MedDataX Logo

Trial Outcomes & Findings for Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC) (NCT NCT00815087)

NCT ID: NCT00815087

Last Updated: 2014-03-26

Results Overview

A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Averaged 2 months

Results posted on

2014-03-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Functional Electrical Stimulation (FES)
n=10 Participants
Functional electrical stimulation: Experimental Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session
Home Rehabilitation Program (HRP)
n=10 Participants
Exercise home program Exercise home program : Daily exercise training
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
52.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
56.1 years
STANDARD_DEVIATION 11.8 • n=7 Participants
54.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Region of Enrollment
Taiwan
10 participants
n=5 Participants
10 participants
n=7 Participants
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: Averaged 2 months

A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.

Outcome measures

Outcome measures
Measure
Functional Electrical Stimulation (FES)
n=10 Participants
Functional electrical stimulation: Experimental Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session
Home Rehabilitation Program (HRP)
n=10 Participants
Exercise home program Exercise home program : Daily exercise training
The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months
0.8 cm/s
Standard Deviation 0.5
-0.4 cm/s
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 1 to 3 months

Outcome measures

Outcome data not reported

Adverse Events

Functional Electrical Stimulation (FES)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Home Rehabilitation Program (HRP)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Wang TG

Wang tyng

Phone: +886-2-23123456

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place