| CTRI Number |
CTRI/2025/05/086181 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Brain Activity Pattern in Stroke Patients While Performing Hand Gestures: A Cross-Sectional Analytical Study. |
|
Scientific Title of Study
|
Brain Activation Pattern in Stroke Patients While Performing Gesture Components of A Clinical Prognostic Tool: A Cross-Sectional Analytical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskhan |
| Designation |
Post graduate Student |
| Affiliation |
Kasturba Medical College ,Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College, Centre of Basic Sciences, Bejai, Mangalore, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7760093767 |
| Fax |
|
| Email |
muskannadaf10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abraham M Joshua |
| Designation |
Additional Professor,Department of Physiotherapy,Kasturba Medical College ,Mangalore. |
| Affiliation |
Kasturba Medical College ,Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College, Centre of Basic Sciences, Bejai, Mangalore, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Abraham M Joshua |
| Designation |
Additional Professor,Department of Physiotherapy,Kasturba Medical College ,Mangalore. |
| Affiliation |
Kasturba Medical College ,Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College, Centre of Basic Sciences, Bejai, Mangalore, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College ,Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College ,Mangalore |
| Address |
Kasturba Medical College, Mangalore, 575004 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Muskhan |
Kasturba Medical College , Attavar,Mangalore |
Department of Physiotherapy and Department of Radiology
Dakshina Kannada
KARNATAKA |
07760093767
muskannadaf10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,KSTURBA MEDICAL COLLEGE ,MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 65 years with primary ischemic supratentorial stroke in the middle cerebral artery territory acute or sub-acute phase medically stable after 72 hours
Brunnstrom stage of hand recovery between 3 to 5
Age and gender matched controls
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Region of interest (ROI) accounts for global signal variations
2. BOLD signal changes per ROI represented by the mean beta value during each task
3. Laterality Index (LI):
Quantifies hemispheric dominance in activation.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Region of interest (ROI) accounts for global signal variations
2. BOLD signal changes per ROI represented by the mean beta value during each task
3. Laterality Index (LI):
Quantifies hemispheric dominance in activation.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2025 |
| 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="1"
Months="3"
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
|
The study, Brain Activation Pattern in Stroke Patients While Performing Gesture Components of a Clinical Prognostic Tool: A Cross-Sectional Analytical Study, aims to explore the brain activation pattern in stroke patients while performing gesture components of a clinical prognostic tool.Selected Participants: Subjects diagnosed with stroke along with age and gender-matched controls. In this study, informed consent will be obtained from the participants willing to participate, participant demographic data will be collected, and routine clinical evaluation will be done. Then Cognitive screening will be done using the Montreal Cognitive Assessment Scale, the Wolf Motor Function Tool (WMFT), and the Bedside Upper Limb Functional Evaluation Tool (BUFET) will be used to test upper limb motor function. Participants will be instructed on how to perform the gesture components of the BUFET. A structural MRI will be taken while subjects are positioned, and their heads will be held in place to limit movement. The individual will do the gesture components of BUFET in an fMRI scanner to find out which part of the brain are involved in movement actions |