Parkinson Disease (PD)NCT07281794
Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
An observational study of Parkinson Disease (PD) and Healthy (Controls), run by Northumbria University at 2 sites in United Kingdom.
Trial summary
This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD), Healthy (Controls)
- How many people
- 60 participants
- Where
- 2 sitesUnited 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited if they fulfill the exclaimed participation criteria and are located within the North East of England. Participants will be recruited from our existing laboratory database, word of mouth and through visiting local groups.
Parkinson's Group Inclusion Criteria:- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria.
- PD stages I-III (Hoehn and Yahr Rating Scale)
- Able to attend Northumbria University, Newcastle Upon Tyne for study visits.
- Able to walk and stand unassisted for a minimum of 2-minutes.
- Aged 50 years old or over
Parkinson's Group Exclusion Criteria:
- History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
- Unable to walk or stand unaided.
- Montreal Cognitive Assessment (MoCA) score < 21
- Significant issues unrelated to PD that may affect gait (e.g., musculoskeletal issues, back pain, recent surgery etc.)
Healthy Control Inclusion Criteria:
- Ability to attend Northumbria University, Newcastle Upon Tyne for study visits.
- Aged 50 years old or over.
- Able to walk and stand unassisted for a minimum of 2-minutes.
Healthy Control Exclusion Criteria:
- History of neurological disorders (e.g. Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
- Significant issues that may affect walking (e.g., musculoskeletal issues, back pain, recent surgery etc.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Northumbria University
Newcastle upon Tyne, Tyne and Wear
Gabriella Gatti, BSc, 01912156078, gabriella.gatti@northumbria.ac.uk
Rodrigo Vitorio, PhD, 01912156078
- Enrolling by invitation
Northumbria University
Newcastle upon Tyne
About this study
This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.
Read the detailed description
Methods:
Institutional ethics have been obtained (Project ID: 8543). Utilising an observational design, participants will be asked to attend one visit 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 to act as descriptive measures. Following this, the investigators will conduct a concurrent data collection throughout a battery of motor tasks. The DANU system will be used alongside APDM Mobility Lab throughout the full duration of data collection. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.
- Conditions
- Parkinson Disease (PD), Healthy (Controls)
- Keywords
- DANU, Clinical Validation, Wearable Electronic Devices
- 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) | Participants with a clinical diagnosis of Parkinson's Disease meeting the described eligibility criteria will be recruited to take part within this study. The aim is to recruit 60 people with Parkinson's. | |
| Healthy Control (HC) | Aged-matched (over 50 years old) healthy controls who meet the described eligibility criteria will be recruited to participate in this study. The aim is to recruit 60 participants. |
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 in one visit (Day 1).
Step Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Stride Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Cadence
(steps per minute, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Ground Contact Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Swing Time
(s, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Stride Velocity
(m/s, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Gait Velocity
(m/s, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Area of Ellipse
(mm², mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Length of Ellipse
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Width of Ellipse
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Total Displacement
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Medio-Lateral Range
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
Anterior-Posterior Range
(mm, mean ± standard deviation)
Measured: Outcomes will be obtained in one visit (Day 1).
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
- Case-control
- 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
- NCT07281794
- Sponsor's protocol ID
- 8543b
- 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
- Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07281794
- Acronym / sponsor ID
- 8543b
- Conditions
- Parkinson Disease (PD), Healthy (Controls)
- Keywords
- DANU, Clinical Validation, Wearable Electronic Devices
- 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.
This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.
Detailed description
Methods:
Institutional ethics have been obtained (Project ID: 8543). Utilising an observational design, participants will be asked to attend one visit 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 to act as descriptive measures. Following this, the investigators will conduct a concurrent data collection throughout a battery of motor tasks. The DANU system will be used alongside APDM Mobility Lab throughout the full duration of data collection. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (PD) | – | –Participants with a clinical diagnosis of Parkinson's Disease meeting the described eligibility criteria will be recruited to take part within this study. The aim is to recruit 60 people with Parkinson's. |
| Healthy Control (HC) | – | –Aged-matched (over 50 years old) healthy controls who meet the described eligibility criteria will be recruited to participate in this study. The aim is to recruit 60 participants. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited if they fulfill the exclaimed participation criteria and are located within the North East of England. Participants will be recruited from our existing laboratory database, word of mouth and through visiting local groups.
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 in one visit (Day 1).
(m, mean ± standard deviation)
Step Time
Time frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Stride Time
Time frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Cadence
Time frame: Outcomes will be obtained in one visit (Day 1).
(steps per minute, mean ± standard deviation)
Ground Contact Time
Time frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Swing Time
Time frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Stride Velocity
Time frame: Outcomes will be obtained in one visit (Day 1).
(m/s, mean ± standard deviation)
Gait Velocity
Time frame: Outcomes will be obtained in one visit (Day 1).
(m/s, mean ± standard deviation)
Area of Ellipse
Time frame: Outcomes will be obtained in one visit (Day 1).
(mm², mean ± standard deviation)
Length of Ellipse
Time frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Width of Ellipse
Time frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Total Displacement
Time frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Medio-Lateral Range
Time frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Anterior-Posterior Range
Time frame: Outcomes will be obtained in one visit (Day 1).
(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
2 sites 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) and Healthy (Controls), run by Northumbria University at 2 sites 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?
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 2 sites 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 in one visit (Day 1).). 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.