Parkinson Disease(PD)NCT07281755
Objective Mobility Assessment Using Wearable Technology for Clinical Application in Parkinson's Disease: From Validation to Fall Prediction
An observational study of Parkinson Disease(PD), run by Northumbria University at 1 site in United Kingdom.
Trial summary
The main objective of this observational trial is to explore the validity and reliability of DANU smart socks when used for mobility assessments in people with Parkinson's. Using a series of laboratory gold standard equipment, this project aims to compare the metrics observed by DANU to the reference standards. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease(PD)
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Within laboratory testing, 60 people with Parkinson's (H\&Y I-III) are aimed to be recruited from the North East region of England.
Who may be able to join
- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria.
- Hoehn \& Yahr stages I-III
- Able to attend Northumbria University, Newcastle Upon Tyne for study visits
- Able to walk and stand unassisted for a minimum of 2-minutes
Who cannot join
- History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
- Montreal Cognitive Assessment (MoCA) score < 21
- Injury to the lower extremities within the past 6-weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Northumbria University
Newcastle upon Tyne
Gabriella R Gatti, BSc, 01912273343, gabriella.gatti@northumbria.ac.uk
Rodrigo Vitorio, PhD, 01912273343, rodrigo.vitorio@northumbria.ac.uk
About this study
The main objective of this observational trial is to explore the validity and reliability of DANU smart socks when used for mobility assessments in people with Parkinson's. Using a series of laboratory gold standard equipment, this project aims to compare the metrics observed by DANU to the reference standards. No intervention is included. Specifically, this study will explore metrics relating to walking (gait) and balance of a Parkinson's cohort through a series of motor tasks. Moreover, this study seeks to investigate the clinical validity of DANU outcome metrics exploring relationships with clinical scales, fall history and prospective falls.
Read the detailed description
Background:
Mobility impairments are common in Parkinson's disease (PD) and increase the risk of falling. Data derived from wearable inertial measurement units can provide useful information regarding gait in different situations and environments, which may help to identify those at risk of falling. However, rigorous testing is required to evaluate whether new devices are fit for purpose. DANU Smart Socks are a multi-modal system for movement analysis, containing 15 silicone based capacitive pressure sensors and an IMU pod, with tri-axal accelerometers, gyroscope and magnetometers, currently at use within a sporting context. Potential has been highlighted for clinical use in people with Parkinson's (PwP). This study aims to evaluate the validity, reliability and usability of the DANU Sport System in PwP for balance and gait assessment. The V3+ framework for determining fit-for-purpose biometric monitoring devices will be employed, evaluating verification, usability, analytical and clinical validation.
Methods:
Institutional ethics have been obtained (Project ID: 8543). Utilising a a repeated measures observational design, participants will be asked to attend two visits to Northumbria University, Newcastle Upon Tyne.
Visit 1: Participants will complete a series of clinical and cognitive measures including the Movement Disorders Society's-Unified Parkinson's Disease Rating Scale, Montreal Cognitive Assessment, Freezing of Gait Questionnaire and Falls Efficacy Scale. Following this, concurrent data collection will occur throughout a battery of motor tasks to observe gait/balance metrics. Laboratory references employed include Axivity AX6, Vicon 3D Motion Capture, APDM Mobility Lab, GAITRite and AMTI Force Plates. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.
Visit 2: Participants attend a second visit to repeat the mobility assessment previously detailed utilizing DANU Smart Socks and APDM Mobility Lab systems to explore test-retest reliability.
Wearable device (DANU) validity and reliability will be examined using intra-class correlation coefficients and Bland-Altman plots to compare to laboratory reference standards. Moreover time series plots will be employed to evaluate the raw data agreement.
- Conditions
- Parkinson Disease(PD)
- Keywords
- DANU, Wearable Electronic Devices, Gait Analysis, Validity and Reliability, Mobility Assessment, Smart Socks
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease (PD) | People with a clinical diagnosis of Parkinson's Disease will be recruited to participate within the study. All participants must fit within the described eligibility criteria. Within the verification and analytical validation phase 30 people with Parkinson's will be recruited and within clinical validation 60 individuals will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride Length
(m, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Step Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Stride Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Cadence
(steps per minute, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Ground Contact Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Swing Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Stride Velocity
(m/s, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Gait Velocity
(m/s, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Area of Ellipse
(mm², mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Length of Ellipse
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Width of Ellipse
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Total Displacement
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Medio-Lateral Range
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Anterior-Posterior Range
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start8 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease(PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- DANU Sports Ltd
- Responsible party
- Principal investigator, GabriellaGatti, Northumbria University
- Investigators
- Rodrigo Vitorio, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281755
- Sponsor's protocol ID
- 8543a
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Mobility Assessment Using Wearable Technology for Clinical Application in Parkinson's Disease: From Validation to Fall Prediction
- ClinicalTrials.gov ID
- NCT07281755
- Acronym / sponsor ID
- 8543a
- Conditions
- Parkinson Disease(PD)
- Keywords
- DANU, Wearable Electronic Devices, Gait Analysis, Validity and Reliability, Mobility Assessment, Smart Socks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- DANU Sports Ltd
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this observational trial is to explore the validity and reliability of DANU smart socks when used for mobility assessments in people with Parkinson's. Using a series of laboratory gold standard equipment, this project aims to compare the metrics observed by DANU to the reference standards. No intervention is included. Specifically, this study will explore metrics relating to walking (gait) and balance of a Parkinson's cohort through a series of motor tasks. Moreover, this study seeks to investigate the clinical validity of DANU outcome metrics exploring relationships with clinical scales, fall history and prospective falls.
Detailed description
Background:
Mobility impairments are common in Parkinson's disease (PD) and increase the risk of falling. Data derived from wearable inertial measurement units can provide useful information regarding gait in different situations and environments, which may help to identify those at risk of falling. However, rigorous testing is required to evaluate whether new devices are fit for purpose. DANU Smart Socks are a multi-modal system for movement analysis, containing 15 silicone based capacitive pressure sensors and an IMU pod, with tri-axal accelerometers, gyroscope and magnetometers, currently at use within a sporting context. Potential has been highlighted for clinical use in people with Parkinson's (PwP). This study aims to evaluate the validity, reliability and usability of the DANU Sport System in PwP for balance and gait assessment. The V3+ framework for determining fit-for-purpose biometric monitoring devices will be employed, evaluating verification, usability, analytical and clinical validation.
Methods:
Institutional ethics have been obtained (Project ID: 8543). Utilising a a repeated measures observational design, participants will be asked to attend two visits to Northumbria University, Newcastle Upon Tyne.
Visit 1: Participants will complete a series of clinical and cognitive measures including the Movement Disorders Society's-Unified Parkinson's Disease Rating Scale, Montreal Cognitive Assessment, Freezing of Gait Questionnaire and Falls Efficacy Scale. Following this, concurrent data collection will occur throughout a battery of motor tasks to observe gait/balance metrics. Laboratory references employed include Axivity AX6, Vicon 3D Motion Capture, APDM Mobility Lab, GAITRite and AMTI Force Plates. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.
Visit 2: Participants attend a second visit to repeat the mobility assessment previously detailed utilizing DANU Smart Socks and APDM Mobility Lab systems to explore test-retest reliability.
Wearable device (DANU) validity and reliability will be examined using intra-class correlation coefficients and Bland-Altman plots to compare to laboratory reference standards. Moreover time series plots will be employed to evaluate the raw data agreement.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (PD) | – | –People with a clinical diagnosis of Parkinson's Disease will be recruited to participate within the study. All participants must fit within the described eligibility criteria. Within the verification and analytical validation phase 30 people with Parkinson's will be recruited and within clinical validation 60 individuals will be recruited. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Within laboratory testing, 60 people with Parkinson's (H\&Y I-III) are aimed to be recruited from the North East region of England.
Key inclusion criteria (4 listed)
- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria.
- Hoehn \& Yahr stages I-III
- Able to attend Northumbria University, Newcastle Upon Tyne for study visits
- Able to walk and stand unassisted for a minimum of 2-minutes
Key exclusion criteria (3 listed)
- History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
- Montreal Cognitive Assessment (MoCA) score < 21
- Injury to the lower extremities within the past 6-weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stride Length
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(m, mean ± standard deviation)
Step Time
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Stride Time
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Cadence
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(steps per minute, mean ± standard deviation)
Ground Contact Time
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Swing Time
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Stride Velocity
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(m/s, mean ± standard deviation)
Gait Velocity
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(m/s, mean ± standard deviation)
Area of Ellipse
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm², mean ± standard deviation)
Length of Ellipse
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Width of Ellipse
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Total Displacement
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Medio-Lateral Range
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Anterior-Posterior Range
Time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- DANU Medical Website: Study Collaborator and Smart Sock System.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo Vitorio, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease(PD), run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella R Gatti, BSc (01912273343, gabriella.gatti@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride Length (time frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.