| CTRI Number |
CTRI/2025/04/085063 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To find out the combined effect of rTMS and sensory motor stimulation on patients with swallowing difficulty in acute stroke patients |
|
Scientific Title of Study
|
Efficacy of Transcranial Magnetic Stimulation and Sensory Motor Facilitation versus Sham Transcranial Magnetic Stimulation on Dysphagia Severity, Swallowing Ability, and Quality of Life in subjects with Dysphagia due to Acute Stroke - A Randomized Placebo 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 |
Tejaswini Lakde |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College, DMIHER, Sawangi Meghe, Wardha |
| Address |
Neurology ICU, Neurosurgery ICU, Medicine ICU, Neurology ward, Neurosurgery ward, Medicine ward, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
86008800887 |
| Fax |
|
| Email |
tejaswinilakde86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Irshad Qureshi |
| Designation |
Professor of Neurophysiotherapy department |
| Affiliation |
Ravi Nair Physiotherapy College, DMIHER, Sawangi Meghe, Wardha. |
| Address |
Neurology ICU, Neurosurgery ICU, Medicine ICU, Neurology ward, Neurosurgery ward, Medicine ward, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejaswini Lakde |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College, DMIHER, Sawangi Meghe, Wardha. |
| Address |
Neurology ICU, Neurosurgery ICU, Medicine ICU, Neurology ward, Neurosurgery ward, Medicine ward, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8600880087 |
| Fax |
|
| Email |
tejaswinilakde86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe, Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe, Wardha, Maharashtra, India 442001 |
| 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 |
| Dr Tejaswini Lakde |
Acharya Vinoba Bhave Rural Hospital |
Neurology ICU, Neurosurgery ICU, Medicine ICU, Neurology ward, Neurosurgery ward, Medicine ward, Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)Sawangi Meghe, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA |
8600880087
tejaswinilakde86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I698||Sequelae of other cerebrovasculardiseases, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL PHYSIOTHERAPY |
SENSORY INTERVENTION
a. Thermal tactile stimulation
Complete five strokes along each arch followed by a saliva swallow
Perform once to twice daily
MOTOR
INTERVENTIONS
A. Mendelsohn maneuverer
Swallow normally. Perform the exercise 10 times per set 1-2 sets per day.
B. Masako maneuverer
Hold Perform the exercise 10 times per set and 1-2 sets per day.
C. Oromotor Control Exercise Move in each direction 5-10 times.
Perform three to five sets per day.
D.Oropharyngeal
strengthening exercises Hold the pushing or pulling position for clinicians finger Push the tongue firmly a few seconds.
Perform each exercise 5-10 times. Push the tongue Perform three to five sets per day.
SHAM TMS
30 minutes |
| Intervention |
Repetitive Transcranial magnetic stimulation and sensory motor facilitation |
SENSORY INTERVENTION
a. Thermal tactile stimulation
Complete five strokes along each arch followed by a saliva swallow
Perform once to twice daily
MOTOR
INTERVENTIONS
A. Mendelsohn maneuverer
Swallow normally. Perform the exercise 10 times per set 1-2 sets per day.
B. Masako maneuverer
Hold Perform the exercise 10 times per set and 1-2 sets per day.
C. Oromotor Control Exercise Move in each direction 5-10 times.
Perform three to five sets per day.
D.Oropharyngeal
strengthening exercises Hold the pushing or pulling position for clinicians finger Push the tongue firmly a few seconds.
Perform each exercise 5-10 times. Push the tongue Perform three to five sets per day.
REPETITIVE TMS
30 minutes |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with ischemic or haemorrhagic stroke who are in acute phase (2-4
weeks of onset).
2. Presence of dysphagia secondary to stroke, referred by ENT department, Neurology
department to neurophysiotherapy department
3. No swallowing disorder attributed to conditions other than stroke.
4. Subjects who are willing to participate in the study
5.Subjects who are conscious, oriented and co-operative.
6. Subjects with GCS scoring more than 12. |
|
| ExclusionCriteria |
| Details |
1. Subjects with recurrent stoke.
2. Subjects with trauma, infections, recently operated.
3. Subjects with on external appliance that is mechanical ventilator, endotracheal tube
tracheostomy tube.
4. Subjects with sensory loss, cognitive impairment.
5. Subjects with epilepsy.
6. Subjects with intracranial metallic implants and pacemakers.
7. Hemodynamically unstable subjects.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mann Assessment of Swallowing Ability (MASA)
2. Dysphagia Outcome and Severity Scale (DOSS) |
Baseline to 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Swallowing Quality of Life (SWAL-QOL) scale |
Baseline to 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tejaswinilakde86@gmail.com].
- For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Stroke is a leading cause of disability worldwide, and dysphagia (difficulty swallowing) is a
common and debilitating complication. Current treatments for post-stroke dysphagia, such as
traditional swallowing therapy, often have limited success.
Stoke with severe dysphagia has a devastating impact on quality of life as it can eliminate the
pleasure of eating and drinking. It is associated with significant morbidity and mortality
including dehydration, malnutrition, airway obstruction, and aspiration pneumonia. Less
recognized is the impact of dysphagia on psychosocial functions. It can lead to isolation as the
patient withdraws from activities involving food such as family mealtimes, group dinners, and
teatime.
The earlier studies have focused on either oropharyngeal muscle re-education and
strengthening or non-invasive brain stimulation (NIBS) such as rTMS separately but not in combined form. Sensory motor stimulation and rTMS may work together to enhance
neuroplasticity, promoting the formation of new neural connections and facilitating recovery
of swallowing function. This combined approach may lead to improved clinical outcomes, such
as reduced aspiration risk, improved nutritional status, and enhanced quality of life for stroke
survivors with dysphagia.
Hence to find out the effectiveness of rTMS over sham TMS on clinical outcomes in subjects
with dysphagia in acute stroke has to be conducted. |