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

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ClinicalTrials.gov Identifier: NCT02352727
Recruitment Status : Unknown
Verified January 2015 by Jirada Sringean, Chulalongkorn University.
Recruitment status was:  Enrolling by invitation
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Jirada Sringean, Chulalongkorn University

Brief 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.

Condition or disease
Parkinson Disease

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.

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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : May 2014
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. the number of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer [ Time Frame: one year ]
  2. the velocity of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer [ Time Frame: one year ]
  3. the acceleration of axial movement of Parkinson's disease patients compare to their spouses by accelerometer [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The correlations between nocturnal hypokinesia parameter (number of axial movement) and severity of Parkinson's disease. [ Time Frame: one year ]
    The correlation between number of axial movement and UPDRS.

  2. The correlations between nocturnal hypokinesia parameter (velocity of axial movement) and severity of Parkinson's disease. [ Time Frame: one year ]
    The correlation between velocity of axial movement and UPDRS.

  3. The correlations between nocturnal hypokinesia parameter (degree of axial movement) and severity of Parkinson's disease. [ Time Frame: one year ]
    The correlation between degree of axial movement and UPDRS.


Other Outcome Measures:
  1. The number of nocturia of Parkinson's disease patient [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
we study the Parkinson's disease patients and their spouses who received the treatment at King Chulalongkorn Memorial Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352727


Locations
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Thailand
Faculty of Medicine
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Publications of Results:
Other Publications:

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Responsible Party: Jirada Sringean, Dr, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02352727    
Other Study ID Numbers: 153/57
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Jirada Sringean, Chulalongkorn University:
Nocturnal hypokinesia
Accelerometers
Additional relevant MeSH terms:
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Parkinson Disease
Hypokinesia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms