| CTRI Number |
CTRI/2025/09/094360 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post stroke assessment |
|
Scientific Title of Study
|
Post–stroke kinematic analysis in functional task of the upper extremity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
padmavathi shenoy |
| Designation |
Research scholar |
| Affiliation |
Manipal Institute of Technology |
| Address |
Department of Instrumentation and Control Engineering
Manipal Institute of Technology
Manipal Academy of Higher Education
Manipal, India
Udupi
KARNATAKA
576104
India |
| Phone |
7899093783 |
| Fax |
|
| Email |
padmavathi.mitmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenatchi Sundaram S |
| Designation |
Head of the department |
| Affiliation |
Manipal Institute of Technology |
| Address |
Department of Instrumentation and Control Engineering
Manipal Institute of Technology
Manipal Academy of Higher Education
Manipal, India
Udupi
KARNATAKA
576104
India |
| Phone |
9448547155 |
| Fax |
|
| Email |
meena.sundar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Senthil Kumaran D |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal, India
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Kasturba Hospital Manipal - 576104, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
padmavathi shenoy |
| Address |
Research scholar
instrumentation and control engineering, manipal institute of technology, manipal 576104 |
| Type of Sponsor |
Other [Self sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Senthil Kumaran D |
Physiotherapy OPD |
Department of Physiotherapy at Kasturba Hospital, Manipal
Udupi
KARNATAKA |
09986910303
senthil.kumaran@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospitalinstitutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G46||Vascular syndromes of brain in cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 18 to 80 years
2)Gender male and female
3)Unilateral stroke patient
4)No prior deformities in joints
5)Stroke survivor
6)Healthy person
|
|
| ExclusionCriteria |
| Details |
1)Individual who are unable to perform drinking water task or unable to lift his or her hand
2) Individual with any pre existing impairment affecting the upper extrimity
3)Participants not willing to give consent or uncooperative
4)Individual with bilatral stroke
5)Individual with conditions that are restricting kinematic analysis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Real-time measurement of shoulder, elbow, wrist and finger joint angles (degrees) and range of motion (degrees) during a standardized drinking-water task, recorded at a single cross-sectional visit using a Raspberry Pi–based camera system with automated video-based joint angle estimation. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraclass Correlation Coefficient (ICC, two-way mixed, absolute agreement) between Raspberry Pi system & Kinovea for joint angles & ROM.
Bland–Altman analysis (mean bias & 95% limits of agreement) for joint angles & ROM.
Mean Absolute Error (MAE, degrees) & Root Mean Square Error (RMSE, degrees) between the two systems. |
6 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/12/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is an observational cross sectional study designed to record upper limb movement in stroke patients during a standardized drinking water task. A Raspberry Pi based camera system will be used to measure shoulder elbow wrist and finger joint angles and range of motion in real time. The results from this device will be compared with Kinovea software to assess agreement between the two measurement methods. The study aims to provide objective assessment of upper limb motor function in post stroke individuals and to evaluate the accuracy of the newly developed device. |