CTRI

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CTRI Number

CTRI/2024/07/070531 [Registered on: 12/07/2024] Trial Registered Prospectively

Last Modified On:

11/07/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Structured early mobilization protocol on ICU health related parameters in traumatic brain injury patients.

Scientific Title of Study

Immediate impact of a structured early mobilization protocol on ICU mobility, length of stay in the ICU and duration of ventilatory support in patients with moderate to severe traumatic brain injury:A randomized controlled trial

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Yamini Mayur Dhond
Designation	Master of Physiotherapy student
Affiliation	Institute of Physiotherapy Srinivas University.
Address	Department of Physiotherapy Institute of Physiotherapy Srinivas University,Pandeshwar, Mangalore, Dakshina kannada, Karnataka. Dakshina Kannada KARNATAKA 575001 India
Phone	8767379440
Fax
Email	yaminimdhond@gmail.com

Details of Contact Person
Scientific Query

Name	M. Premkumar
Designation	Associate Proffesor
Affiliation	Institute of Physiotherapy ,Srinivas University.
Address	Department of Physiotherapy,Institute of Physiotherapy, Srinivas University,Pandeshwar, Mangalore, Dakshina kannada, Karnataka. Dakshina Kannada KARNATAKA 575001 India
Phone	9442508754
Fax
Email	80pk2009@gmail.com

Details of Contact Person
Public Query

Name	Yamini Mayur Dhond
Designation	Master of Physiotherapy student
Affiliation	Institute of Physiotherapy,Srinivas University.
Address	Department of Physiotherapy,Institute of Physiotherapy,Srinivas University ,Pandeshwar, Mangalore, Dakshina kannada, Karnataka. Dakshina Kannada KARNATAKA 575001 India
Phone	8767379440
Fax
Email	yaminimdhond@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Yamini Mayur Dhond
Address	Department of Physiotherapy,Institute of Physiotherapy,Srinivas University ,Pandeshwar, Mangalore, Dakshina Kannada, Karnataka.
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DrYamini Mayur Dhond	INSTITUTE OF PHYSIOTHERAPY, SRINIVAS UNIVERSITY.	Department of Physiotherapy,Institute of Physiotherapy,Srinivas University ,Pandeshwar, Mangalore, Dakshina Kannada, Karnataka. Dakshina Kannada KARNATAKA	8767379440 yaminimdhond@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SRINIVAS UNIVERSITY ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: S062\|\|Diffuse traumatic brain injury,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Early mobilization	1time for 5-45 minutes for 7daysThe intervention will be given within 72hours of ICU admission of the patient till the discharge of the patient from the ICU.
Comparator Agent	Routine physiotherapy treatment	1 time for 7 days for 5-45 minutes,The routine physiotherapy treatment will commense once the patient is reffered to physiotherapy treatment.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	1.Moderate to severe Traumatic brain injury(TBI) assessed using the Glasgow Coma Scale(GCS) of 6-13 in the ICU. 2.With or without craniotomy 3.Patients on assisted ventilation IMV,CPAP and PEEP modes of ventilator dependent patients.

ExclusionCriteria

Details

Patients with age less than 18 years
Mild Traumatic brain injury(TBI) patients with Glasgow Coma Scale(GCS) less than 8
Pregnancy
Vegetative state
Patients with fracture of the pelvic bone,severe cardiac arrhythmias,and seizures which are not controllable.
Patients on assisted ventilation CMV mode of ventilator dependent patients.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Perme ICU mobility score Richmond Agitation Sedation Scale (RASS)	1st day, 7th day

Secondary Outcome

Outcome	TimePoints
1)Length of ICU stay in the hospital 2) Duration of ventilator support	First and last day of intervention

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
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)

22/07/2024

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="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

The study aims to evaluate the immediate impact of a structured early mobilization protocol on ICU mobility, length of ICU stay (LOS), and duration of ventilator support in patients with moderate-to-severe traumatic brain injury (TBI), using the Perme ICU Mobility Score. It seeks to compare this protocol with conventional routine physiotherapy.

Objectives:

Analyze the impact of conventional physiotherapy on ICU mobility, LOS, and ventilator support duration.

Analyze the impact of structured early mobilization on the same parameters.

Compare the two approaches.

The study is expected to improve patient outcomes, potentially reducing ICU stay and ventilator support needs. Subjects from Srinivas Medical Sciences Hospital, Mangalore, will be included after ethical approval. They will be randomized into two groups: Group A (intervention) following a structured protocol and Group B (control) receiving routine physiotherapy. Pre-intervention assessments will use the Perme ICU Mobility Score and Richmond Agitation Sedation Scale (RASS).