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

• Conditions: Parkinson Disease

• Registration Number: NCT02352727
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-05
• Status Verified: 2015-01
• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-28
• Last Update Submitted: 2015-01-28
• Study First Posted: 2015-02-02
• Last Update Posted: 2015-02-02
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the velocity of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer	one year
the acceleration of axial movement of Parkinson's disease patients compare to their spouses by accelerometer	one year
the number of axial movement of Parkinson's disease patients compare to their spouses defined by accelerometer	one year

Secondary Outcome Measures

Name	Time	Method
The correlations between nocturnal hypokinesia parameter (number of axial movement) and severity of Parkinson's disease.	one year	The correlation between number of axial movement and UPDRS.
The correlations between nocturnal hypokinesia parameter (degree of axial movement) and severity of Parkinson's disease.	one year	The correlation between degree of axial movement and UPDRS.
The correlations between nocturnal hypokinesia parameter (velocity of axial movement) and severity of Parkinson's disease.	one year	The correlation between velocity of axial movement and UPDRS.

Trial Locations

Locations (1)

Faculty of Medicine; 🇹🇭 Bangkok, Thailand