Swallow Strength and Skill Training with Biofeedback in Acute Post Stroke Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Feasibility in patients with acute post stroke dysphagia
研究概览
简要总结
About 50% of people who have a stroke experience difficulty swallowing. There is a growing evidence base showing that swallowing therapy can help to improve swallowing, but we don't know which type or how much therapy is most beneficial. The investigators are further developing one particular intervention - swallow strength and skill training with biofeedback. This involves practicing strong or effortful swallows and practicing controlling the timing of swallowing using visual feedback on a screen showing the activity of the muscles involved in swallowing. The investigators want to know whether trained clinicians are able to deliver this therapy in acute hospital settings early after stroke. The investigators also want to explore whether there is an effect of dose in improving swallowing and other health factors. To do this the investigators will conduct a trial across several stroke units in the east midlands. The study aims to recruit 120 participants who have had a stroke and have dysphagia and who will randomly be placed in one of three groups. One group will get a standard dose therapy (10 x 35 minute sessions over 2 weeks), another group with receive a high dose therapy (20 x 35 minute sessions over 2 weeks) and the third will receive 'usual care' which is what they would usually get from their current service. The investigators will look at what therapy participants actually get, what factors might influence this and the training, support and conditions that enable clinicians to deliver the therapy. The investigators will also assess the participants swallowing and collect information on their health, face to face at the beginning and after the therapy and over the phone at three months.
详细描述
A PPI group of people or carers of people who have post stroke swallowing difficulties have been convened and consulted regarding the methodology. They have helped to decide which swallowing outcome measures should be collected at which time points. They have reviewed and fed back on the participant information sheets and are helping to decide on which format of visual biofeedback is best for the therapy sessions. A group pf stakeholder SLTs and SLTAs are helping to design the training and materials to be used to train up clinicians to deliver the intervention as part of this trial.
Recruitment The clinical trial will be carried out in the stroke units of three East Midlands services. The study aims to recruit 120 patients. Patients who have had a stroke will be screened for initial eligibility by clinical teams. Eligible patients will be given verbal and written information about the study. Extra time will be given to patients who have cognitive/communication difficulties to support their understanding of the research. Patients will be given up to 24 hours to talk to their families and decide whether they want to participate. If they indicate they want to participate the researcher will assess their capacity to consent and ask them to complete a consent form. If a patient does not have the capacity to consent advice will be sought from their next of kin about whether they think the patient might have wanted to be involved.
Eligibility screen Once consent is given, study participants will have a further eligibility screen by one of the clinical Speech and Language Therapists to see whether they have the visual, communication, cognitive and swallowing ability to be able to complete the intervention. Electrodes will be placed on the muscles underneath the participants' chin and connected to a laptop via an sEMG device, participants will be asked to swallow and track the signal their swallowing makes on the screen, if they can do this they will be eligible to participate. Information about the participants health, stroke and demographics will be collected to explore reasons why some patients are not able to complete the intervention to help with eligibility criteria in the future. No further data will be collected for those who fail the screen.
Baseline measures Measures of swallowing strength and skill will be recorded for participants who pass the eligibility screen, this involves producing a number of regular and strong (effortful) swallows. Further baseline measures will be collected by research nurses including their current swallow severity, stroke severity, quality of life etc.
Randomisation Once collected, key information about participants age, stroke & swallow severity as well as which site they are recruited from will be entered into an online secure research database which will randomly assign them to one of three treatment groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18
- •Clinical diagnosis of stroke
- •>1 week and < 8 weeks post stroke
- •New moderate to severe dysphagia (DSRS ≥4) with a score of at least 1 on the fluid sub-section
- •Not rapidly improving dysphagia (2 clinical SLT assessments over a week showing minimal change in DSRS)
- •Pass an eligibility screen - sufficient visual, cognitive and communication skills to participate in the intervention
排除标准
- •Medically unwell, GCS <10, on >4L oxygen, poor prognosis, EOLC
- •Previous dysphagia
- •Degenerative neurological condition
- •Severe visual impairment
- •Severe cognitive & communication impairment
- •Patient likely to be repatriated to or rehabilitated at another organisation with 10 days
- •Participation in another trial aimed at improving dysphagia
- •Unwilling to remove beard/hair from under chin
结局指标
主要结局
Feasibility in patients with acute post stroke dysphagia
时间窗: Throughout study completion, to be completed by December 2024
Number of participants recruited, dose of swallow therapy
Feasibility of delivery by acute stroke NHS clinicians - the intervetion
时间窗: Through study completion, to be completed by December 2024
Percentage of core components of the intervention delivered (fidelity checklist from observations)
Feasibility of delivery by acute stroke NHS clinicians - the training
时间窗: Through study completion, to be completed by December 2024
Usefulness of training and training materials (qualitative interviews)
次要结局
- Dysphagia Severity(Day 15)
- Swallow Strength and Skill(Day 15)
- Pnuemonia(Day 90)
- Feasibility of cost effectiveness methods(Day 90)
- Feeding Status(Day 15)