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Behavioural Intervention

Electropalatography Biofeedback Training for Oral Squamous Cell Carcinoma (Biofeedback Trial)

N/A
Waitlist Available
Led By Douglas Chepeha, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at 0, 2, and 4 months
Awards & highlights

Biofeedback Trial Summary

This trial is testing a device that is designed to help tongue cancer patients rehabilitate their ability to speak and eat after treatment. The device uses sensors to help patients visualize their tongue position and learn different tongue positions for speaking and eating. The investigators expect that the biofeedback device will improve speech intelligibility, eating in public, speaking in public, and oral intake scores.

Eligible Conditions
  • Oral Squamous Cell Carcinoma

Biofeedback Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at 0, 2, and 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at 0, 2, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Percent Intelligibility of Speech Over 4 Months
Change in Rate of Intelligible Speech Over 4 Months
Change in Speech Acceptability Over 4 Months
+1 more
Secondary outcome measures
Change in Patient Satisfaction of EPG Biofeedback Over 4 Months
Difference in Cost for Intervention versus Standard of Care Over Time
Other outcome measures
Clinical Speech and Language Assessment
Fiberoptic Endoscopic Evaluation of Swallow (FEES)
Measure of Obliteration using Oral Volume Assessment Tool (OVAT)
+2 more

Biofeedback Trial Design

2Treatment groups
Experimental Treatment
Group I: Self-Directed Tongue Strengthening RehabExperimental Treatment1 Intervention
8 sessions of self-directed tongue strengthening exercises followed by 8 sessions of electropalatography biofeedback training. Assessments will be taken during the beginning, middle, and end of each study arm.
Group II: SLP Directed Face-to-Face RehabExperimental Treatment1 Intervention
8 sessions of SLP-directed face-to-face rehabilitation program followed by 8 sessions of electropalatography biofeedback training. Assessments will be taken during the beginning, middle, and end of each study arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electropalatography Biofeedback Training
2018
N/A
~40

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,056 Total Patients Enrolled
Douglas Chepeha, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
1 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Biofeedback Rehabilitation to Improve Speaking and Eating in Public
2018. "Biofeedback Rehabilitation to Improve Speaking and Eating in Public". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03650699.
~5 spots leftby Apr 2025
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