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Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Primary Purpose

Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
motor control therapy
regular physical therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer focused on measuring oral cancer, shoulder dysfunction, quality of life, motor control, strengthening exercise

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

motor control therapy

regular physical therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2018
Last Updated
July 14, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03545100
Brief Title
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Official Title
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
February 6, 2020 (Actual)
Study Completion Date
February 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
oral cancer, shoulder dysfunction, quality of life, motor control, strengthening exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
motor control therapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
regular physical therapy
Intervention Type
Other
Intervention Name(s)
motor control therapy
Intervention Description
scapular muscle progressive resistive exercise(PRE)
Intervention Type
Other
Intervention Name(s)
regular physical therapy
Intervention Description
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
Primary Outcome Measure Information:
Title
shoulder pain
Description
Visual Analog Scale, the *total* range = 0-10
Time Frame
1 year
Title
shoulder joint range of motion
Description
abduction measured by goniometer
Time Frame
1 year
Title
shoulder function
Description
the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
Time Frame
1 year
Title
maximal isometric muscle strength
Description
measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG
Time Frame
1 year
Secondary Outcome Measure Information:
Title
surface electromyography (SEMG)
Description
measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior
Time Frame
1 year
Title
quality of life C-30
Description
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
Time Frame
1 year
Title
quality of life H&N35
Description
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
Time Frame
1 year
Title
return to work
Description
duration between return-to-work and operation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh-Hsia Chen, Master
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

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