Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-06 @ 7:05 PM
Study NCT ID:
NCT02370134
Status:
UNKNOWN
Last Update Posted:
2015-02-24
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Parkinson's Glove for Detection and Suppression of Hand Tremor
Sponsor:
Chulalongkorn University
Organization:
Study Overview
Official Title:
Development of Parkinson's Glove for Detection and Suppression of Hand Tremor at Rest Among the Tremor-predominant Parkinson's Disease Patients With Medically Intractable Tremor
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is aimed to study the feasibility and safety of parkinson's glove that combined 2 module of tremor detection and tremor suppression with electrical muscle stimulation for using as device for rest tremor suppression in parkinson's disease patients
Detailed Description:
Study Population
1. Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients
2. Population sample: Patients who are getting their treatment at the Chulalongkorn Comprehensive Movement Disorder Clinic at King Chulalongkorn Memorial Hospital.
Study methods as follows:
* All PD subjects will be provided the information on this research study and informed consent will be sought for every subjects.
* All PD subjects will be interviewed by a movememt disorders specialist or a trained interviewer for their demographic and clinical data.
* All PD patients will be examined for the severity of Parkinson's disease by a movement disorders specialist according the Unified Parkinson's disease Rating Scale (UPDRS), Hoehn and Yahr score, and tremor rating scale during the 'on period' in order to determine the additional effect of parkinson's glove and sham glove for suppression of tremor
* All PD patients will be randomly allocated into 2 groups (25 Parkinson's glove and 25 sham glove) with block randomization method.
* All patients will get Parkinson's glove for home-based usage for 14 days, the appointment for follow -up will be done for 4 times, with once daily phone call from investigators in order to check for improvement symptoms and all adverse events such as pain will be recorded and determined it severity by the visual analog scale.
Data collection
* Demographic and clinical data: age, gender, clinical diagnosis, tremor rating scale, pain score by visual analog scale , Parkinson's disease's severity score for each subject according to establishing standard rating scale.
* Tremor parameters form Parkinson's glove will be collected in SD card as 5 parameters: Peak magnitude, RMS, Angle, Frequency, Q. Number of stimulation times will be recorded.
Data analysis The statistical analysis in this study is based from SPSS program version 17. Categorical data will be analyzed for frequency and percentage. Continuous data will be analyzed by mean and standard deviation (SD). Non-parametric study would be preferred if the small sample size or in case of distribution of data do not present as normal distribution (determined by Kolmogorov-Smirnov test). The repeated ANOVA will be used for determined the efficacy of parkinson's glove in the difference times in follow up periods.
1. Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients
2. Population sample: Patients who are getting their treatment at the Chulalongkorn Comprehensive Movement Disorder Clinic at King Chulalongkorn Memorial Hospital.
Study methods as follows:
* All PD subjects will be provided the information on this research study and informed consent will be sought for every subjects.
* All PD subjects will be interviewed by a movememt disorders specialist or a trained interviewer for their demographic and clinical data.
* All PD patients will be examined for the severity of Parkinson's disease by a movement disorders specialist according the Unified Parkinson's disease Rating Scale (UPDRS), Hoehn and Yahr score, and tremor rating scale during the 'on period' in order to determine the additional effect of parkinson's glove and sham glove for suppression of tremor
* All PD patients will be randomly allocated into 2 groups (25 Parkinson's glove and 25 sham glove) with block randomization method.
* All patients will get Parkinson's glove for home-based usage for 14 days, the appointment for follow -up will be done for 4 times, with once daily phone call from investigators in order to check for improvement symptoms and all adverse events such as pain will be recorded and determined it severity by the visual analog scale.
Data collection
* Demographic and clinical data: age, gender, clinical diagnosis, tremor rating scale, pain score by visual analog scale , Parkinson's disease's severity score for each subject according to establishing standard rating scale.
* Tremor parameters form Parkinson's glove will be collected in SD card as 5 parameters: Peak magnitude, RMS, Angle, Frequency, Q. Number of stimulation times will be recorded.
Data analysis The statistical analysis in this study is based from SPSS program version 17. Categorical data will be analyzed for frequency and percentage. Continuous data will be analyzed by mean and standard deviation (SD). Non-parametric study would be preferred if the small sample size or in case of distribution of data do not present as normal distribution (determined by Kolmogorov-Smirnov test). The repeated ANOVA will be used for determined the efficacy of parkinson's glove in the difference times in follow up periods.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: