The Measurement of Nocturnal Hypokinesia in Parkinson's Disease (PD) Patient Compared With Spouse by Wearable Sensors

Parkinson Disease Clinical Trial

— PD  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02352727
• Other study ID #: 153/57
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 23, 2015
• Last updated: January 28, 2015
• Start date: May 2014

Study information

• Verified date: January 2015
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 28
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Thailand	Faculty of Medicine	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

Bhidayasiri 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. — View Citation

Chaudhuri 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. Review. — View Citation

Godfrey 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. Review. — View Citation

Maetzler 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. Review. — View Citation

Salarian 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. — View Citation

Stack EL, Ashburn AM. Impaired bed mobility and disordered sleep in Parkinson's disease. Mov Disord. 2006 Sep;21(9):1340-2. — View Citation

Steiger MJ, Thompson PD, Marsden CD. Disordered axial movement in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1996 Dec;61(6):645-8. — View Citation

Verbaan 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. — View Citation

Weller 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. — View Citation

Weller 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. — View Citation

Yang 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of nocturia of Parkinson's disease patient		one year	No
Primary	the number of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer		one year	No
Primary	the velocity of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer		one year	No
Primary	the acceleration of axial movement of Parkinson's disease patients compare to their spouses by accelerometer		one year	No
Secondary	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.	one year	No
Secondary	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.	one year	No
Secondary	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.	one year	No