| CTRI Number |
CTRI/2020/09/027520 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [OROPHARYNGEAL DYSPHAGIA EXERCISES] |
| Study Design |
Other |
|
Public Title of Study
|
Effectivness of dysphagia exercise on Swallowing Ability among patients with Cerebrovascular Accident |
|
Scientific Title of Study
|
“Effectiveness of Oropharyngeal Dysphagia Exercises on Swallowing Ability among patients with Cerebrovascular Accident in selected tertiary care hospital Bhubaneswar†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sarvendra pratap |
| Designation |
M Sc Nursing student |
| Affiliation |
kalinga institute of nursing sciences |
| Address |
kalinga institute of nursing sciences campus 5
KIIT DU bhubaneswar
kalinga institute of nursing sciences campus 5
KIIT DU bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7980219696 |
| Fax |
|
| Email |
mishrasarvendrapratap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Asokan R |
| Designation |
Associate Professor |
| Affiliation |
kalinga institute of nursing sciences |
| Address |
kalinga institute of nursing sciences campus 5
KIIT DU bhubaneswar
kalinga institute of nursing sciences campus 5
KIIT DU bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9658580055 |
| Fax |
|
| Email |
asokanrg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Asokan R |
| Designation |
Associate Professor |
| Affiliation |
kalinga institute of nursing sciences |
| Address |
kalinga institute of nursing sciences campus 5
KIIT DU bhubaneswar
kalinga institute of nursing sciences campus 5
KIIT DU bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9658580055 |
| Fax |
|
| Email |
asokanrg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga institute of medical sciences,PBMH |
|
|
Primary Sponsor
|
| Name |
Sarvendra pratap |
| Address |
kalinga institute of nursing sciences
bhubaneswar, odisha |
| Type of Sponsor |
Other [there in no sponshership.. i am doing with myself] |
|
|
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 |
| SARVENDRA PRATAP |
Kalinga institute of medical sciences PBMH |
CAMPUS 5 KIIT DU PATIA BHUBANESWAR ODISHA
Khordha
ORISSA |
7980219696
mishrasarvendrapratap@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: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
daily routine care will be given |
daily routine care |
| Intervention |
Effortfull swallowing exercises
Hyoid lift manuever |
for interventional group
1)HYOID LIFT MANEUVER
Purpose: Builds swallowing muscle strength and control
How to Perform:
1.Place multiple small pieces of paper on a towel in front of you. Next,
2.Place a straw in your mouth and suck on the straw,
3.Allowing the paper to get picked up by the tip of the straw.
4.Keep sucking on the straw as you carry the straw over to a cup, and
5.Stop sucking to release the paper into the cup.
6.You should aim to successfully place all of the pieces of paper into the cup.
7.You can start out with just 3 to 5 pieces of paper and slowly increase to around
2)EFFORTFUL SWALLOW
Purpose: Improve the contact and coordination between the different muscles used while swallowing
How to Perform: While dry swallowing,
A.Swallow hard
B.Keep your lips closed tight together
C.Push your tongue against the roof of your mouth when you swallow
D.Do this every time you swallow food or drink or saliva
E.This can also be done as an excercise without food and drink
F.Repeat this up to 10 times in a single session.
after 1 week will done post test afer that comparison will done in between interventiuonal gourp and control group |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age of 20 years to 80 years.
Undrstand Hindi or English or odia.
Willing to participate in the study
Having mild and moderate swallowing difficulty
Available at the time of study.
GCS score of 13-15.
Client who is having CVA |
|
| ExclusionCriteria |
| Details |
Having severe swallowing difficulty.
Having cancer in the esophagus, surgery in the head and neck,
Having congestive heart failure,
Having end stage renal disease.
Pregnant women with CVA
Medicolegal cases
Congenital Maxilofacial Disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Swallowing ability following with Mann Assessment of Swallowing Ability Scoring Scale |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there is no any secondary outcome |
not applicable |
|
|
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)
|
05/09/2020 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a pilot study based in the randomized control trail.with the objective of to assess the swallowing ability before and after Oropharyngeal dysphagia exercise ( Effortfull swallowing exercises and Hyoid lift manuever) among patients with cerebrovascular accident. the exercise will be given for 10-15 minutes of 10-20 repetitions for 2 times a day for 1 week. after that post test will be done
|