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临床试验/CTRI/2025/09/094782
CTRI/2025/09/094782尚未招募1 期

A Randomized Controlled Trial to evaluate effectiveness of Rocabado approach and Shaker exercise on functionality and QOL in patients with Oral Cancer

Dr APJ AK College of physiotherapy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Cervical and tmj range of motion assessment

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Individuals undergone with post-operative oral cancer surgery.

排除标准

  • 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.

结局指标

主要结局

Cervical and tmj range of motion assessment

时间窗: Baseline measurements,and the of end treatment of 6week

次要结局

  • 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)

研究者

发起方
Dr APJ AK College of physiotherapy
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Tanushree patil

Dr APJ AK College of physiotherapy Loni ahmadnagar

研究点 (1)

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