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CTRI Number  CTRI/2025/09/094782 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 03/02/2026
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   Effectiveness of Rocabado approach and Shaker exercise on functionality and QOL in patients with Oral Cancer 
Scientific Title of Study   A Randomized Controlled Trial to evaluate effectiveness of Rocabado approach and Shaker exercise on functionality and QOL in patients with Oral Cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanushree patil  
Designation  Community Physiotherapy Resident 
Affiliation  Dr APJ AK College of physiotherapy Loni ahmadnagar 
Address  04 manisha state bank colony Jalgaon
Pravara institute of medical science,loni ahmadnagar
Jalgaon
MAHARASHTRA
425001
India 
Phone  09834908838  
Fax    
Email  tanup1824@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepali Hande PT 
Designation  Head of Community Physiotherapy Dept,Professor 
Affiliation  Dr APJ AK College of physiotherapy Loni ahmadnagar 
Address  404 community physiotherapy ,Dr. APJ Abdul kalam college of physiotherapy,Pravara institute of medical science,loni ahmadnagar0
Pravara institute of medical science,loni ahmadnagar
Jalgaon
MAHARASHTRA
413736
India 
Phone  09834908838  
Fax    
Email  deepali.hande@pmt.pims.org  
 
Details of Contact Person
Public Query
 
Name  Tanushree patil  
Designation  Community Physiotherapy Resident 
Affiliation  Dr APJ AK College of physiotherapy Loni ahmadnagar 
Address  04 manisha state bank colony Jalgaon
Pravara institute of medical science,loni ahmadnagar
Jalgaon
MAHARASHTRA
425001
India 
Phone  09834908838  
Fax    
Email  tanup1824@gmail.com  
 
Source of Monetary or Material Support  
Dr APJ AK College of physiotherapy Pravar institute of medical science,loni,413736,ahmadnagar 
 
Primary Sponsor  
Name  Dr APJ AK College of physiotherapy 
Address  Community Physiotherapy dept Pravara institute of medical science ,loni 413736,ahmadnagar 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
community department Dr Apj ak college of physiotherapy  Pravara institute of medical science ,loni ahmadnagar 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrTanushree patil PT  Dr APJ AK College of physiotherapy,loni,ahmednagar 413736  pravara institute of medical science,loni ahemadnagar
Ahmadnagar
MAHARASHTRA 
09834908838

tanup1824@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Pravara institute of medical science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  In the control group there will be regular protocol of treatment while in intervention group rocabado appraoch, shakers manuever  In the control group there will be regular protocol of treatment while in intervention group rocabado appraoch, shakers manuever 
Intervention  Rocabado exercise, shakers manuever  Rocabado Exercises This exercise program is given to patients with post traumatic temporomandibular joint TMJ problems or with recent onset dysfunction that is largely posture related These patients will generally progress quickly Once existing mechanical dysfunctions are corrected the emphasis of treatment can shift to education on the maintenance of good posture and oral habits Exercise Techniques Rocabado’s 6x6 Exercise Program Rocabado advocates the instruction of six fundamental components of activity for the treatment of TMJ dysfunction It is recommended that patients complete each activity six times per session and six times per dayThe Shaker Exercise The Shaker exercise is a neck exercise that strengthens the suprahyoid muscles to improve swallowing It involves a series of sustained and repetitive head lifting exercises to enhance the strength of infrahyoid and suprahyoid muscular activity It includes both isometric and isotonic exercises Isometric exercises are performed by raising the head up for sixty seconds followed by a one minute rest repeated three times After this isotonic exercises are performed with thirty repetitions of alternate up and down movement of the head This enhances the contraction of the thyrohyoid muscle strengthens the suprahyoid muscles facilitates the upward and forward movement of the larynx and thereby opens the upper esophageal sphincter 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Individuals undergone with post-operative oral cancer surgery

 
 
ExclusionCriteria 
Details  Individuals with any history of recent fracture nasal bone fracture, maxillary or mandible,
Neurological or neuromuscular disease metabolic, myopathies or myasthenia gravis,
Individuals not willing to participate
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cervical and tmj range of motion assessment  Baseline measurements,and the of end treatment of 6week  
 
Secondary Outcome  
Outcome  TimePoints 
Test of Masticating & Swallowing Solids,Oral Health Quality of Life,Visual analogue scale  Baseline measurements,and the of end treatment of 6week  
Test of Masticating & Swallowing Solids,Visual Analogue Scale,Oral Health Quality of Life,  Baseline measurementsand the of end treatment of 6week  
 
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 1 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="30" 
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
Modification(s)  

Oral cancer is an umbrella term for malignant mouth tumors including the buccal mucosa the front two thirds of the tongue the hard palate the floor of the mouth the lips or the gums Nowadays cancer is the most prevalent disease affecting humans Dr Mariano Rocabado has extensively studied TMD and developed a exercise program which means that there are 6 types of exercises which are to be performed 6 times in a day with 6 repetitions of each exercise that plays a crucial role in treating Temporomandibular joint disorder These 6 exercises are rest position of the tongue shoulder posture correction stabilization of head flexion axial extension of the neck controlled TMJ rotation and rhythmic stabilization technique which emphasized on the head to neck neck to shoulder and lower jaw to upper jaw postural relationships Rocabados approach comprises of Rocabado exercises and TMJ manipulation The purpose of TMJ manipulation is to help relieve the tension from the soft tissues and to normalize the ROM in the jaw neck and head covering this entire region The Rocabado exercise programme has also been found to be beneficial in reducing pain and increasing masticatory muscle function as well as improving forward head posture restoring restricted joint mobility muscle length limitation and postural and functional limitations

Need for the study Oral cancer is the sixth most frequent cancer in the world It is responsible for one fourth of male and one tenth of female malignancies in India Due to widespread tobacco chewing and smoking practices oral cancer is very prevalent in India The most frequent postoperative oral crises include restricted mouth mobility chest discomfort and dyspnea edema trouble eating and impaired speech dysarthria and patients with head and neck cancer frequently experience restricted mouth opening also known as trismus and limitations on activity around the surgical area Difficulty eating and swallowing food dysphagia can have a significant impact on a patients life after radiation treatment and surgery Physiotherapy may benefit those with oral cancer who are receiving treatment alternatives including head and neck exercises mouth opening exercises by utilizing therapeutic equipment and a mouth proprioceptive neuromuscular facilitation approach The main goal of a physiotherapy treatment program for postoperative patients is to help them regain functional range of motion ROM and so enhance their quality of life

The Rocabado approach indicates that the centric orientation is only possible when the position and movement patterns of the subcranial area the mid and lower cervical spine the hyoid and the jaw are in balance Because these impacts may be deficient with traditional TMJ exercise henceforth this aforementioned technique is traditionally indicated for treatment

The Shaker exercise is a series of sustained and repetitive head lifting exercises to enhance the strength of infrahyoid and suprahyoid muscular activity This exercise used to improve swallowing difficulties

Research Question Will there be any significant effect of Rocabado exercise and Shaker exercise in pain ROM QOL of patients with oral cancer

Aim and Objectives of the study

Aim To determine effect of Rocabado exercises and Shaker exercise in patients with oral cancer in order to regain functions and improve their overall quality of life

Objectives To find out effect of Rocabado exercises and Shaker exercise in patients with oral cancer on ROM To find out effect of Rocabado exercises and Shaker exercise on patients with oral cancer on pain To find out effect of Rocabado exercises and Shaker exercise on patients with oral cancer on QOL

Hypotheses

Null Hypothesis H0 There will be no discernible change in Pain ROM and QOL among patients with Oral cancer

Alternative Hypothesis There will be discernible change in Pain ROM and QOL among patients with Oral cancer

MATERIAL AND METHODOLOGY

Source of Data Oncology ward Dr Vithalrao Vikhe Patil Rural Hospital Loni Bk

Method of collection of data

Type of Data Quantitative

Study Design Randomised Controlled Trial

Study Setting Dr APJ Abdul Kalam College Of Physiotherapy Loni Bk

Sample size 70

Participants Patients with oral cancer

Sampling Method Simple random method

Material to be used

Consent form Case Record sheet Ruler Goniometer

SELECTION CRITERIA

Inclusion criteria Participants included will be Age group between 18 to 70 years both males and females Individuals undergone with postoperative oral cancer surgery

Exclusion criteria Participants excluded will be Individuals with any history of recent fracture nasal bone fracture maxillary or mandible Neurological or neuromuscular disease metabolic myopathies or myasthenia gravis Individuals not willing to participate

A Cervical and TMJ Range of Motion Assessment
TMJ assessment includes mouth opening protrusion and lateral excursion. Cervical assessment includes flexion extension lateral flexion and rotation.

B Postoperative Oral Dysfunction Scale 10
PODS 10 is a self reported tool to assess oral dysfunction in oral cancer patients after surgery. It contains 10 items with scores from 0 to 30. Higher scores indicate greater dysfunction.

C MD Anderson Dysphagia Inventory
MDADI is a dysphagia specific quality of life questionnaire for head and neck cancer patients. It includes 20 items and scores range from 0 to 100. Higher scores indicate better swallowing function.

D Visual Analogue Scale
VAS measures pain intensity using a 10 cm line. Scores range from 0 to 100. Higher scores indicate greater pain.

E Oral Health Quality of Life
OHQoL assesses the impact of oral health on physical psychological and social well being.

Procedure

All the subjects will be explained about the study and written inform consent form will be signed by each one of them Then Ethical approval from IEC Selection of Patients according to Inclusion and Exclusion criteria Pre task analysis assessment According to Outcome measures Intervention will be given Post Intervention assessment Results will be calculated

Rocabado Exercises Exercise is given in the patients with posttraumatic TMJ problems or with recent onset dysfunction that is largely posture related will generally progress quickly Once existing mechanical dysfunctions are corrected emphasis of treatment can be education on maintenance of good posture and oral habits

Exercise Techniques

Rocabado Exercise Program Rocabado advocates the instruction of six fundamental components of activity for treatment of TMJ dysfunction It is recommended that patients complete each activity 6 times per session and 6 times per day

The Shaker exercise Shaker exercise is a neck exercise that strengthens the suprahyoid muscles to improve swallowing The Shaker exercise is a series of sustained and repetitive head lifting exercises to enhance the strength of infrahyoid and suprahyoid muscular activity Shaker exercise includes isometric and isotonic exercises Isometric exercises are performed by raising the head up for 60 seconds followed by a minute rest for a repetition of three times

Intervention will be given for 6 weeks Statistical analysis will be done and results will be calculated

 
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