| CTRI Number |
CTRI/2018/03/012581 [Registered on: 15/03/2018] Trial Registered Prospectively |
| Last Modified On: |
14/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Benefits of early rehabilitation on bed mobility and walking following traumatic brain injury |
|
Scientific Title of Study
|
Role of early mobilization on functional mobility following traumatic brain injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Ilapandu Lakshmana Rao |
| Designation |
Masters of Physiotherapy(MPT) Student |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Deparment of Physiotherapy, School of Allied Health Sciences (SOAHS), Manipal Academy of Higher Education, Manipal Hospital, Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9542966184 |
| Fax |
9542966184 |
| Email |
lakshmanphsio1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik Babu S |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Deparment of Physiotherapy, School of Allied Health Sciences (SOAHS), Manipal Academy of Higher Education, Manipal Hospital, Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Divya Mohan |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences (SOAHS), Manipal Academy of Higher Education, HAL Airport Road, Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9886794027 |
| Fax |
|
| Email |
dimspt2002@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, SOAHS, Manipal Academy Of Higher Education, Manipal Hospital, 98, Basement floor, HAL Airport Road, Bangalore - 560017 |
|
|
Primary Sponsor
|
| Name |
SOAHS Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Hospital, HAL Airport Road, Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ilapandu Lakshmana Rao |
Department of Physiotherapy, Manipal Hospital |
School of Allied Health Sciences, Manipal Hospital, HAL Airport Road, BAngalore
Bangalore
KARNATAKA |
9542966184
lakshmanphsio1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Traumatic Head Injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early mobilization |
Structured early mobilization involving coma stimulation, tilt standing, chest care, bed mobility, active movements of extremities based on traumatic brain injury algorithm |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Stable hemodynamics
2) Rankin scale > 2
3) Intra cranial pressure (ICP) < 20 mm Hg
4) Cerebral Perfusion Pressure (CPP) > 60-100 mm Hg
5) Glasgow Coma Scale (GCS) < 8
6) Central Venous Pressure (CVP) 8-10 mmHg
|
|
| ExclusionCriteria |
| Details |
1) Unstable coronary conditions
2) Unstable spinal fracture
3) Lower limb fracture
4) Unstable vitals
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin scale |
Three time points:
Baseline
Discharge
3 months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Mini mental state examination
2) Number and occurrence of cardiopulmonary, musculo-skeletal events during the period (that is complications) |
Three time points:
Baseline
Discharge
3 months follow-up
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Early mobilization following traumatic head injury might allow for possible functional outcome and mobility. This study might provide an insight to rehabilitation experts to plan for early rehabilitation algorithm for people who sustained a traumatic head injury. |