| CTRI Number |
CTRI/2026/03/106360 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of CTAR Exercise on Swallowing Problems in Post-Extubated Patients |
|
Scientific Title of Study
|
Efficacy of Chin Tuck Against Resistance (CTAR) exercise on level of dysphagia among post-extubated patients in selected ICU of a tertiary care hospital, Bhubaneswar- 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 |
Megha Chakraborty |
| Designation |
Post- graduate Student |
| Affiliation |
Kalinga Institute of Industrial Technology |
| Address |
Department of Nursing Sciences, Campus-5, Kalinga Institute of Industrial Technology, Patia, Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
7478220248 |
| Fax |
|
| Email |
meghachakraborty41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asokan R |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Industrial Technology |
| Address |
Department of Nursing Sciences, Campus-5, Kalinga Institute of Industrial Technology, Patia, Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
7008326128 |
| Fax |
|
| Email |
asokanrg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asokan R |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Industrial Technology |
| Address |
Department of Nursing Sciences, Campus-5, Kalinga Institute of Industrial Technology, Patia, Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
7008326128 |
| Fax |
|
| Email |
asokanrg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences (KIMS), KIIT University, Chandaka Industrial Estate, Patia, Bhubaneswar, Odisha, 751024 |
|
|
Primary Sponsor
|
| Name |
MEGHA CHAKRABORTY |
| Address |
Kalinga Institute of Nursing Sciences, Campus- 5, KIIT University, Patia, Bhubaneswar, Odisha, 751024 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 Sujit Kumar Pradhan |
Pradyumna Bal Memorial Hospital |
Critical Care Medicine Department, 5th Floor, Room- Central Intensive Care Unit, Kalinga Institute of Medical Sciences, Campus- 5, KIIT University, Patia, Bhubaneswar, Odisha, 751024
Khordha
ORISSA |
9711360811
dr.pradhansujit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R131||Dysphagia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chin Tuck Against Resistance Exercise |
The experimental group will be provided with the chin tuck against resistance exercise, which includes placing a towel roll of 12.5cm diameter between the chin and the chest area and are instructed to tuck the chin against the towel for 10-30 seconds and repeat it 10 times per set for 5 sets thrice a day for 7 days. Total duration of this intervention is 25- 75 minutes per day for 7 days. |
| Comparator Agent |
Routine Dysphagia Care |
The control group provide routine dysphagia care during 7 days (like clenching teeth, gargling, and side-by-side movement).
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged from 25 to 60 years are post-extubated ICU patients.
Patients a minimum of 6 hours after extubation following at least 48 hours of endotracheal intubation in the ICU of PBMH, Bhubaneswar.
Patient who has an RASS score between 0 and 2 in the post-extubation phase.
Willing to participate in the study.
Ability to comply with the interventions and communications.
|
|
| ExclusionCriteria |
| Details |
Patients who are in tracheostomy.
Patients who have any head and neck injury, chest injury, or rib fracture.
Pre-existing dysphagia due to a pre-existing neurological disorder.
Patients who have GI bleed cases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of chin tuck against resistance exercise on level of dysphagia among post-extubated patient in ICU |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/03/2026 |
| 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="9"
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 randomised controlled pre-test post-test study aims to evaluate the effectiveness of the Chin Tuck Against Resistance (CTAR) exercise on the level of dysphagia among post-extubated ICU patients in a tertiary care hospital in Bhubaneswar. A total of 60 participants (30 intervention, 30 control) will be included based on predefined inclusion and exclusion criteria. The intervention group will perform CTAR exercises using a 12.5 cm towel roll for 5 sets, thrice daily for 7 days, while the control group will receive routine dysphagia care. Swallowing ability will be assessed using standardised tools before and after the intervention. Computerised randomisation and single blinding will be used to reduce bias, and allocation will be concealed using opaque methods. Data will be analysed using descriptive and inferential statistics, including paired and unpaired t-tests. The study is expected to demonstrate a significant improvement in swallowing function among patients receiving CTAR exercises. As a safe, simple, and affordable bedside intervention, CTAR may help accelerate oral intake recovery and reduce dysphagia-related complications in post-extubated ICU patients. |