Parkinson DiseasePDNCT02352727
The Measurement of Nocturnal Hypokinesia in Parkinson's Disease (PD) Patient Compared With Spouse by Wearable Sensors
An observational study of Parkinson Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients compares with their spouses by using multisite accelerometers for 1 night at their home. To determine whether the nocturnal movement of Parkinson's disease patients less than normal elderly people or not. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Jan 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: we study the Parkinson's disease patients and their spouses who received the treatment at King Chulalongkorn Memorial Hospital.
Who may be able to join
- Parkinson's disease patients who met the criteria diagnosis of United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) with their spouses which age difference less than 10 years.
Who cannot join
- 1) patients and/or spouses who were bed ridden,
- 2) a history of other neurological diseases or other muscle and joint diseases,
- 3) no history of hypnotic drug use
Trial locations and contacts
1 site in 1 country.
About this study
To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients compares with their spouses by using multisite accelerometers for 1 night at their home. To determine whether the nocturnal movement of Parkinson's disease patients less than normal elderly people or not.
Read the detailed description
To quantify the severity of nocturnal akinesia, the nocturnal akinesia dystonia and cramp score (NADCS) and Unified Parkinson's Disease Rating Scale (UPDRS) were recorded in the patient group and also details of demographic data, history and physical examinations were included. The patients and spouses wore the 3-axis (x,y,z) accelerometers at bilateral wrists, bilateral ankles, and trunk for 1 night at their home. The 5-minute periods after going to bed and before waking up in the morning were excluded from the analysis. The definition of movement of the trunk is a change of 15 degrees from the previous position and sustained for 5 minutes in any axis. The movement of limbs is defined as a change of 15 degrees from the previous position and sustained for 2 minutes.
- Conditions
- Parkinson Disease
- Keywords
- Nocturnal hypokinesia, Accelerometers
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer
Measured: one year
the velocity of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer
Measured: one year
the acceleration of axial movement of Parkinson's disease patients compare to their spouses by accelerometer
Measured: one year
Secondary outcomes (3)
The correlations between nocturnal hypokinesia parameter (number of axial movement) and severity of Parkinson's disease.
The correlation between number of axial movement and UPDRS.
Measured: one year
The correlations between nocturnal hypokinesia parameter (velocity of axial movement) and severity of Parkinson's disease.
The correlation between velocity of axial movement and UPDRS.
Measured: one year
The correlations between nocturnal hypokinesia parameter (degree of axial movement) and severity of Parkinson's disease.
The correlation between degree of axial movement and UPDRS.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jirada Sringean, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352727
- Sponsor's protocol ID
- 153/57
- Acronym
- PD
- Status last verified
- Jan 2015
- First submitted
- 23 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
Publications
Stack EL, Ashburn AM. Impaired bed mobility and disordered sleep in Parkinson's disease. Mov Disord. 2006 Sep;21(9):1340-2. doi: 10.1002/mds.20944.
PubMed 16773640Chaudhuri KR, Schapira AH. Non-motor symptoms of Parkinson's disease: dopaminergic pathophysiology and treatment. Lancet Neurol. 2009 May;8(5):464-74. doi: 10.1016/S1474-4422(09)70068-7.
PubMed 19375664Verbaan D, van Rooden SM, Visser M, Marinus J, van Hilten JJ. Nighttime sleep problems and daytime sleepiness in Parkinson's disease. Mov Disord. 2008 Jan;23(1):35-41. doi: 10.1002/mds.21727.
PubMed 17960797Steiger MJ, Thompson PD, Marsden CD. Disordered axial movement in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1996 Dec;61(6):645-8. doi: 10.1136/jnnp.61.6.645.
PubMed 8971118Bhidayasiri R, Mekawichai P, Jitkritsadakul O, Panyakaew P, Kaewwilai L, Boonrod N, Petchrutchatachart S, Jagota P, Boonpeng K, Singmaneesakulchai S, Setthawatcharawanich S. Nocturnal journey of body and mind in Parkinson's disease: the manifestations, risk factors and their relationship to daytime symptoms. Evidence from the NIGHT-PD study. J Neural Transm (Vienna). 2014 Aug;121 Suppl 1:S59-68. doi: 10.1007/s00702-014-1199-x. Epub 2014 Mar 31.
PubMed 24682359Salarian A, Russmann H, Vingerhoets FJ, Burkhard PR, Aminian K. Ambulatory monitoring of physical activities in patients with Parkinson's disease. IEEE Trans Biomed Eng. 2007 Dec;54(12):2296-9. doi: 10.1109/tbme.2007.896591.
PubMed 18075046Yang CC, Hsu YL. A review of accelerometry-based wearable motion detectors for physical activity monitoring. Sensors (Basel). 2010;10(8):7772-88. doi: 10.3390/s100807772. Epub 2010 Aug 20.
PubMed 22163626Maetzler W, Domingos J, Srulijes K, Ferreira JJ, Bloem BR. Quantitative wearable sensors for objective assessment of Parkinson's disease. Mov Disord. 2013 Oct;28(12):1628-37. doi: 10.1002/mds.25628. Epub 2013 Sep 12.
PubMed 24030855Weller C, Nicholson PW, Dobbs SM, Bowes SG, Purkiss A, Dobbs RJ. Reduced axial rotation in the spouses of sufferers from clinical idiopathic parkinsonism. Age Ageing. 1992 May;21(3):189-94. doi: 10.1093/ageing/21.3.189.
PubMed 1615781Weller C, Bowes SG, Kirk CA, Nicholson PW, Dobbs RJ, Dobbs SM. Measurement of axial rotation: its relevance to screening for night-time hypokinesia in old age and parkinsonism. Age Ageing. 1991 Jan;20(1):3-7. doi: 10.1093/ageing/20.1.3.
PubMed 2028848Godfrey A, Conway R, Meagher D, OLaighin G. Direct measurement of human movement by accelerometry. Med Eng Phys. 2008 Dec;30(10):1364-86. doi: 10.1016/j.medengphy.2008.09.005. Epub 2008 Nov 8.
PubMed 18996729
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Nocturnal Hypokinesia in Parkinson's Disease (PD) Patient Compared With Spouse by Wearable Sensors
- ClinicalTrials.gov ID
- NCT02352727
- Acronym / sponsor ID
- PD / 153/57
- Conditions
- Parkinson Disease
- Keywords
- Nocturnal hypokinesia, Accelerometers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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.
To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients compares with their spouses by using multisite accelerometers for 1 night at their home. To determine whether the nocturnal movement of Parkinson's disease patients less than normal elderly people or not.
Detailed description
To quantify the severity of nocturnal akinesia, the nocturnal akinesia dystonia and cramp score (NADCS) and Unified Parkinson's Disease Rating Scale (UPDRS) were recorded in the patient group and also details of demographic data, history and physical examinations were included. The patients and spouses wore the 3-axis (x,y,z) accelerometers at bilateral wrists, bilateral ankles, and trunk for 1 night at their home. The 5-minute periods after going to bed and before waking up in the morning were excluded from the analysis. The definition of movement of the trunk is a change of 15 degrees from the previous position and sustained for 5 minutes in any axis. The movement of limbs is defined as a change of 15 degrees from the previous position and sustained for 2 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- we study the Parkinson's disease patients and their spouses who received the treatment at King Chulalongkorn Memorial Hospital.
Key inclusion criteria (1 listed)
- Parkinson's disease patients who met the criteria diagnosis of United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) with their spouses which age difference less than 10 years.
Key exclusion criteria (3 listed)
- 1) patients and/or spouses who were bed ridden,
- 2) a history of other neurological diseases or other muscle and joint diseases,
- 3) no history of hypnotic drug use
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
the number of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer
Time frame: one year
the velocity of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer
Time frame: one year
the acceleration of axial movement of Parkinson's disease patients compare to their spouses by accelerometer
Time frame: one year
3 secondary outcomes
The correlations between nocturnal hypokinesia parameter (number of axial movement) and severity of Parkinson's disease.
Time frame: one year
The correlations between nocturnal hypokinesia parameter (velocity of axial movement) and severity of Parkinson's disease.
Time frame: one year
The correlations between nocturnal hypokinesia parameter (degree of axial movement) and severity of Parkinson's disease.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Background: PubMed 16773640Stack EL, Ashburn AM. Impaired bed mobility and disordered sleep in Parkinson's disease. Mov Disord. 2006 Sep;21(9):1340-2. doi: 10.1002/mds.20944.
- Background: PubMed 19375664Chaudhuri KR, Schapira AH. Non-motor symptoms of Parkinson's disease: dopaminergic pathophysiology and treatment. Lancet Neurol. 2009 May;8(5):464-74. doi: 10.1016/S1474-4422(09)70068-7.
- Background: PubMed 17960797Verbaan D, van Rooden SM, Visser M, Marinus J, van Hilten JJ. Nighttime sleep problems and daytime sleepiness in Parkinson's disease. Mov Disord. 2008 Jan;23(1):35-41. doi: 10.1002/mds.21727.
- Background: PubMed 8971118Steiger MJ, Thompson PD, Marsden CD. Disordered axial movement in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1996 Dec;61(6):645-8. doi: 10.1136/jnnp.61.6.645.
- Background: PubMed 24682359Bhidayasiri R, Mekawichai P, Jitkritsadakul O, Panyakaew P, Kaewwilai L, Boonrod N, Petchrutchatachart S, Jagota P, Boonpeng K, Singmaneesakulchai S, Setthawatcharawanich S. Nocturnal journey of body and mind in Parkinson's disease: the manifestations, risk factors and their relationship to daytime symptoms. Evidence from the NIGHT-PD study. J Neural Transm (Vienna). 2014 Aug;121 Suppl 1:S59-68. doi: 10.1007/s00702-014-1199-x. Epub 2014 Mar 31.
- Background: PubMed 18075046Salarian A, Russmann H, Vingerhoets FJ, Burkhard PR, Aminian K. Ambulatory monitoring of physical activities in patients with Parkinson's disease. IEEE Trans Biomed Eng. 2007 Dec;54(12):2296-9. doi: 10.1109/tbme.2007.896591.
- Background: PubMed 22163626Yang CC, Hsu YL. A review of accelerometry-based wearable motion detectors for physical activity monitoring. Sensors (Basel). 2010;10(8):7772-88. doi: 10.3390/s100807772. Epub 2010 Aug 20.
- Background: PubMed 24030855Maetzler W, Domingos J, Srulijes K, Ferreira JJ, Bloem BR. Quantitative wearable sensors for objective assessment of Parkinson's disease. Mov Disord. 2013 Oct;28(12):1628-37. doi: 10.1002/mds.25628. Epub 2013 Sep 12.
- Results publication: PubMed 1615781Weller C, Nicholson PW, Dobbs SM, Bowes SG, Purkiss A, Dobbs RJ. Reduced axial rotation in the spouses of sufferers from clinical idiopathic parkinsonism. Age Ageing. 1992 May;21(3):189-94. doi: 10.1093/ageing/21.3.189.
- Results publication: PubMed 2028848Weller C, Bowes SG, Kirk CA, Nicholson PW, Dobbs RJ, Dobbs SM. Measurement of axial rotation: its relevance to screening for night-time hypokinesia in old age and parkinsonism. Age Ageing. 1991 Jan;20(1):3-7. doi: 10.1093/ageing/20.1.3.
- Results publication: PubMed 18996729Godfrey A, Conway R, Meagher D, OLaighin G. Direct measurement of human movement by accelerometry. Med Eng Phys. 2008 Dec;30(10):1364-86. doi: 10.1016/j.medengphy.2008.09.005. Epub 2008 Nov 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Chulalongkorn University at 1 site in Thailand.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2015. 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 Thailand. 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?
Results are not available in the source record.
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?
the number of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer (time frame: one year). The study lists 3 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 NCT02352727, which also lists 11 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 2 Feb 2015.