Parkinson DiseaseWestPORTSNCT03130595
West Sweden Parkinson Objective Measurement Registry Study
An observational study of Parkinson Disease and Parkinsonism, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease, Parkinsonism, Parkinsonian Disorders
- How many people
- 320 participants
- Where
- 1 siteSweden
- Study dates
- 26 Apr 2017to Dec 2030
- How long will I take part?
- 15 Years
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25% of the population described by the inclusion criteria
Who may be able to join
- Medical record with a G209 (Parkinson's disease) diagnosis
- A visit to one of the participating outpatient clinics in West Sweden within the last 6 months
- Informed consent
Who cannot join
- Diagnosis revised before visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: West Sweden Parkinson Objective Measurement Registry Study - an Observational Cohort Study of the Prevalence and Development of Motor Symptoms Assessed With Automated Accelerometry in People With Parkinson's Disease in West Sweden
WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018.
Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will be made with regular intervals of up to 2 years as long as subjects are alive and willing.
Read the detailed description
The following data will be collected at baseline:
Date of birth Handedness Family history of Parkinson's disease Time of first motor symptom onset Laterality of symptom onset Time of diagnosis Time of first pharmacological intervention (if applicable) First antiparkinsonian drug
The following data will be collected at every visit/update Current living conditions Current non motor complications Current medications Hoehn and Yahr staging Clinical Impression of Severity Index in Parkinson's disease (CISI-PD)
Patient self assessments: PDQ8, NMS-Questionnaire, EQ5D-5L, Patient Reported Outcome in Parkinson's Disease (PRO-PD)
Parkinson Kinetigraph (PKG) accelerometry based recording of spontaneous movement patterns over a 6x24h period. The following indices will be extracted: median bradykinesia score (BKS), median dyskinesia score (DKS), Fluctuation Dyskinesia Score (FDS), Percent daytime with Immobility (PTI%), Percent daytime with tremor (PTT%).
The primary analysis will be descriptive and include demographic composition of the population, clinical characteristics and objective measurement data. In addition to indices a standardized qualitative assessment of PKG recordings will be made to identify motor fluctuations. Correlations between clinical ratings, patient reported outcomes, disease duration, age, medication and objective measurement indices will be studied
In the prospective phase of the study the development of objective movement recordings will be studied along with the development of clinical ratings and patient reported outcomes.
- Conditions
- Parkinson Disease, Parkinsonism, Parkinsonian Disorders
- Keywords
- accelerometry, Parkinson Kinetigraph
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
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 |
|---|---|---|
| PD outpatients in West Sweden | Cross-sectional random sample of patients with PD that have visited outpatient clinics in West Sweden in the last 6+6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective measurement of spontaneous movement patterns
Parkinson Kinetigraph
Measured: 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start26 Apr 2017
- Primary completionMay 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Filip Bergquist, Sahlgrenska University Hospital
- Investigators
- Filip Bergquist, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130595
- Sponsor's protocol ID
- WestPORTS
- Other IDs
- PARKreg
- Acronym
- WestPORTS
- Status last verified
- Nov 2024
- First submitted
- 22 Apr 2017
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical registry data will be immediately available as part of the national Parkinson Registry. Study specific data from objective measurements will be made available within the registry one year after final subject has been recruited. Access to data requires ethical permission and permission from the registry scientific committee SWEPAR.
Publications
von Below D, Wallerstedt SM, Bergquist F. Wearable sensor measurements in relation to clinical characteristics and mortality in patients with Parkinson's disease. Neurol Res Pract. 2026 Mar 11;8(1):14. doi: 10.1186/s42466-026-00474-8.
PubMed 41814450
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- West Sweden Parkinson Objective Measurement Registry Study - an Observational Cohort Study of the Prevalence and Development of Motor Symptoms Assessed With Automated Accelerometry in People With Parkinson's Disease in West Sweden
- ClinicalTrials.gov ID
- NCT03130595
- Acronym / sponsor ID
- WestPORTS / WestPORTS
- Conditions
- Parkinson Disease, Parkinsonism, Parkinsonian Disorders
- Keywords
- accelerometry, Parkinson Kinetigraph
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Apr 2017 (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.
WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018.
Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will be made with regular intervals of up to 2 years as long as subjects are alive and willing.
Detailed description
The following data will be collected at baseline:
Date of birth Handedness Family history of Parkinson's disease Time of first motor symptom onset Laterality of symptom onset Time of diagnosis Time of first pharmacological intervention (if applicable) First antiparkinsonian drug
The following data will be collected at every visit/update Current living conditions Current non motor complications Current medications Hoehn and Yahr staging Clinical Impression of Severity Index in Parkinson's disease (CISI-PD)
Patient self assessments: PDQ8, NMS-Questionnaire, EQ5D-5L, Patient Reported Outcome in Parkinson's Disease (PRO-PD)
Parkinson Kinetigraph (PKG) accelerometry based recording of spontaneous movement patterns over a 6x24h period. The following indices will be extracted: median bradykinesia score (BKS), median dyskinesia score (DKS), Fluctuation Dyskinesia Score (FDS), Percent daytime with Immobility (PTI%), Percent daytime with tremor (PTT%).
The primary analysis will be descriptive and include demographic composition of the population, clinical characteristics and objective measurement data. In addition to indices a standardized qualitative assessment of PKG recordings will be made to identify motor fluctuations. Correlations between clinical ratings, patient reported outcomes, disease duration, age, medication and objective measurement indices will be studied
In the prospective phase of the study the development of objective movement recordings will be studied along with the development of clinical ratings and patient reported outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD outpatients in West Sweden | – | –Cross-sectional random sample of patients with PD that have visited outpatient clinics in West Sweden in the last 6+6 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25% of the population described by the inclusion criteria
Key inclusion criteria (3 listed)
- Medical record with a G209 (Parkinson's disease) diagnosis
- A visit to one of the participating outpatient clinics in West Sweden within the last 6 months
- Informed consent
Key exclusion criteria (1 listed)
- Diagnosis revised before visit.
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
Objective measurement of spontaneous movement patterns
Time frame: 144 hours
Parkinson Kinetigraph
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 27 Nov 2024.
- Derived from this study: PubMed 41814450von Below D, Wallerstedt SM, Bergquist F. Wearable sensor measurements in relation to clinical characteristics and mortality in patients with Parkinson's disease. Neurol Res Pract. 2026 Mar 11;8(1):14. doi: 10.1186/s42466-026-00474-8.
- Individual participant dataSharing planned: Yes. Clinical registry data will be immediately available as part of the national Parkinson Registry. Study specific data from objective measurements will be made available within the registry one year after final subject has been recruited. Access to data requires ethical permission and permission from the registry scientific committee SWEPAR.
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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.
Filip Bergquist, MD, PhD principal investigator
Göteborg 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 and Parkinsonism, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. 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 Sweden. 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?
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?
Objective measurement of spontaneous movement patterns (time frame: 144 hours). 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 NCT03130595, which also lists 1 linked publication.
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 27 Nov 2024.