| CTRI Number |
CTRI/2025/10/095953 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Rehabilitative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on nurse-assisted exercises to make swallowing easier for stroke patients |
|
Scientific Title of Study
|
Effectiveness of nurse-assisted oro-pharyngeal exercises on oropharyngeal function among post-stroke dysphagia patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BARSHA NANDI |
| Designation |
Msc Nursing student |
| Affiliation |
College of Nursing , AIIMS Bhubaneswar |
| Address |
LT- 5,2nd floor, Neuroscience Nursing, College of Nursing , AIIMS Bhubaneswar,Sijua, Patrapada, Bhubaneswar, Odisha 751019,India
Khordha
ORISSA
751019
India |
| Phone |
6296402445 |
| Fax |
|
| Email |
barshanandi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Anand |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing , AIIMS Bhubaneswar |
| Address |
Room no - 115,1st floor,College of Nursing , AIIMS Bhubaneswar,Sijua, Patrapada, Bhubaneswar, Odisha 751019,India
Khordha
ORISSA
751019
India |
| Phone |
9612681996 |
| Fax |
|
| Email |
con_anand@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Anand |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing , AIIMS Bhubaneswar |
| Address |
Room no 115 , 1st floor , College of Nursing , AIIMS Bhubaneswar,Sijua, Patrapada, Bhubaneswar, Odisha 751019,India
Khordha
ORISSA
751019
India |
| Phone |
9612681996 |
| Fax |
|
| Email |
con_anand@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Sijua, Patrapada,Bhubaneswar,Odisha,India, 751019 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 L Anand |
AIIMS BHUBANESWAR |
Neurology ward H3, AIIMS Bhubaneswar,Sijua, Patrapada, Bhubaneswar, Odisha ,India, 751019,India
Khordha
ORISSA |
9612681996
con_anand@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse assisted oropharyngeal exercises |
Demonstration of Oropharyngeal exercise by speech therapist on allocation. It involves active and passive exercise. Nurse investigator assists the patient to perform.
On day 2 onwards, the exercise program will be administered to the patient by the investigator. It includes supervision of exercise performance and assisting the patient to perform the exercise by investigator on daily basis. There may be random visits of speech therapists during the intervention.
The intervention will be provided for 10 days or till the patient is discharged from the ward, whichever is earlier.
The group will receive 15 mins intervention each time and 3-4 times per day.
The swallowing trial will be conducted at end of the intervantion .
|
| Comparator Agent |
Oropharyngeal exercises |
The control group will receive same intervention trained by speech therapist and assisted by family members. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Post stroke patient
Able to understand and perform exercise
Moderate to Severe dysphagia ( GUSS score less than 15)
All types of stroke irrespective of type of stroke, location and management.
|
|
| ExclusionCriteria |
| Details |
Patients undergone glossectomy.
Patients those are not able to swallow due to other surgeries.
Patients those who have tracheostomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progress in swallowing as evidenced by GUSS score. |
10 days or till the patient will be discharge from the ward, whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
By day 10 or upon discharge from the ward, whichever takes place first |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study aims to evaluate the effectiveness of nurse-assisted oro-pharyngeal exercises in improving oropharyngeal function among post-stroke dysphagia patients.The study also assesses patient satisfaction with the exercises. It is based on the assumption that guided oro-pharyngeal exercises can enhance swallowing ability, prevent complications, and improve overall quality of life in post-stroke patients. |