| CTRI Number |
CTRI/2020/05/025356 [Registered on: 26/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effect of feedback based therapy for swallowing difficulty following stroke |
|
Scientific Title of Study
|
Efficacy of feedback based therapy for dysphagia in post stroke patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R P SHANMUGA PRIYA |
| Designation |
PHYSIOTHERAPIST |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
PORUR.
PORUR
Chennai
TAMIL NADU
600116
India |
| Phone |
9629398757 |
| Fax |
|
| Email |
rpshanmugapriyapt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A RAJARAJESWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
PORUR CHENNAI
PORUR
Chennai
TAMIL NADU
600116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
araji21@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
A RAJARAJESWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
PORUR CHENNAI
PORUR
Chennai
TAMIL NADU
600116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
araji21@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
PORUR |
| 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 |
| SHANMUGA PRIYA |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
PORUR, CHENNAI,600116
Chennai
TAMIL NADU |
9629398757
rpshanmugapriyapt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECT, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI, 600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G46||Vascular syndromes of brain in cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL THERAPY |
ELECTRICAL STIMULATION AND SWALLOWING EXERCISES |
| Intervention |
VISUAL, AUDITORY AND TACTILE FEEDBACK BASED THERAPY FOR DYSPHAGIA REHABILITATION |
DYSPHAGIA REHABILITATION IN POST STROKE CONSISTING OF VISUAL, AUDITORY AND TACTILE FEEDBACK BASED THERAPY PROGRAM INCORPORATING sEMG BIOFEEDBACK |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Medically stable
complaints of swallowing and non-oral feeding
Functional oral intake scale less than or equal to two
Mini-mental state examination score of 21 or more than 21
|
|
| ExclusionCriteria |
| Details |
Neurological disease other than stroke
Impaired communication ability
Upper gastrointestinal disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Oral Intake Scale |
10 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EMG MUSCLE ACTIVITY OF SUPRAHYOID MUSCLES |
10 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/05/2020 |
| Date of Study Completion (India) |
12/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an experimental study; participants blinded, A clinical trial to study the effectiveness of feedback based therapy for dysphagia in post stroke. this study will be conducted in Sri Ramachandra Institute of Higher Education And Research, Porur, Chennai, India. Patients who meet the inclusion criteria will be recruited and allocated into control and interventional group. Informed consent will be obtained. Detailed swallowing evaluation using Functional Oral Intake Scale(FOIS), Number of days of Nasogastric tube dependence and EMG muscle activity will be obtained before and after therapy. Interventional group will be receiving Feedback based therapies along with conventional therapy and control group will be receiving conventional therapy. The duration of the treatment will be for 10 days. On completion of treatment duration, the post interventional outcome will be evaluated using FOIS and pre and post EMG activity of suprahyoid muscle will compared to obtain the result of the study. |