| CTRI Number |
CTRI/2023/11/059439 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| 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
|
Effect of oropharyngeal exercise therapy on mouth opening, quality of life and sleep quality in post operative oral cancer patients |
|
Scientific Title of Study
|
Effect of Myofunctional therapy on mouth opening, quality of life and sleep quality in post operative oral cancer patients 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 |
Sumeet Nandkumar Keode |
| Designation |
post graduate student |
| Affiliation |
MGM institute of physiotherapy Aurangabad |
| Address |
MGM institute of physiotherapy Aurangabad, N6, Cidco.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9284179304 |
| Fax |
|
| Email |
sumeetkeode123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Dobhal |
| Designation |
Associate professor |
| Affiliation |
MGM institute of physiotherapy Aurangabad |
| Address |
MGM institute of physiotherapy Aurangabad, N6, Cidco.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
santoshdobhal@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Dobhal |
| Designation |
Associate professor |
| Affiliation |
MGM institute of physiotherapy Aurangabad |
| Address |
MGM institute of physiotherapy Aurangabad, N6,Cidco.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
santoshdobhal@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM institute of physiotherapy Aurangabad, N6,Cidco. |
|
|
Primary Sponsor
|
| Name |
Sumeet Nandkumar Keode |
| Address |
Teacher colony, Anjangaonsurji, Amravati, Maharashtra, 444705 |
| 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 Sumeet Keode |
MGM medical college and hospital Aurangabad |
MGM medical college and hospita Gate No.2, MGM Campus, N6, Cidco, Aurangabad,Maharashtra
Aurangabad
MAHARASHTRA |
9284179304
sumeetkeode123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMIOP Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy in mouth cancer patient |
Mandibular exercise.
Self jaw stretch.
Facial muscle movement.
Tongue movement.
AROM of neck. |
| Intervention |
myofunctional therapy (oropharyngeal exercise) |
Phase 1 included :- 4 lip exercises, 5 tongue exercises, 2 jaw exercises, and 2 soft palate exercises. ( 10 days) 10 reps 3 times a day.
Phase 2 included :- 2 lip exercises, 2 tongue exercises, 2 jaw exercises, 5 soft palate exercises, and 2 cheek exercises.( 10 days) 10 reps 5 times a day.
Phase 3 included :- 2 lip exercises, 2 tongue exercises, 1 jaw exercises, and 2 soft palate exercises.( 10 days) 10 reps 5 times a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders.
2. Age group 18-75 years of age.
3. Patient with histopathologically proven oral or oropharyngeal squamous cell carcinoma.(oral cavity, oropharynx, nasopharynx, salivary gland, nasal fossae).
4. Patient who are operatied for an en bloc resection of primary tumor, neck dissection and reconstruction.
5. Patient who is receiving post operative chemotherapy.
6. Difficulty in mouth opening.
7. Patient with sleep disturbed. (insomnia) |
|
| ExclusionCriteria |
| Details |
1. Neurological (facial palsy, cognitive impairment, Alzheimer,senile dementia) or other non tumor related swallowing difficulty.
2. Risk of fracture, respiratory insufficiency (grade3)
3. Intense pain not controlled with analgesic treatment.
4. Bone metastasis with risk of fracture.
5. Patients who are on corticosteroid for more than one month.
6. Psychological reason that could hamper adherence with study protocol.
7. Patient with difficulty with completing questionnaires.
8. Intubated post operative patients. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mouth opening ( THERABITE device)
2. Quality of life (university of Washington quality of life) |
Before and after 0f 4 week intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Subjective sleep quality.(PSQI and consensus sleep diary) |
Before and after 0f 4 week intervention |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/11/2023 |
| 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 Applicable |
| 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 - NO
|
|
Brief Summary
|
Oropharyngeal exercise Oropharyngeal exercises regime is divided into three phases: Phase 1 included :- 4 lip exercises, 5 tongue exercises, 2 jaw exercises, and 2 soft palate exercises. ( 10 days) 10 reps 3 times a day . Phase 2 included :- 2 lip exercises, 2 tongue exercises, 2 jaw exercises, 5 soft palate exercises, and 2 cheek exercises.( 10 days) 10 reps 5 times a day. Phase 3 included :- 2 lip exercises, 2 tongue exercises, 1 jaw exercises, and 2 soft palate exercises.( 10 days) 10 reps 5 times a day.
|