| 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
|
|
|
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 |