| CTRI Number |
CTRI/2025/08/093483 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
A study in people who have tremors using computer-based video analysis to detect and differentiate Parkinson’s, Essential, and Cerebellar tremors. |
|
Scientific Title of Study
|
Analysis of Pose-Driven Computer Vision Algorithm for Tremor Differentiation |
| 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 K A Sunitha |
| Designation |
Assoc Prof HoD |
| Affiliation |
SRM University AP |
| Address |
SRM UNIVERSITY
NEERUKONDA
MANGALAGIRI
GUNTUR DT
Guntur ANDHRA PRADESH 522240 India |
| Phone |
9600086770 |
| Fax |
|
| Email |
sunitha.ka@srmap.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K A Sunitha |
| Designation |
Assoc Prof HoD |
| Affiliation |
SRM University AP |
| Address |
SRM UNIVERSITY
NEERUKONDA
MANGALAGIRI
GUNTUR DT
ANDHRA PRADESH 522240 India |
| Phone |
9600086770 |
| Fax |
|
| Email |
sunitha.ka@srmap.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr K A Sunitha |
| Designation |
Assoc Prof HoD |
| Affiliation |
SRM University AP |
| Address |
SRM UNIVERSITY
NEERUKONDA
MANGALAGIRI
GUNTUR DT
ANDHRA PRADESH 522240 India |
| Phone |
9600086770 |
| Fax |
|
| Email |
sunitha.ka@srmap.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM UNIVERSITY |
| Address |
SRM UNIVERSITY AP
NEERU KONDA
MANGALAGIRI
GUNTUR DT |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS MANGALAGIRI |
MANGALAGIRI
GUNTUR DT |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alex Rebello |
AIIMS |
DEPARTMENT OF NEUROLOGY
OPB BLOCK
ROOM NO.211
MANGALAGIRI
GUNTUR DT Guntur ANDHRA PRADESH |
8110087168
dralexrebello@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
NIL |
| Comparator Agent |
Not Applicable |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged above 18 years with a confirmed diagnosis of Rest Tremor, Essential Tremor, or Cerebellar Tremor.
2.Patients willing to provide written informed consent.
3.Ability to maintain predefined poses (e.g., rest, extended arm, intentional movement) during data collection. |
|
| ExclusionCriteria |
| Details |
1.Patients with cognitive impairments preventing compliance.
2.Patients with other movement disorders not related to tremor.
3.Patients unwilling or unable to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the accurate identification of tremor types using the developed computer vision system, validated by healthcare experts. |
Outcome will be assessed at Baseline (Day 0), Week 4, and Week 8, using the computer vision system with concurrent expert validation at each visit.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study aims to differentiate between rest tremor, essential tremor, & cerebellar tremor, each associated with distinct neurological pathways & clinical characteristics |
Baseline (Day 0), Week 2, Week 4, & Week 8 |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| Date of Study Completion (India) |
17/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This pilot study aims to evaluate the efficacy of a computer vision-based
system developed to differentiate between rest tremor, essential tremor, and
cerebellar tremor. The study will involve a total of 75 subjects, with 25
participants in each tremor category, selected from various age groups above 18
years. Each subject will be independently evaluated using the developed
computer vision system. The system utilizes video recordings of the patients’
hand and limb movements, focusing on capturing tremor activity during
standardized postures. These include the rest pose (with hands placed on the
knees while seated), the stretched hand pose (arms extended parallel to the
ground), and intentional movement tasks (such as finger-to-nose or
object-reaching movements). Each participant is required to sit for a maximum
of 10 minutes to complete the evaluation individually. The recorded videos are
processed using the developed computer vision algorithms to extract key motion
features such as tremor frequency and trajectory patterns. These features are
then analyzed to differentiate between Parkinsonian tremor, essential tremor,
and cerebellar tremor. |