries
Name 134988 0
Professor Graham Kerr
Address 134988 0
Queensland University of Technology | Kelvin Grove, Brisbane, QLD 4059,
Country 134988 0
Australia
Phone 134988 0
+61 0731386303
Fax 134988 0
Email 134988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.