Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
NCT ID: NCT03545100
Last Updated: 2020-07-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-06-01
Study Completion Date
2020-02-06
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.
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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).
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).
Conditions
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Oral Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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experimental group
motor control therapy
Group Type
EXPERIMENTAL
motor control therapy
Intervention Type
OTHER
scapular muscle progressive resistive exercise(PRE)
regular physical therapy
Intervention Type
OTHER
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
control group
regular physical therapy
Group Type
ACTIVE_COMPARATOR
regular physical therapy
Intervention Type
OTHER
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
Interventions
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motor control therapy
scapular muscle progressive resistive exercise(PRE)
Intervention Type
OTHER
regular physical therapy
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
Intervention Type
OTHER
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
* 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
* 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
Minimum Eligible Age
20 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Yueh-Hsia Chen, Master
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
Taoyuan District, , Taiwan
Site Status
Countries
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Taiwan
References
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Chen YH, Huang CY, Liang WA, Lin CR, Chao YH. Effects of Conscious Control of Scapular Orientation in Oral Cancer Survivors With Scapular Dyskinesis: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211040827. doi: 10.1177/15347354211040827.
Reference Type
DERIVED
Other Identifiers
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201800026A3
Identifier Type: -
Identifier Source: org_study_id
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