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CTRI Number  CTRI/2026/02/102995 [Registered on: 04/02/2026] 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   Rocabado approach and Shaker exercise effects on functionality and QOL in patients with Oral Cancer 
Scientific Title of Study   Randomized Controlled Trial for Comparative Effectiveness of the Rocabado Approach and Shaker Exercise on Functionality and Quality of Life in Oral Cancer Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Dr Deepali hande   ClinicalTrials.gov 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanushree Patil 
Designation  Postgraduate student 
Affiliation  Dr Deepali hande  
Address  Community physiotherapy Department 404 ,Dr APJ AK College of physiotherpy,Pravara institute of medical science,loni Bk
Community physiotherapy Department 404 ,Dr APJ AK College of physiotherpy,Pravara institute of medical science,loni Bk
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09834908838  
Fax    
Email  tanup1824@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tanushree Patil 
Designation  Postgraduate student 
Affiliation  Dr Deepali hande  
Address  Community physiotherapy department, Dr APJ AK College of physiotherpy,loni Bk
Community physiotherapy department,Dr APJ AK College of physiotherpy,Pravara institute of medical sciences, loni Bk
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09834908838  
Fax    
Email  tanup1824@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tanushree Patil 
Designation  Postgraduate student 
Affiliation  Dr Deepali hande  
Address  Dr APJ AK College of physiotherpy,loni Bk
Dr APJ AK College of physiotherpy,loni Bk
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09834908838  
Fax    
Email  tanup1824@gmail.com  
 
Source of Monetary or Material Support  
Dr APJ AK College of physiotherapy,Pravara Medical trust loni bk 
 
Primary Sponsor  
Name  Dr Tanushree Patil 
Address  Community Physiotherapy department Dr APJ AK College of physiotherapy,Pravara Medical trust loni bk 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
community department Dr Apj ak college of physiotherapy  Dr APJ AK College of physiotherapy Pravara Medical trust loni bk,ahmadnagar 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanushree Patil PT  Oncology ward 11 Dr Vithalrao vikhe patil Pravara rural hospital  Community physiotherapy department 404 , Dr APJ AK College of physiotherpy Pravara institute of medical science,loni ahmadnagar0
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: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1Rocabado s exercise 2 shakers exercise along with conventional physiotherapy exercise  Rocabado exercises are used for patients with post traumatic or posture related TMJ dysfunction These patients usually progress quickly After correction of mechanical dysfunction the focus shifts to education on posture and oral habits Rocabado six by six program includes six activities performed six times per session and six times per day The activities include tongue clucking to place the tongue on the hard palate and promote correct jaw rest position Controlled TMJ rotation where the tongue remains on the palate during opening to prevent excessive mandibular movement Mandibular rhythmic stabilization using gentle resistance to improve jaw control Upper cervical distraction to reduce neurovascular compression Axial cervical extension to correct forward head posture Shoulder girdle retraction to improve upper quarter posture The Shaker exercise is a head lift exercise used to strengthen suprahyoid muscles and improve swallowing in oral cancer patients It includes isometric head holding for sixty seconds repeated three times with rest followed by thirty rapid head lifts This exercise improves laryngeal elevation and opening of the upper esophageal sphincter It does not involve swallowing The six week rehabilitation program progresses through three phases Weeks one to two focus on swallowing exercises tongue range of motion oral motor jaw mobility and cervical and shoulder range of motion Weeks three to four emphasize strengthening coordination jaw exercises and oral sensory training Weeks five to six focus on functional swallowing trismus stretching and postural and shoulder strengthening 
Comparator Agent  conventional physiotherapy exercise  Week 1–2: Acute / Protective Phase 1. Swallowing Exercises 2. Tongue Range of Motion 3. Oral Motor Exercises 4. Jaw Mobility Exercises 5. Cervical & Shoulder ROM Week 3–4: Strengthening & Coordination Phase 1. Swallowing Strengthening 2. Jaw Exercises 3. Oral Somatosensory Training Week 5–6: Functional & Advanced Phase 1. Functional Swallowing Exercises 2. Trismus Stretching 3. Postural & Shoulder Strengthening 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  Age group between 18 – 70 years,
both males and females,
patients treated surgically along with adjuvant therapy Radiation Therapy and Chemotherapy
,patients treated non-surgically
 
 
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.
Inability to engage in oral exercises due to poor recovery of postoperative wounds
Individuals undergone Partial glossectomy , Hemiglossectomy etc

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cervical and TMJ Range Of Motion Assesment  0week 6week 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  0week 6 week 
Oral Health Quality of Life  0week 6week 
Postoperative Oral Dysfunction Scale-10   0week 6 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)   15/02/2026 
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="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  

Oral cancer is a major health problem in India largely due to the widespread use of tobacco and related products. Treatment of oral cancer commonly involves surgery with or without radiotherapy and chemotherapy which often leads to postoperative complications such as pain trismus restricted mouth opening dysphagia speech difficulties and postural dysfunction. These impairments significantly affect oral function daily activities and overall quality of life of patients.

Trismus is one of the most common and disabling complications following oral cancer treatment and occurs due to muscle fibrosis joint stiffness nerve involvement and scarring of soft tissues. Reduced jaw mobility interferes with eating speaking oral hygiene and social interaction thereby increasing physical and psychological distress. Early and structured physiotherapy intervention is essential to prevent long term functional limitations and to improve recovery.

Therefore this randomized controlled trial aims to evaluate and compare the effects of the Rocabado approach and Shaker exercise on pain range of motion and quality of life in patients with oral cancer to support evidence based rehabilitation strategies.

The outcome measures of the study include assessment of cervical spine and temporomandibular joint range of motion including mouth opening mandibular protrusion lateral mandibular movement overbite cervical flexion extension lateral flexion and rotation. Oral dysfunction will be evaluated using the Postoperative Oral Dysfunction Scale ten which is a reliable tool to assess functional limitations in patients with oral cancer following treatment. Pain intensity will be measured using the Visual Analogue Scale which is widely used to assess subjective pain severity. Quality of life related to oral health will be assessed using the Oral Health Quality of Life scale which evaluates physical psychological and social well being affected by oral health conditions.

All participants will be informed about the study and written informed consent will be obtained. Ethical approval will be secured prior to commencement. Patients will be selected based on inclusion and exclusion criteria and baseline assessment will be carried out using the selected outcome measures. Following this participants will receive the assigned intervention either Rocabado exercises or Shaker exercise. Post intervention assessment will be performed and results will be analyzed to determine the effectiveness of the interventions.

The Rocabado exercise program is designed to address temporomandibular joint dysfunction through postural correction and coordinated head neck jaw movements and is commonly used in posture related TMJ conditions. The Shaker exercise is a neck strengthening exercise that enhances suprahyoid muscle activity and is effective in improving swallowing jaw mobility and reducing trismus in patients with oral cancer after surgery or radiotherapy

 
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