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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
Study Population
Study methods as follows:
Data collection
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's glove | Experimental | Parkinson's glove 14 days use with 4 times follow-up |
|
| sham glove | Placebo Comparator | sham glove (with light and sound)14 days use with 4 times follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parkinson's glove | Device | Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who demonstrate the tremor suppression after use parkinson's glove | To determine the tremor suppression after use the parkinson's glove by the tremor rating scale | up to 1 month follow up period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who report pain or any adverse events from parkinson's glove | To determine the safety of parkinson's glove | 14 days periods of using parkinson's glove and in subsequent 1 month follow up period |
| Determine the severity of pain related with parkinson's glove |
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Inclusion Criteria:
• Adults ≥ 18 years old.
Exclusion Criteria:
Patients with a history of cardiac arrhythmia, renal failure, hepatic failure, and pregnancy as well as those who had history of seizure or had the risk for tended to become seizure such as those who had focal brain lesions, encephalitis, and stroke patients.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Onanong Jitkritsadakul, MD, MSc | Contact | 0863570212 | onanong.jit@gmail.com | |
| Roongroj Bhidayasiri, MD, FRCP | Contact | 022564630 | rbh1@ucla.com |
| Name | Affiliation | Role |
|---|---|---|
| Roongroj Bhidayasiri, MD, FRCP | Chulalongkorn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University Hospital | Pathumwan | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| sham glove | Device |
|
To determine the severity of pain by visual analog scale |
| 14 days periods of using parkinson's glove |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |