Modifying Unconscious Tongue Movements to Improve Fluency in Adults With a Confirmed Developmental Stammer. A Pilot Randomised Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Stammering Severity (SSI-4) (Howell et. al. 2011).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults age > 18 years.
- •A diagnosis of confirmed developmental stammer from SALT characterized by stammering on ≥ 3% of syllables.
- •A proficiency in the English Language.
- •No diagnosis of any emotional, behavioural, learning or neurological disorder.
- •Cognitive ability to take part.
- •Have previously completed a course of outpatient treatment for confirmed developmental stammer.
排除标准
- •Younger than 18 years.
- •Not having completed a traditional intervention for stammer.
- •This research is not intended to replace current interventions but provide additional possibilities for those adults who have completed a standard programme of intervention and their developmental stammer still persists and a rate of ≥ 3% of syllables
结局指标
主要结局
Stammering Severity (SSI-4) (Howell et. al. 2011).
时间窗: 10 minutes.
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.
次要结局
- Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016).(10 minutes.)
- Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006).(10 minutes.)