Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Study Overview
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Brief Summary
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Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.

Detailed Description
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Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied. The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from April 2018 to March 2020. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). Experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).

Official Title
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Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Conditions
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Oral Cancer

Intervention / Treatment
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* Other: motor control therapy
* Other: regular physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign the inform consent Sufficiently communicate in the Chinese language Be able to follow instructions Newly diagnosed oral cancer Spinal accessory shoulder dysfunction Exclusion Criteria: Pregnant or breast-feeding woman Cognitively impaired Central nervous disease Distant metastasis or recurrence A history of shoulder pain or known shoulder pathology Unable to communicate or comprehend the questionnaires

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>motor control therapy | Other: motor control therapy<br>* scapular muscle progressive resistive exercise(PRE)<br>Other: regular physical therapy<br>* transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE<br>|
| Active Comparator: control group<br>regular physical therapy | Other: regular physical therapy<br>* transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder pain | Visual Analog Scale, the *total* range = 0-10 | 1 year | 
| shoulder joint range of motion | abduction measured by goniometer | 1 year | 
| shoulder function | the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function | 1 year | 
| maximal isometric muscle strength | measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surface electromyography (SEMG) | measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior | 1 year | 
| quality of life C-30 | European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 | 1 year | 
| quality of life H&N35 | European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35 | 1 year | 
| return to work | duration between return-to-work and operation | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral cancer, shoulder dysfunction, quality of life, motor control, strengthening exercise