| CTRI Number |
CTRI/2024/01/061054 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| 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
|
Comparative effect of Proprioceptive Neuromuscular Facilitation and Chin Tuck against Resistance in post stroke Dysphagia- A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative effect of Proprioceptive Neuromuscular Facilitation and Chin Tuck against Resistance in post stroke Dysphagia: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragati Chhajed |
| Designation |
Post Graduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar floor, Advanced Physiotherapy Center
Room No 39
Dr Prabhakar kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
08180055927 |
| Fax |
|
| Email |
pragatichhajed10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeba Chitra |
| Designation |
Head of Department and Professor of Neuro Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar floor, Advanced Physiotherapy Center
Room No 39
Dr Prabhakar kore Hospital and MRC, Belagavi
Sagar floor, Advanced Physiotherapy Centre, Room no 39, KLE Dr. Prabhakar Kore hospital and MRC, Belagavi, Karnataka, 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9886510290 |
| Fax |
|
| Email |
jebachitra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragati Chhajed |
| Designation |
PG student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar floor, Advanced Physiotherapy Center
Room No 39
Dr Prabhakar kore Hospital and MRC, Belagavi
Sagar floor, Advanced Physiotherapy Center
Room No 39
Dr Prabhakar kore Hospital and MRC, Belagavi, Karnataka- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8180055927 |
| Fax |
|
| Email |
pragatichhajed10@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and Resesarch Centre, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Pragati Chhajed |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE Dr Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, 590010 |
| Type of Sponsor |
Other [Self Sponspored] |
|
|
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 |
| Pragati Chhajed |
KLE Dr Prabhakar Kore Hospital and MRC |
JNMC campus, Nehru nagar, Belagavi 590010, Karnataka
Belgaum
KARNATAKA |
08180055927
pragatichhajed10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chin Tuck Against Resistance |
The patient will carry out
this exercise while sitting upright on a chair, tucking the chin down towards
the manubrium sterni. The manubrium sterni will be compressed while an
inflatable rubber ball is put between them, giving the workout with the
necessary resistance. The exercise will be done in one set per day (30
reps/set), four days a week, for three weeks |
| Comparator Agent |
Control group |
No exercises will be given |
| Intervention |
Proprioceptive Neuromuscular Facilitation |
Patients are instructed to move their heads in a diagonal
motion with their mouths open against resistance from the end of the
extension-left rotation to the end of the flexion-right rotation. At the
conclusion of the movement, they are instructed to hold the position for six
seconds against resistance (stabilising contractions) while seated upright.
The physiotherapist will then reposition the patients head and mouth back to
their starting positions as the patient tries to maintain their position
(eccentric contraction). For three weeks, the exercise will be done four days
a week for one set per day (30 repetitions/set). |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Post stroke patients having Dysphagia measured using Food Intake LEVEL
scale
Post-Stroke patients aged over 19 years, considering all genders
Mini Mental State Examination score of ≥ 24
Patients with GCS score of >13
Patients with good Head/ Trunk Control
Patients with Ryles tube |
|
| ExclusionCriteria |
| Details |
ï‚· Unconscious or comatose patients
ï‚· History of neck surgery, head and neck cancer or any associated neck
injuries
ï‚· Neck pain or radiculopathy
ï‚· Inadequate head control/ trunk control
ï‚· Patients with Tracheostomy tube |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
. Water swallowing test (WST)
Food Intake Level Scale (FILS)
Dysphagia Handicap Index (DHI) |
T1 - 0 weeks
T2 - 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dysphagia Handicap Index (DHI) |
T1 - 0 weeks
T2 - 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Dysphagia is a commonly documented morbidity post stroke.
Its reported prevalence is widely discrepant, ranging between 19% and 81%
In a study conducted by Sayaca et al., Proprioceptive Neuromuscular Facilitation
technique was effective in improving swallowing function in patients with
Dysphagia.
Similarly Chin Tuck Against Resistance(CTAR) exercise activates the suprahyoid
muscle and is an effective therapeutic exercise for improving swallowing function
in patients with dysphagia and less strenuous than Shaker exercise .
This study aims to compare and evaluate the effect of PNF and Chin Tuck Against
Resistance exercise in post stroke patients with Dysphagia. |