Biofeedback Rehabilitation to Improve Speaking and Eating in Public

NCT03650699 | Completed DMC

• 1 other identifier: 17-5105
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Tongue cancer requires resection and reconstruction that can leave patients disabled with respect to speaking and eating. Impairment of tongue function can have significant impact on social interaction and employment. To try and improve speaking and eating in public, the team at the University Health Network is going to use a special device that is designed to help the patient rehabilitate after tongue cancer treatment. The research part of this study is to use a special mouthpiece or mold that is like a partial plate for upper dentures that will fit on the roof of the mouth. This mold is embedded with 62 sensors that will allow patients to visualize their tongue position during speech. With the help of a speech therapist, patients can learn different tongue positions important speaking and eating. This whole process is called biofeedback. The visualization of the tongue gives the patient the flexibility to practice at home to and learn different tongue positions important to eating and speaking. In addition, the device will provide the speech pathologist with an opportunity for easier and more precise assessment of the patient's progress which can reduce the need for visits to the hospital. The investigators expect the biofeedback training to improve the patient's speaking and eating. The study hypothesis is that the biofeedback device will improve speech intelligibility, eating in public, speaking in public, and oral intake scores.

Conditions

Oral Cavity Squamous Cell Carcinoma

Keywords

Oral Cavity Squamous Cell Carcinoma; Biofeedback; Rehabilitation; Head and Neck Cancer; electropalatography; EPG

Outcome Measures

Primary Outcomes (4)

• Change in Percent Intelligibility of Speech Over 4 Months

  Change in percent intelligibility is measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure intelligibility as compared with normal subjects for quantifying single-word intelligibility and sentence intelligibility.

  Administered at 0, 2, and 4 months

• Change in Rate of Intelligible Speech Over 4 Months

  Change in intelligibility rate is also measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure speed of language as compared with normal subjects for quantifying speaking rate.

  Administered at 0, 2, and 4 months

• Change in Speech Acceptability Over 4 Months

  Assessment of Speech Acceptability is a qualitative measure of "conversational understandability" of language as compared with normal subjects. Subjects will be given 6-word sentences to read where five naïve listeners will evaluate the speakers' speech acceptability on a scale of 4. This is a subsection of the AIDS test.

  Administered at 0, 2, and 4 months

• Change in Speech and Swallowing Over 4 Months

  This is a disease specific, 6-item, administered questionnaire to evaluate post-treatment speech and swallowing ability measure will provide critical data on the socialization of the patient as it relates to speaking and eating.

  Administered at 0, 2, and 4 months

Secondary Outcomes (2)

• Change in Patient Satisfaction of EPG Biofeedback Over 4 Months

  Administered time 0, 2, and 4 months

• Difference in Cost for Intervention versus Standard of Care Over Time

  Weekly, Up to 16 Weeks

Other Outcomes (5)

• Measure of Obliteration using Oral Volume Assessment Tool (OVAT)

  Administered at 0, 2, and 4 months

• Measure of Tongue Protrusion

  Administered at 0, 2, and 4 months

• Measure of Tongue Elevation

  Administered at 0, 2, and 4 months

Study Arms (2)

Self-Directed Tongue Strengthening Rehab

EXPERIMENTAL

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.

Device: Electropalatography Biofeedback Training

SLP Directed Face-to-Face Rehab

EXPERIMENTAL

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.

Device: Electropalatography Biofeedback Training

Interventions

Electropalatography Biofeedback Training DEVICE

The study agent is electropalatography (EPG). The LinguaGraph EPG device is a biofeedback technology that creates a digital visualization of tongue function during speech. The visualization is accomplished by a custom made mouthpiece that fits over the hard palate with 62 sensors that capture tongue position. The information from the sensors in the mouthpiece, as well as the audio output, is processed in an EPG Unit that converts the information from mouthpiece to a visual representation on a computer screen. The visual information with respect to tongue position can be used to provide biofeedback training.The computer can be used in the clinic during a patient visit or it can be seen over the internet with the patient at home and the speech and language pathologist at the clinic.

SLP Directed Face-to-Face Rehab; Self-Directed Tongue Strengthening Rehab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Oral cavity carcinoma involving the tongue or floor of the mouth
• Primary surgical treatment or/
• Primary surgical treatment with adjuvant radiation therapy or/
• Salvage surgical treatment
• At least 2 weeks post treatment

You may not qualify if:

• Anatomic palate abnormality that precludes fitting a mouthpiece
• Cognitively unable to participate in biofeedback
• Persistent Cancer
• Does not speak English

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Douglas Chepeha, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: August 29, 2018
• Study Start: September 28, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CA (1)