| CTRI Number |
CTRI/2021/12/039029 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
24/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of CTAR exercise in improving swallowing capacity among stroke patients with swallowing difficulty. |
|
Scientific Title of Study
|
Effect of Chin Tuck Against Resistance (CTAR) exercise in improving swallowing capacity among stroke patients with dysphagia: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha S |
| Designation |
Msc Medical surgical nursing student |
| Affiliation |
College of Nursing, JIPMER, Puducherry- 605006 |
| Address |
M.SC NURSING, Medical surgical department, college of nursing, JIPMER
Room: 317, M.SC NURSING student, Medical Surgical Department, college of nursing, JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9047526106 |
| Fax |
|
| Email |
kavisubbu288@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MJ Kumari |
| Designation |
Professor.cum,Principal (Ag) |
| Affiliation |
College of Nursing, Jawaharlal Institute Of Postgraduate Medical Education & Research, Puducherry |
| Address |
Nursing department, College of Nursing, Jawaharlal Institute Of Postgraduate Medical Education & Research, Puducherry
Nursing department, College of Nursing, JIPMER,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramkumar Sugumaran |
| Designation |
Assistant professor |
| Affiliation |
Neurology department, Jawaharlal Institute Of Postgraduate Medical Education & Research, Puducherry |
| Address |
Assistant professor,
Department of Neurology,
JIPMER, puducherry
Assistant professor,
Department of Neurology,
JIPMER, puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894891561 |
| Fax |
|
| Email |
ramkumar.sugumaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| intra mural fund, JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH, Puducherry. |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Intramural fund committee, JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH, PUDUCHERRY- 605006. |
| 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 |
| Dr MJ Kumari |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH |
Department of Neurology, SSB building, JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH, GOrimedu, PUDUCHERRY- 605006.
Pondicherry
PONDICHERRY |
9894595420
kumari_mj@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee for human studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, (2) ICD-10 Condition: I61||Nontraumatic intracerebral hemorrhage, (3) ICD-10 Condition: I60||Nontraumatic subarachnoid hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CTAR exercise with conventional therapy |
The CTAR exercise will be performed in two types Isometric (sustained CTAR) and Isotonic exercises (repetitive CTAR).
In isometric CTAR, the patients are asked to sit upright and hold the ball under the chin. Sustain chin tuck against inflatable rubber ball as hard as possible; do it for 3 times without repetition.
In isotonic CTAR, the patients are asked to sit upright and hold the ball under the chin. Tuck the chin, as hard as possible against the ball; then lift the chin. Perform this for 30 consecutive repetitions. These two exercises are performed twice a day.
|
| Comparator Agent |
only conventional therapy |
patients will receive normal treatment and perform only conventional therapy such as alternate lip movement, lip seal achievement, tongue-elevation, protrusion and lateral movement of tongue, pharyngeal stimulation for 30 mins/day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Stroke patients within 6 months
Patients with Dysphagia following stroke confirmed by gugging swallowing scale (GUSS->9 score)
The patients were able to swallow voluntarily
Patient who is able to sit without assistance
Patient who will have the ability to perform chin tuck using rubber ball
|
|
| ExclusionCriteria |
| Details |
Patients with unstable condition
Patients with previous abnormality in mouth, throat and neck
Patients with multiple organ dysfunction syndrome
Uncooperative patients
Patients with global aphasia or sensory aphasia
Patients with the risk of aspirating the barium swallow (GUSS score 0-9 )
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improve the swallowing capacity and reduce the aspiration |
After 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduce the chance of aspiration pneumonia |
after 14 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/01/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - nil
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response (Others) - nil
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 01-12-2022 and end date provided 01-12-2025?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This CTAR exercise will improve the swalloeing ability by regenerating the new neuroplasticity and prevents from aspiration. |