| CTRI Number |
CTRI/2024/03/064060 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the efficacy of Chin-tuck exercise in patients having difficulty in swallowing among stroke patients taking treatment from Neurosciences center, AIIMS, New Delhi |
|
Scientific Title of Study
|
A Randomised Controlled trial to assess the efficacy of Chin-tuck maneuver(CTM) on Neurogenic Dysphagia among stroke patients attending Neurosciences center, AIIMS, New Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu VY |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room number 704, 7th Floor,Neurosciences Centre, Department of Neurology, All India Institute of Medical Sciences, New Delhi PIN CODE- 110029
South
DELHI 110029 India
New Delhi
DELHI
110049
India |
| Phone |
9855480361 |
| Fax |
|
| Email |
vishnuvy16@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Komal |
| Designation |
MSc Nursing (Neuroscience) student |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
komalantil000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Ansari Nagar, AIIMS, New Delhi |
| 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 |
| MsSibi Riju |
NS-4 & NS-5 Ward & Neurology OPD( Room no.-03; Room no.-05;Room no.-29) |
Neuroscience Centre, AIIMS New Delhi
New Delhi
DELHI |
9958879808
sibiriju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, for Post Graduate Research, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I698||Sequelae of other cerebrovasculardiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chin-tuck maneuver |
Total duration of the intervention will be 4 weeks Chin Tuck maneuver
Seated upright in a chair.
A rubber ball with a 12cm diameter is placed between the chin and the base of the neck to provide resistance.
Tuck the chin against the ball and sustain it for 10 seconds (isometric)
Do it for 10 repetitions (isokinetic), three times a day for 4 weeks. |
| Comparator Agent |
Routine Dysphagia treatment |
They will be provided routine treatment for the neurogenic dysphagia that includes OPD consultation and will be observed for 4 weeks on the reduction of dysphagia for make comparison |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with stroke have mild to moderate neurogenic dysphagia as assessed by the GUSS score.
Patients having nasogastric (NG) tube.
Patients are able to communicate properly.
Patients who are cooperative and obey commands.
Patients who are willing to participate in the study.
Patients are having the smartphone. |
|
| ExclusionCriteria |
| Details |
Patients admitted with stroke have severe neurogenic dysphagia as assessed by the GUSS score.
Patients with ET intubation.
Patients who had undergone tracheostomy.
Patients who are unconscious
Patient who has neck or shoulder pain & has limited neck movement. Patient who has disc and cervical spine pain, cervical spine orthosis. Patients with severe dementia or other cognitive impairments, as well as individuals receiving palliative care. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Swallowing ability score as assessed by change in mean FOIS (Functional Oral intake scale) score |
At baseline, week-1, week-2, week-3, week-4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in GUSS score |
At baseline, week-4 |
| Percentage of NG tube removal |
At baseline, week-1, week-2, week-3, week-4 |
|
|
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)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
Stroke is a major global health concern, causing 12.2 million incidents annually and increasing the lifetime risk by 50%. Dysphagia affects 8-45% of stroke patients, leading to longer hospital stays, higher healthcare costs, and long-term institutionalisation. Compensatory swallowing strategies, like the Chin Tuck maneuver, help manage symptoms with dysphagia. The main objective of the study was to assess the efficacy of the Chin-tuck maneuver on the swallowing ability of stroke patients having mild to moderate neurogenic dysphagia in the experimental group. |