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CTRI Number  CTRI/2025/12/098825 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Wearable Device to Measure Tremors in Parkinsonism patients 
Scientific Title of Study   Wearable device to assess tremors in Parkinsonism Patients 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR GOWTHAM GANAPATHY  
Designation  Post Graduate, General Medicine 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9677769775  
Fax    
Email  Gotham431@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MAHENDRAN K 
Designation  Post Graduate, General Medicine 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9444148005  
Fax    
Email  mahension@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GOWTHAM GANAPATHY  
Designation  Post Graduate, General Medicine 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai


TAMIL NADU
602105
India 
Phone  9677769775  
Fax    
Email  Gotham431@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu 
 
Primary Sponsor  
Name  Saveetha Medical College and Hospital 
Address  Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR GOWTHAM GANAPATHY   SAVEETHA MEDICAL COLLEGE AND HOSPITAL  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU 
9677769775

Gotham431@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Clinically diagnosed Parkinsonism idiopathic Parkinsons disease or other Parkinsonian syndromes
2 Presence of rest postural or action tremor on clinical examination
3 Able to undergo wearable device recording and UPDRS assessment during the study visit
4 Able to provide informed consent 
 
ExclusionCriteria 
Details  1 Presence of other movement disorders that may interfere with tremor assessment such as severe chorea dystonia with prominent irregular movements essential tremor without Parkinsonism
2 Patients with implanted electronic devices that may interfere with sensor function such as deep brain stimulator not in stable mode
3 Severe cognitive impairment or inability to follow instructions
4 Acute medical illness preventing participation
5 Dermatological or musculoskeletal conditions that preclude safe placement of wearable sensors
6 Inability or unwillingness to participate in followup for secondary outcomes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Agreement between wearable sensor tremor metric and clinician-rated MDS-UPDRS tremor score (rest/postural/kinetic).  Day 1, day 30,day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Exploratory — effect on medication titration as informed by monitoring (if applicable)  Day 1, day 30, day 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Assessment of Tremors in Parkinsonism Patients Using a Wearable Sensor Device is a prospective observational single arm cross sectional validation study with longitudinal follow up. The study aims to validate wearable sensor tremor measurements against clinician rated MDS UPDRS tremor scores and to evaluate the reliability, responsiveness, and feasibility of device derived metrics over time. Primary assessment will be agreement between device metrics and clinical scores at Day 1, Day 30, and Day 90. Secondary assessments include responsiveness to medication changes, test retest reliability, feasibility of device use, diagnostic accuracy, and stability of tremor burden. The study includes adults aged 18 to 80 years with clinically diagnosed Parkinsonism and detectable tremor, and excludes those with interfering movement disorders, implanted devices, severe cognitive impairment, unstable illness, or inability to attend follow up visits. A total of 80 participants will be enrolled with an expected 60 completing the Day 90 visit. Total duration is approximately nine to eleven months.


 
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