| CTRI Number |
CTRI/2025/07/090801 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study on the Effectiveness of Head Lift Exercise in Reclined Position versus Chin Tuck Against Resistance in Post-Stroke Dysphagia Patients |
|
Scientific Title of Study
|
Effectiveness of Head Lift Exercise With Recline Position Versus Chin Tuck Against Resistance Among Post-Stroke Dysphagia Patients – A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Tanvi Alpeshbhai |
| Designation |
PG Schalor |
| Affiliation |
KPGU, Vadodara |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat
Vadodara
GUJARAT
391243
India |
| Phone |
9824792981 |
| Fax |
|
| Email |
pateltanvi4202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragna Landge PT |
| Designation |
Assosciate Professor |
| Affiliation |
KPGU, Vadodara |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat
Vadodara
GUJARAT
391243
India |
| Phone |
7861805233 |
| Fax |
|
| Email |
pragnalandge.kspr@kpgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragna Landge PT |
| Designation |
Assosciate Professor |
| Affiliation |
KPGU, Vadodara |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat
Vadodara
GUJARAT
391243
India |
| Phone |
7861805233 |
| Fax |
|
| Email |
pragnalandge.kspr@kpgu.ac.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD, Matrushri Davalba Hospital, Vadodara ,Gujarat, India ,391243 |
|
|
Primary Sponsor
|
| Name |
Patel Tanvi Alpeshbhai |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat,India,391243 |
| Type of Sponsor |
Other [Self] |
|
|
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 Patel Tanvi Alpeshbhai PT |
Physiotherapy OPD, Matrushri Davalba Hospital |
Krishna Edu Campus, Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT |
9824792981
pateltanvi4202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health Research, KPGU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R131||Dysphagia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CHIN TUCK AGAINST RESISTANCE |
The patient will be seated in a chair. The therapist will give a rubber ball and instruct them on performing Chin Tuck Against Resistance exercise, which include the following:
Isometric Exercise: The patient will look at their toes without raising their shoulders and hold this position for 1 minute. This sequence will be repeated three times, with 60-second rests between each repetition.
Isotonic Exercise: The patient to look at their toes without holding or raising their shoulders. This exercise will be performed 10–30 times consecutively without will be placed rest.3 times a day for 5 days a week for 4weeks |
| Intervention |
HEAD LIFT EXERCISE WITH RECLINE POSITION |
In supine position. A wedge pillow behind the patient’s head, back, and shoulder. The patient performs head lift exercises, which include the following:
Isometric Exercise: The patient will look at their toes without raising their shoulders and hold this position for 1 minute. This sequence will be repeated three times, with 60-second rests between each repetition.
Isotonic Exercise: 10–30 times consecutively without will be placed rest.3 times a day for 5 days a week for 4weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with stroke with less than 3 months of onset.
2. Age group between 20 to 70 years
3. Patient with oropharyngeal dysphagia after stroke confirmed by VFSS.
4. Patient with grade 3 MMT of head and neck. Patient is willing to participate in the study and cooperate throughout the session.
5. MMSE score more than 24
6. Patient is willing to participate in the study and cooperate throughout the session. |
|
| ExclusionCriteria |
| Details |
1. Patient who has a neck, back and shoulder pain. Those with cervical herniated nucleus, cervical spine orthosis, cervical and spine surgery, oral surgery and congenital neck anatomy
2. Those who had undergone tracheostomy.
3. surgical procedures of the strap muscles.
4. The patient with history of myositis, dystrophy, myasthenia gravis, and head and neck cancer.
5. Cricopharyngeal dysfunction. And Communication problems. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Eating Assessment Tool (EAT-10) score |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Oral Intake Scale |
4 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/07/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 common post-stroke complication that adversely affects quality of life. Targeted rehabilitation exercises like the Head Lift in a reclined position and Chin Tuck Against Resistance have shown promise in improving swallowing function. These non-invasive interventions aim to strengthen and coordinate the swallowing muscles. This study evaluates the relative effectiveness of both exercises in managing stroke-related dysphagia, aiming to inform clinical practice and enhance patient outcomes. Null Hypothesis: There is no significant difference in the effectiveness of the Head Lift and CTAR exercises for post-stroke dysphagia patients. Alternate Hypothesis: There is a significant difference in the effectiveness of the Head Lift and CTAR exercises for post-stroke dysphagia patients. |