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Researcher needing time off
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| Name | Class |
|---|---|
| Irish Research Council | OTHER |
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This is a pilot randomised controlled trial investigating whether using modification of saccadic eye movements can control lateral unconscious tongue positioning and enhance fluency in adults with a confirmed developmental stammer. This study is being conducted as part of an MSc by research qualification at the Institute of Technology Sligo in Ireland with a view to extending to PhD. The setting is home setting with all assessments either taking place at home via video link or in the institute. The study is being conducted in conjunction with the Community Speech and Language Therapist and has attained ethical approval through Sligo University Hospital (SUH) Ethics Committee.
Participants will be assessed for stammering severity either on line via video link or in the Institute of Technology Sligo Health Science & Exercise Physiology Lab (B2004) at three time points: before intervention, after a five-week trial period and three months post completion. Participants will complete two assessments at each time to cater for "off" days. Participants will be required to practice quick eye movements at the start of words / syllables where dysfluencies are predicted for 10 minutes twice a day for the treatment period. Training in eye movement (saccade) modification will occur following the initial assessment in IT Sligo, or video link.
Participants will be assigned to one of two treatment arms. An experimental arm, and a control (placebo) arm. All participants will be assessed regarding their premonitory awareness of anticipated dysfluencies both before training and at the three month Based on advice from Community Speech and language Manager (Ms Sinead Carthy), participants will voice/video message the principle investigator once per week for this five-week period to confirm compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Looking down to naval. | Experimental | Modifying Saccade origin by looking down to naval. |
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| Looking up in the air. | Placebo Comparator | Modifying Saccade origin by looking up in the air. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modifying saccades by looking down to naval. | Behavioral | Paragraphs from list Provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly down to their naval to reset the lateral tongue position. |
| Measure | Description | Time Frame |
|---|---|---|
| Stammering Severity (SSI-4) (Howell et. al. 2011). | Measures stuttering severity in adults and children. It measures the percentage of stuttered syllables versus fluent speech in the participant. It also measures the frequency of repetition and prolongations, duration of blocks, and physical concomitants. | 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006). | Measures the impact of stuttering on a person's life. Scores range between 1 (Mild) and 5 (Severe). The impact is broken down to four sections: General Information, Speaker's reactions, Daily Communication and Quality of life. There is also an overall impact score. | 10 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary Mc Donagh, MSc | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Technology, Sligo | Sligo | Co Sligo | F91YW50 | Ireland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2020 | Apr 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2020 | Apr 17, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2020 | Apr 17, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013342 | Stuttering |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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Pilot Randomised Placebo Controlled Trial
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Experimental Group instructed to modify saccadic origin by looking to naval for the start of the words dysfluencies were predicted
Placebo Group instructed to modify saccadic origin by looking up for the start of the words dysfluencies were predicted
Outcome assessor was blinded to treatment allocation. Participants Stammering behaviour to be assessed using SSI-4 a reliable validated objective measure of stuttering severity. Participants stammering behaviour is to be recorded via video link or in a separate lab and the assessor will be asked asked not to discuss the technique prescribed given to patients. Even if the patient mentioned the trials they would not discuss the intervention
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| Modifying saccades by looking in air. | Behavioral | Paragraphs from list provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly up to reset the lateral tongue position. |
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| Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016). | Measures the anticipation effect in stuttering. 14 items assessing premonitory awareness of stuttering sensation to assess the individual's capacity, manner and style of anticipation. Each item consists of a 4-point Likert scale ranging from "not at all" to "very much". A higher score indicates a larger anticipation of stuttering by the participant. | 10 minutes. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |