Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00815087
First received: December 25, 2008
Last updated: March 2, 2014
Last verified: March 2014
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dysphagia
Interventions: Device: Functional electrical stimulation
Behavioral: Exercise home program

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty subjects were referral from department of oncology & physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan. The study was approved by the Ethics Committee of the National Taiwan University Hospital. All participants gave their informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
They were assigned into the FES group and home rehabilitation program (HRP) group by the method of sex stratified randomization, and were matched by Dysphagia Outcome and Severity Scale (DOSS) score within 1 unit in order to compare two groups under the same sex proportion and similar DOSS score pairs.

Reporting Groups
  Description
Functional Electrical Stimulation (FES)

Functional electrical stimulation: Experimental

Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session

Home Rehabilitation Program (HRP)

Exercise home program

Exercise home program : Daily exercise training


Participant Flow:   Overall Study
    Functional Electrical Stimulation (FES)     Home Rehabilitation Program (HRP)  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
We decided to make the cut point when the numbers of 2 groups are equal.

Reporting Groups
  Description
Functional Electrical Stimulation (FES)

Functional electrical stimulation: Experimental

Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session

Home Rehabilitation Program (HRP)

Exercise home program

Exercise home program : Daily exercise training

Total Total of all reporting groups

Baseline Measures
    Functional Electrical Stimulation (FES)     Home Rehabilitation Program (HRP)     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52.3  ± 7.4     56.1  ± 11.8     54.2  ± 10.3  
Gender  
[units: participants]
     
Female     4     4     8  
Male     6     6     12  
Region of Enrollment  
[units: participants]
     
Taiwan     10     10     20  



  Outcome Measures

1.  Primary:   The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months   [ Time Frame: Averaged 2 months ]

2.  Secondary:   Questionnaire of Life Quality   [ Time Frame: 1 to 3 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lack of information about muscle fibrosis, no control group. and the results from the small amount of subjects.  


Results Point of Contact:  
Name/Title: Dr.Wang TG
Organization: Wang tyng
phone: +886-2-23123456 ext 67587
e-mail: patty.jt@gmail.com


No publications provided


Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00815087     History of Changes
Other Study ID Numbers: 200804032R
Study First Received: December 25, 2008
Results First Received: November 13, 2013
Last Updated: March 2, 2014
Health Authority: Taiwan: Department of Health