Biofeedback Rehabilitation to Improve Speaking and Eating in Public

Titre officiel

Rehabilitation of Head and Neck Cancer Patients With Biofeedback Training to Improve Speaking and Eating in Public

Sommaire:

Le cancer de la langue nécessite une résection et une reconstruction qui peuvent invalider les patients quant à leur capacité à parler et à manger. L’altération de la fonction de la langue peut entraîner des répercussions importantes sur les interactions sociales et l’emploi. Dans ce contexte, afin d’améliorer la capacité de parler et de manger en public, l’équipe du University Health Network évaluera l’utilisation d’un dispositif spécial conçu pour favoriser la réhabilitation des patients suivant le traitement de leur cancer de la langue. 

La partie de recherche de cette étude consistera à utiliser un embout (ou moule) buccal spécial, ressemblant un peu à la plaque supérieure de prothèses dentaires, qui sera appliqué au niveau du palais. Ce moule comprend 62 capteurs qui permettront aux patients de visualiser la position de leur langue quand ils parlent. Avec l’aide d’un orthophoniste, les patients peuvent apprendre les différentes positions importantes de la langue pour parler et manger. L’ensemble de ce processus s’appelle « rétroaction biologique ». La visualisation de la langue permet au patient de s’entraîner à la maison et d’apprendre les différentes positions de la langue importantes pour manger et parler. En outre, le dispositif fournira à l’orthophoniste l’occasion d’évaluer plus facilement et plus précisément les progrès des patients, ce qui peut réduire la nécessité des visites à l’hôpital. Les chercheurs s’attendent à ce que la formation par rétroaction biologique améliorera la capacité des patients à parler et à manger. 

L’hypothèse de l’étude est que le dispositif de rétroaction biologique améliorera les scores d’intelligibilité de la parole, des habiletés à manger et à parler en public, et d’ingestion des aliments par la bouche.

Description de l'essai

Primary Outcome:

• 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
• Change in Speech and Swallowing Over 4 Months

Secondary Outcome:

• Change in Patient Satisfaction of EPG Biofeedback Over 4 Months
• Difference in Cost for Intervention versus Standard of Care Over Time

Subjects will be enrolled in either arm of the study for duration of 4 months. Patients that are randomized into study arm 1 will come to the clinic for Speech Language Pathologist (SLP) directed face-to-face rehabilitation for a period of 2 months. The patients will then transition to participate in weekly face-to-face Electropalatography (EPG) biofeedback training. The EPG biofeedback will be used for 2 months. Patients that are randomized into study arm 2 will first undergo a self-directed tongue strengthening program (oral exercises) for a period of 2 months and then transition into EPG biofeedback training. Although randomization will be used, this is a nonstandard trial because all patients will receive biofeedback EPG. Patients from both study arms will receive biofeedback training after undergoing an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program (oral exercises). The SLP directed face-to-face rehabilitation program or self-directed tongue strengthening program will be initiated at least 2 weeks post-surgery. If the patient is treated with adjuvant radiation, the patient will take a self-directed biofeedback holiday with a target of restarting at least 2 after the completion of adjuvant treatment. This design was chosen because there is equipoise with respect to the efficacy of the intervention and uncertainty with respect to whether the intervention is most valuable following an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program. The design offers all patients the opportunity to participate in the intervention. This approach will also allow us to analyze between subject change and within subject change. The A.I.D.S assessment has been in place for approximately 50 years. The mean A.I.D.S. efficiency score (95%CI) in the current pilot study (n=16) is 0.54 (46.0, 62.3). With 33 patients in each group, there will be over 80% power to detect a 10% difference in the speech efficiency score even under the condition that there may be low (rho<0.1) correlation within subject. Higher correlation within subject on the various scores would serve to increase the efficiency of the analysis. Bivariate comparison will be made between the arms with respect to the primary and secondary outcome variables at each time point. Linear mixed model will be used to account for multiple measures at multiple time points. The first step will be to compare arms with respect to the primary and secondary outcome variables. For those tests that are significant a backward selected regression will be performed to control for confounders and to look for important effect modifier variables. Variables related to rehabilitation participation will be modeled in the backward selected regression.

Voir cet essai sur ClinicalTrials.gov