Development of Parkinson's Glove for Detection and Suppression of Hand Tremor
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|ClinicalTrials.gov Identifier: NCT02370134|
Recruitment Status : Unknown
Verified February 2015 by Roongroj Bhidayasiri, Chulalongkorn University.
Recruitment status was: Not yet recruiting
First Posted : February 24, 2015
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Parkinson's glove Device: sham glove||Phase 1|
- Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||May 2017|
Experimental: Parkinson's glove
Parkinson's glove 14 days use with 4 times follow-up
Device: Parkinson's glove
Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation
Placebo Comparator: sham glove
sham glove (with light and sound)14 days use with 4 times follow-up
Device: sham glove
- Number of participants who demonstrate the tremor suppression after use parkinson's glove [ Time Frame: up to 1 month follow up period ]To determine the tremor suppression after use the parkinson's glove by the tremor rating scale
- Number of Participants who report pain or any adverse events from parkinson's glove [ Time Frame: 14 days periods of using parkinson's glove and in subsequent 1 month follow up period ]To determine the safety of parkinson's glove
- Determine the severity of pain related with parkinson's glove [ Time Frame: 14 days periods of using parkinson's glove ]To determine the severity of pain by visual analog scale
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): NCT02370134
|Contact: Onanong Jitkritsadakul, MD, MScemail@example.com|
|Contact: Roongroj Bhidayasiri, MD, FRCPfirstname.lastname@example.org|
|Chulalongkorn University Hospital||Not yet recruiting|
|Pathumwan, Bangkok, Thailand, 10330|
|Contact: Roongroj Bhidayasiri, MD +662 256 4630 email@example.com|
|Principal Investigator: Roongroj Bhidayasiri, MD|
|Study Director:||Roongroj Bhidayasiri, MD, FRCP||Chulalongkorn University|