Dysphagia, Late Effect of StrokeBIO_DYSNCT03247374
Bio-feedback Treatment for Dysphagic Post-stroke Patients
A study testing "ProComp5 Infiniti" Biofeedback and Standard Speech and Language Therapy in people with Dysphagia, Late Effect of Stroke and Deglutition Disorders, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Dysphagia, Late Effect of Stroke, Deglutition Disorders
- What is being tested?
- "ProComp5 Infiniti" Biofeedback and Standard Speech and Language Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2018to 4 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bio-feedback Treatment Versus Standard Treatment for Dysphagic Post-stroke Patients: a Randomized Controlled Trial
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.
Read the detailed description
The procedure is divided into 5 parts:
- Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions before the treatment;
- 25 sessions with bio feedback treatment or 25 sessions of control treatment;
- Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after the training;
- Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after 3 months.
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 that will take about 10 minutes for assembly and 5 minutes for removal. At the beginning of the bio-feedback session, a surface electrode will be applied to the mylohyoid muscle. The computer will analyze the electromyographic signal of the patient in real time and 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 favor swallowing strength and efficacy.
During the first session, participant will be instructed to use the tool before starting the training phase. Patients of both groups will participate in similar sessions, with classical maneuvers favoring swallowing efficacy that is 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 with the support of visualization of muscle activity on the screen (biofeedback), while the control group will attend the same training for 45 minutes, but receiving verbal feedback from the speech and language therapist.
Data analysis
On the measures collected, a descriptive statistical analysis and distribution will be studied. Initial instrumental and clinical data from FOIS scale (The Functional Oral Intake Scale), PAS (Penetration-Aspiration Scale), Pooling Score (Farneti et al.); Cranial nerves test will be analyzed using parametric (t-test) and non-parametric (Wilcoxon test) tests with a p-value considered significant if <0.05, while longitudinal variations will be analyzed using ANOVA for repeated measurements. In addition, the effect size (Cohen's d) of the difference between the instrumental and clinical evaluation scales average before and after training in both groups will be calculated. This will allow to have an estimate of training effectiveness to perform a power study and plan a wider experimental study for validating the method.
- Being tested
- "ProComp5 Infiniti" Biofeedback, Standard Speech and Language Therapy
- Keywords
- rehabilitation, treatment, biofeedback, bio-feedback, dysphagia, swallowing disorders, post-stroke, deglutition disorders
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"ProComp5 Infiniti" BiofeedbackDevice
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.
Standard Speech and Language TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Other: Standard Speech and Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Oral Intake Scale (FOIS)
It is a 7-point scale developed to systematically rate the functional severity of dysphagia
Measured: Baseline , 4 weeks , finally after 3 months from the end of treatment
Secondary outcomes (2)
Change in Pooling Score (P-score)
The scale is used during clinical endoscopic evaluation to evaluate severity of swallowing disorder, considering excess residue in the pharynx and larynx.The score (minimum 4 - maximum 11) is obtained by the sum of the scores given to the site of the bolus, the amount and ability to control residue/bolus pooling, the latter assessed on the basis of cough, raclage, number of dry voluntary or reflex swallowing acts.
Measured: Baseline , 4 weeks , finally after 3 months from the end of treatment
Change in Penetration-Aspiration Scale (PAS)
It is a 8-point scale used during endoscopic evaluation that describes and measures the severity of airway invasion during swallowing.
Measured: Baseline , 4 weeks , finally after 3 months from the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start27 Feb 2018
- Primary completion1 Oct 2020
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, Late Effect of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- simple randomization into two groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Nordio, IRCCS San Camillo, Venezia, Italy
- Investigators
- Sara Nordio, Principal investigator, IRCCS San Camillo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247374
- Sponsor's protocol ID
- 2017.12 - BioDis
- Acronym
- BIO_DYS
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2017
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-feedback Treatment Versus Standard Treatment for Dysphagic Post-stroke Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03247374
- Acronym / sponsor ID
- BIO_DYS / 2017.12 - BioDis
- Keywords
- rehabilitation, treatment, biofeedback, bio-feedback, dysphagia, swallowing disorders, post-stroke, deglutition disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The procedure is divided into 5 parts:
- Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions before the treatment;
- 25 sessions with bio feedback treatment or 25 sessions of control treatment;
- Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after the training;
- Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after 3 months.
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 that will take about 10 minutes for assembly and 5 minutes for removal. At the beginning of the bio-feedback session, a surface electrode will be applied to the mylohyoid muscle. The computer will analyze the electromyographic signal of the patient in real time and 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 favor swallowing strength and efficacy.
During the first session, participant will be instructed to use the tool before starting the training phase. Patients of both groups will participate in similar sessions, with classical maneuvers favoring swallowing efficacy that is 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 with the support of visualization of muscle activity on the screen (biofeedback), while the control group will attend the same training for 45 minutes, but receiving verbal feedback from the speech and language therapist.
Data analysis
On the measures collected, a descriptive statistical analysis and distribution will be studied. Initial instrumental and clinical data from FOIS scale (The Functional Oral Intake Scale), PAS (Penetration-Aspiration Scale), Pooling Score (Farneti et al.); Cranial nerves test will be analyzed using parametric (t-test) and non-parametric (Wilcoxon test) tests with a p-value considered significant if <0.05, while longitudinal variations will be analyzed using ANOVA for repeated measurements. In addition, the effect size (Cohen's d) of the difference between the instrumental and clinical evaluation scales average before and after training in both groups will be calculated. This will allow to have an estimate of training effectiveness to perform a power study and plan a wider experimental study for validating the method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- simple randomization into two groups
| Arm | Type | Receives |
|---|---|---|
| "ProComp5 Infiniti" Biofeedback | Experimental | Device: "ProComp5 Infiniti" BiofeedbackEach 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. |
| Standard Speech and Language Therapy | Active comparator | Other: Standard Speech and Language TherapyEach 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. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "ProComp5 Infiniti" BiofeedbackEach 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. | Device | "ProComp5 Infiniti" Biofeedback |
| Standard Speech and Language TherapyEach 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. | Other | Standard Speech and Language Therapy |
Primary outcome
Change in Functional Oral Intake Scale (FOIS)
Time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
It is a 7-point scale developed to systematically rate the functional severity of dysphagia
2 secondary outcomes
Change in Pooling Score (P-score)
Time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
Change in Penetration-Aspiration Scale (PAS)
Time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
Related trials for Dysphagia, Late Effect of Stroke
Not yet recruiting
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
Stroke Sequelae, Deglutition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Nordio principal investigator
IRCCS San Camillo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "ProComp5 Infiniti" Biofeedback and Standard Speech and Language Therapy in people with Dysphagia, Late Effect of Stroke and Deglutition Disorders, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Oral Intake Scale (FOIS) (time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.