| CTRI Number |
CTRI/2026/01/102157 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of musculoskeletal impairment in oral cavity cancer |
|
Scientific Title of Study
|
Prevalence of musculoskeletal impairments after surgical and or radiation therapy among patients with oral cavity cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Anusha K |
| Designation |
Postgraduate Student (MPT – Oncology Physiotherapy) |
| Affiliation |
Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India |
| Address |
Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9344280274 |
| Fax |
|
| Email |
anushakuppan153@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mrs. Arockia Pramila .C |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India |
| Address |
Department of Physiotherapy,
Sri Ramachandra Faculty of Physiotherapy,
Sri Ramachandra Institute of Higher Education and Research,
No.1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636306 |
| Fax |
|
| Email |
arockiaarul@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Anusha K |
| Designation |
Postgraduate Student (MPT – Oncology Physiotherapy) |
| Affiliation |
Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India |
| Address |
Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9344280274 |
| Fax |
|
| Email |
anushakuppan153@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Hospital,
No:1 ,Sri Ramachandra nagar,
Sri Ramachandra Institute of Higher Education and Research (DU),
porur ,chennai-116. |
|
|
Primary Sponsor
|
| Name |
ANUSHA K |
| Address |
Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai. |
| Type of Sponsor |
Other [] |
|
|
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 Anusha K |
Sri Ramachandra Hospital |
Department of Surgical oncology and Department of Radiation oncology, OPD -2nd floor,No:1, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU |
9344280274
anushakuppan153@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients with a diagnosis of oral cavity cancer who underwent surgery, combination of surgery and radiation therapy.
Adults 30 to 70years who are diagnosed to have oral cavity cancer with stage I to stage III without metastasis (as per the TNM classification system of malignant tu |
|
| ExclusionCriteria |
| Details |
A patient with oral cavity cancer who would be treated with only chemotherapy
• TMJ disorders, infection, or congenital anomalies
• Non-cooperative patient
• Immediate postoperative patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the impairment after surgical and radiation treatment in patients with oral cavity cancer patient
To identify the most prevalent impairment among neck dysfunction, shoulder dysfunction, and trismus. |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analyse the association of such impairments with variables of intervention for oral cavity cancer |
6 month |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
16/02/2026 |
| 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="6"
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
|
STUDY PROCEDURE: Patients who have undergone surgery and radiation therapy for oral cavity cancer will be recruited from the surgical and radiation oncology departments. Participants will be selected based on specific inclusion criteria. After obtaining informed consent, participants will undergo a comprehensive assessment. Assessment Components The assessment will include: 1. Demographic and Clinical Data Collection: Gathering information on patient demographics and clinical characteristics, such as: - Type of surgery performed - Date of surgery - Radiation therapy status 2. Movement Impairment Evaluation: Each patient will be evaluated for movement impairments, including: - Trismus: Limited mouth opening, assessed using maximal interincisal opening (MIO) - Shoulder Dysfunction: Limited shoulder mobility, assessed using shoulder range of motion - Neck Dysfunction: Limited neck mobility, assessed using cervical range of motion This assessment aims to gather valuable information on the impact of surgery and radiation therapy on patients’ movement and functional abilities, which can inform rehabilitation strategies and improve patient outcomes OUTCOME MEASURE Goniometer Inclinometer Thera bite |