Movement DisordersNCT05251701
Personal KinetiGraph® Clinical Validation Study
An observational study of Movement Disorders and Parkinson Disease, run by Global Kinetics Corporation at 1 site in United States.
Trial summary
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders, Parkinson Disease
- What is being tested?
- Personal KinetiGraph® (PKG®) System
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2022to 3 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be identified from routine clinical care
Who may be able to join
- Able and willing to sign a written informed consent for study participation
- Existing diagnosis of a movement disorder or a healthy control subject without diagnosis of a movement disorder
Who cannot join
- Bedridden, wheelchair confined, or requires the regular use of an assistive gait device (e.g., walker, cane, etc.)
- Occupation that involves repetitive movement or complete immobility (e.g., janitor, construction, or sedentary with no/limited arm movements such as a taxi driver)
- In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to complete the required PKG watch wear (e.g., subject unable to complete PKG wear instructions per Patient Instruction Manual), complete required assessments or interfere with data collection.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
Read the detailed description
This is a prospective, observational research study of the Personal KinetiGraph (PKG) System. The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. This study aims to clinically validate new PKG assessments such as walking, Device Assisted Therapy readiness, Percent Time Bradykinesia, Percent Time Dyskinesia, fall prediction, disease progression and non-motor. The clinical validation will require enrollment of both subjects with a diagnosis of movement disorder, such as Parkinson's disease, and healthy control subjects who do not a neurological disorder.
- Conditions
- Movement Disorders, Parkinson Disease
- Being tested
- Personal KinetiGraph® (PKG®) System
- Medical subject headings
- Movement Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal KinetiGraph® (PKG®) SystemDevice
The PKG® System includes a wrist-worn device that records and measures movement patterns in conditions such as Parkinson's disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch
The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
Measured: 2-3 years
Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch
For this outcome, patients may be classified as Device Assisted Therapy (DAT) criteria positive or criteria negative. DAT readiness may be evaluated using the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. PKG measurements may be compared to the patient's clinical characteristics and MDS-UPDRS scores.
Measured: 2-3 years
Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Measured: 2-3 years
Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Measured: 2-3 years
Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch
PKG measurements may be compared to data collected from freezing of gait questionnaire (FOG-Q) and posture analysis. The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4. Higher scores indicates more severe freezing of gait. Step count performance may also be used to evaluate fall prediction. The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
Measured: 2-3 years
Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch
Disease progression may be evaluated by predicting the levodopa response using severity levels of the Bradykinesia Score (BKS) and early morning Bradykinesia. Changes in PKG measurements may be compared to the MDS-UPDRS which evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms.
Measured: 2-3 years
Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales
PKG system data may be compared to non-motor assessments such as the non-motor questionnaire (NMSQ). The NMSQ includes questions regarding non-motor symptoms such as difficulty swallowing, constipation, difficulty sleeping, cognition, mood. Higher scores indicate more non-motor symptoms.
Measured: 2-3 years
Secondary outcomes (11)
Evaluation of PKG scores to assess differences by age category
PKG measurements will be recorded and compared across age ranges (40-90 years old as defined in the Inclusion Criteria) for subjects enrolled. Age categories from 40-59 years old, 60-79 years old and 80-90 years old will be evaluated.
Measured: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale
The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms.
Measured: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39)
The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Measured: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q)
The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4. Higher scores indicates more severe freezing of gait.
Measured: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS)
TETRAS assesses essential tremor severity and its impact on activities of daily living (ADL). The ADL section includes 12 items and the performance section includes 9. Each item is rated 0-4. Higher scores indicate more severe impacts of ADL and tremor.
Measured: 2-3 years
To compare PKG scores to subject diaries
Subject diaries will include recordings of medication times, falls, symptoms and sleep.
Measured: 2-3 years
To compare PKG scores to non-motor assessments such as the Non-Motor Symptoms Questionnaire (NMSQ)
The NMSQ includes 30 questions, answered either yes or no, and assesses the presence, not severity, of non-motor symptoms.
Measured: 2-3 years
To compare PKG scores to sleep assessments such as Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS)
The ESS includes 8 questions each scored from 0-3 with a maximum score of 24. The higher the ESS score, the higher that person's average sleep propensity or 'daytime sleepiness'.
The PDSS includes 15 questions, each rated from 0 to 10, with 0 being "Awful" or "Always" and 10 being "Excellent" or "Never".
Measured: 2-3 years
To compare PKG scores to the Montreal Cognitive Assessment (MoCA)
The MoCA is an assessment used for detecting cognitive impairment. The scores range from 0 to 30 with 0 being the lowest and 30 being the highest.
Measured: 2-3 years
To compare PKG scores to quality of life measurements such as EuroQual 5-D (EQ-5D)
The EQ-5D assesses health-related quality of life. Each question is scored from either 1-3 or 1-5, with 1 indicating no problems and 3 or 5 indicating extreme problems.
Measured: 2-3 years
To evaluate product usability and satisfaction for PKG Watch, docking station and PKG Portal
PKG product usability and satisfaction questionnaires will be used to evaluate this outcome. Responses to questions range from very difficult to very easy, strongly disagree to strongly agree, very uncomfortable to very comfortable.
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start9 Dec 2022
- Primary completion16 Aug 2023
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies 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
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Kinetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zoltan Mari, MD, Principal investigator, Z Neurosciences, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251701
- Sponsor's protocol ID
- Study 006
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2021
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Any clinical study IPD may be made available to other researchers including PKG data; demographics, such as age, gender, ethnicity; medical history, such as comorbid conditions and movement disorder history. Subject data will not include any personally identifiable information.
Publications
Griffiths RI, Kotschet K, Arfon S, Xu ZM, Johnson W, Drago J, Evans A, Kempster P, Raghav S, Horne MK. Automated assessment of bradykinesia and dyskinesia in Parkinson's disease. J Parkinsons Dis. 2012;2(1):47-55. doi: 10.3233/JPD-2012-11071.
PubMed 23939408Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
PubMed 25928634Kotschet K, Johnson W, McGregor S, Kettlewell J, Kyoong A, O'Driscoll DM, Turton AR, Griffiths RI, Horne MK. Daytime sleep in Parkinson's disease measured by episodes of immobility. Parkinsonism Relat Disord. 2014 Jun;20(6):578-83. doi: 10.1016/j.parkreldis.2014.02.011. Epub 2014 Feb 24.
PubMed 24674770Braybrook M, O'Connor S, Churchward P, Perera T, Farzanehfar P, Horne M. An Ambulatory Tremor Score for Parkinson's Disease. J Parkinsons Dis. 2016 Oct 19;6(4):723-731. doi: 10.3233/JPD-160898.
PubMed 27589540
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal KinetiGraph® Clinical Validation Study
- ClinicalTrials.gov ID
- NCT05251701
- Acronym / sponsor ID
- Study 006
- Conditions
- Movement Disorders, Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Global Kinetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 23 Feb 2022 (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 purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
Detailed description
This is a prospective, observational research study of the Personal KinetiGraph (PKG) System. The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. This study aims to clinically validate new PKG assessments such as walking, Device Assisted Therapy readiness, Percent Time Bradykinesia, Percent Time Dyskinesia, fall prediction, disease progression and non-motor. The clinical validation will require enrollment of both subjects with a diagnosis of movement disorder, such as Parkinson's disease, and healthy control subjects who do not a neurological disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be identified from routine clinical care
Key inclusion criteria (2 listed)
- Able and willing to sign a written informed consent for study participation
- Existing diagnosis of a movement disorder or a healthy control subject without diagnosis of a movement disorder
Key exclusion criteria (3 listed)
- Bedridden, wheelchair confined, or requires the regular use of an assistive gait device (e.g., walker, cane, etc.)
- Occupation that involves repetitive movement or complete immobility (e.g., janitor, construction, or sedentary with no/limited arm movements such as a taxi driver)
- In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to complete the required PKG watch wear (e.g., subject unable to complete PKG wear instructions per Patient Instruction Manual), complete required assessments or interfere with data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal KinetiGraph® (PKG®) SystemThe PKG® System includes a wrist-worn device that records and measures movement patterns in conditions such as Parkinson's disease. | Device | – |
Primary outcome
Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch
Time frame: 2-3 years
The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch
Time frame: 2-3 years
For this outcome, patients may be classified as Device Assisted Therapy (DAT) criteria positive or criteria negative. DAT readiness may be evaluated using the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. PKG measurements may be compared to the patient's clinical characteristics and MDS-UPDRS scores.
Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)
Time frame: 2-3 years
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch
Time frame: 2-3 years
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch
Time frame: 2-3 years
PKG measurements may be compared to data collected from freezing of gait questionnaire (FOG-Q) and posture analysis. The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4. Higher scores indicates more severe freezing of gait. Step count performance may also be used to evaluate fall prediction. The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch
Time frame: 2-3 years
Disease progression may be evaluated by predicting the levodopa response using severity levels of the Bradykinesia Score (BKS) and early morning Bradykinesia. Changes in PKG measurements may be compared to the MDS-UPDRS which evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms.
Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales
Time frame: 2-3 years
PKG system data may be compared to non-motor assessments such as the non-motor questionnaire (NMSQ). The NMSQ includes questions regarding non-motor symptoms such as difficulty swallowing, constipation, difficulty sleeping, cognition, mood. Higher scores indicate more non-motor symptoms.
11 secondary outcomes
Evaluation of PKG scores to assess differences by age category
Time frame: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale
Time frame: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q)
Time frame: 2-3 years
To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS)
Time frame: 2-3 years
To compare PKG scores to subject diaries
Time frame: 2-3 years
To compare PKG scores to non-motor assessments such as the Non-Motor Symptoms Questionnaire (NMSQ)
Time frame: 2-3 years
To compare PKG scores to sleep assessments such as Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS)
Time frame: 2-3 years
To compare PKG scores to the Montreal Cognitive Assessment (MoCA)
Time frame: 2-3 years
To compare PKG scores to quality of life measurements such as EuroQual 5-D (EQ-5D)
Time frame: 2-3 years
To evaluate product usability and satisfaction for PKG Watch, docking station and PKG Portal
Time frame: 2-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Background: PubMed 23939408Griffiths RI, Kotschet K, Arfon S, Xu ZM, Johnson W, Drago J, Evans A, Kempster P, Raghav S, Horne MK. Automated assessment of bradykinesia and dyskinesia in Parkinson's disease. J Parkinsons Dis. 2012;2(1):47-55. doi: 10.3233/JPD-2012-11071.
- Background: PubMed 25928634Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
- Background: PubMed 24674770Kotschet K, Johnson W, McGregor S, Kettlewell J, Kyoong A, O'Driscoll DM, Turton AR, Griffiths RI, Horne MK. Daytime sleep in Parkinson's disease measured by episodes of immobility. Parkinsonism Relat Disord. 2014 Jun;20(6):578-83. doi: 10.1016/j.parkreldis.2014.02.011. Epub 2014 Feb 24.
- Background: PubMed 27589540Braybrook M, O'Connor S, Churchward P, Perera T, Farzanehfar P, Horne M. An Ambulatory Tremor Score for Parkinson's Disease. J Parkinsons Dis. 2016 Oct 19;6(4):723-731. doi: 10.3233/JPD-160898.
- Individual participant dataSharing planned: Undecided. Any clinical study IPD may be made available to other researchers including PKG data; demographics, such as age, gender, ethnicity; medical history, such as comorbid conditions and movement disorder history. Subject data will not include any personally identifiable information.
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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. This study is not recruiting at the moment.
Zoltan Mari, MD principal investigator
Z Neurosciences, LLC.
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 Movement Disorders and Parkinson Disease, run by Global Kinetics Corporation at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 14 Oct 2025. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch (time frame: 2-3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251701, which also lists 4 linked publications.
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 14 Oct 2025.