| CTRI Number |
CTRI/2025/07/091577 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding recovery determinants in people after moderate and severe brain injury |
|
Scientific Title of Study
|
Factors Influencing Functional Recovery in Individuals with Moderate and Severe Traumatic Brain Injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gandhali Pradeep Hardikar |
| Designation |
Postgraduate student of Physiotherapy |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Physiotherapy Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9987556183 |
| Fax |
|
| Email |
gandhali.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr John Solomon M |
| Designation |
Additional Professor & Associate Dean |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva M Shankaranarayana |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9591976213 |
| Fax |
|
| Email |
apoorva.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department Of Physiotherapy MCHP MAHE Manipal Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Gandhali Prdaeep Hardikar |
| Address |
Department of Physiotherapy MCHP MAHE Manipal Karnataka India 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Gandhali P Hardikar PT |
Kasturba Hospital |
Dhanwantari ward 3rd floor Kasturba Hospital Manipal Udupi Karnataka India 576104
Udupi
KARNATAKA |
9987556183
gandhali.mchpmpl2024@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College And Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S098||Other specified injuries of head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with moderate to severe TBI (GCS 3-12 within first 48 hours)
2. Age between 18-65 years
3. Both sexes
4. Time Since Injury (5–7 Days Post-Injury) |
|
| ExclusionCriteria |
| Details |
1. Individuals with severe systemic conditions or medically unstable
2. Any previously diagnosed neurological or psychiatric conditions (such as epilepsy, major depressive disorder, or schizophrenia)
3. Any recent Spinal or Lower limb fracture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glasgow Outcome Scale-Extended (GOS-E)
Modified Functional Ambulation Category (mFAC) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glasgow Coma Scale
Modified Kuppuswamy Socioeconomic Scale
JFKs Coma Recovery Scale-Revised
Modified Ashworth Scale
Rancho Los Amigos Scale
Disability Rating Scale |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
04/08/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This prospective longitudinal study titled Factors Influencing Functional Recovery in Individuals with Moderate and Severe Traumatic Brain Injury seeks to understand how demographic variables, sensorimotor, cognitive behavioural factors, and other functional determinants impact recovery.
Inclusion criteria will be participants between 18 and 85 years old of either sex with a Glasgow Coma Scale score of 3 to 12 and assessed within 5 to 7 days post injury.
Exclusion criteria include severe systemic conditions, pre-existing neurological or psychiatric conditions, and recent spinal or lower limb fractures.
This study aims to identify factors that can improve recovery strategies by providing useful insights that might help in better treatment plans and enhancing the quality of life for TBI patients. |