Bio-feedback Treatment for Dysphagic Post-stroke Patients

NCT03247374 | Completed

• 1 other identifier: 2017.12 - BioDis
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the study is to evaluate whether the effect of bio-feedback dysphagia treatment is more effective than a control treatment in post-stroke patients. This study will be a randomized, single-blind controlled pilot study. The investigators intend to recruit 40 patients who have suffered a stroke and have dysphagia. Twenty patients will undergo training with bio-feedback (experimental group) and the other 20 patients will undergo standard training, using only verbal feedback rather than visual feedback (control group). The authors hypothesize that in the control group the efficacy of the treatment will be lower in the absence of immediate visual feedback of strength and coordination of the swallowing act.

Conditions

Dysphagia, Late Effect of Stroke; Deglutition Disorders

Keywords

rehabilitation; treatment; biofeedback; bio-feedback; dysphagia; swallowing disorders; post-stroke; deglutition disorders

Outcome Measures

Primary Outcomes (1)

• Change in Functional Oral Intake Scale (FOIS)

  It is a 7-point scale developed to systematically rate the functional severity of dysphagia

  Baseline , 4 weeks , finally after 3 months from the end of treatment

Secondary Outcomes (2)

• Change in Pooling Score (P-score)

  Baseline , 4 weeks , finally after 3 months from the end of treatment

• Change in Penetration-Aspiration Scale (PAS)

  Baseline , 4 weeks , finally after 3 months from the end of treatment

Study Arms (2)

"ProComp5 Infiniti" Biofeedback

EXPERIMENTAL

Each participant will attend 5 sessions per week for a total duration of 5 weeks. The duration of each session will take 1 hour, including bio-feedback preparation. At the beginning of the bio-feedback session, a surface electrode will be applied to the mylohyoid muscle. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: effortful swallow, supraglottic swallow, and "Masako" maneuver, the first two with bolus administration, if possible. The experimental group will perform this training for 45 minutes, plus they will receive a verbal feedback from the speech and language therapist.

Device: "ProComp5 Infiniti" Biofeedback

Standard Speech and Language Therapy

ACTIVE COMPARATOR

Each participant will attend 5 sessions per week for a total duration of 5 weeks. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: effortful swallow, supraglottic swallow, and "Masako" maneuver, the first two with bolus administration, if possible. The control group will attend this training for 45 minutes, receiving verbal feedback from the speech and language therapist.

Other: Standard Speech and Language Therapy

Interventions

"ProComp5 Infiniti" Biofeedback DEVICE

Each participant will attend 5 sessions per week for a total duration of 5 weeks. At the beginning of the bio-feedback session, a surface electrode will be applied to the mylohyoid muscle. The computer will produce visual feedback of the muscular activity on the screen. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: they are requested to do classical maneuvers that favour swallowing efficacy that is effortful swallow, supraglottic swallow, and "Masako" maneuver. The experimental group will perform this training for 45 minutes.

"ProComp5 Infiniti" Biofeedback

Standard Speech and Language Therapy OTHER

Each participant will attend 5 sessions per week for a total duration of 5 weeks. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy receiving verbal feedback from the speech and language therapist. They are requested to do classical maneuvers that favour swallowing efficacy that is effortful swallow, supraglottic swallow, and "Masako" maneuver. The control group will perform this training for 45 minutes.

Standard Speech and Language Therapy

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first stroke injury
• single lesion
• onset from more than six weeks
• presence of dysphagia (Dysphagia Outcome and Severity Scale ≥ 4)
• good comprehension ( not below PT 53 in Token Test)
• good eyesight and hearing, or adequately corrected

You may not qualify if:

• All the elements that hinder a good recording of the electromyographic signal (for instance a cutaneous infection, a wound or a dermatitis in the submandibular area);
• Severe concomitant illnesses (fever, infections, metabolic problems, serious cardiac insufficiency) that can influence patient's collaboration;
• Serious dystonia or unintentional movements
• presence of disorders of consciousness;
• encephalopathy due to multiple infarcts;
• inability to sustain the experimental treatment;
• other neurological diseases (for example Parkinson disease);

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

Sara Nordio

Venice-Lido, Italy

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Sara Nordio

  IRCCS San Camillo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech and language therapist

Model Details: simple randomization into two groups

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 11, 2017
• Study Start: February 27, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 4, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

IT (1)