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临床试验/NCT04566081
NCT04566081已完成不适用

Digital Interventions in Neuro-Rehabilitation (DINR): A Digital Neuro Intervention (DNI) for Word Retrieval (Anomia)

University College, London1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items

研究概览

简要总结

iTALKBetter will provide an app-based therapy for people with word retrieval difficulties who have had a stroke.

This study aims to test the therapy application for people with naming difficulties through a small scale item-randomized controlled trial.

详细描述

Mortality from stroke in the UK has reduced from 21% in 1999 to 12% in 2008. However, stroke prevalence has been increasing, the consequence of socioeconomic and scientific advances that have improved survival; which means that more people are surviving with long-standing disability. Language impairment (aphasia) is the second most common major impairment after stroke, with a prevalence of 250,000 in the UK. Aphasia may respond to therapy many months and years after the stroke occurs, but provision of specialist therapy (speech and language therapy - SALT) is far below that needed to provide optimal rehabilitation.

The investigators will address this by targeting a common symptom of post-stroke aphasia: impaired word retrieval problems. This is particularly important in patients receiving rehabilitation for associated disabilities as poor speech production can impair participation/compliance with treatment programmes. The study is designed to improve word retrieval in patients with post-stroke aphasia, who are in the chronic phase (>6 months post-stroke).

The main aim is to test the clinical efficacy of a novel, web-based, DNI. iTALKbetter will provide an effective training tool that patients can use to practice independently. This will free-up SALT time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.

iTALKbetter will provide an app-based therapy for people with word retrieval difficulties who have had a stroke (naming app for a wide variety of common words and phrases).

This Digital Neuro Intervention (DNI) will provide the opportunity for the necessary increased rehabilitation to help people recover lost naming function. This will alleviate NHS Speech and Language Therapist (SALT) time and put users in control of when and where they carry out practice-based language therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Any type of stroke but at least 6 months after onset.
  • Evidence of aphasia on the Comprehensive Aphasia Test
  • English as their dominant language
  • Able to tolerate MRI brain scan
  • Able to give informed consent
  • Able to use the DNI (app)

排除标准

  • No diagnosis of developmental language disorders
  • No diagnosis of severe dementia or primary progressive aphasia
  • No major co-existing neurological or psychiatric diagnosis
  • No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy).

研究组 & 干预措施

iTALKbetter

Experimental

There is only one arm (iTalkBetter), but within this arm there are two conditions, trained and untrained items. These are the therapy items (words). Half are trained and half are untrained. Each participant gets a different mix of trained or untrained items.

Participants received iTALKbetter therapy for 6 weeks. Participants are required to use the therapy for 1.5 hours everyday to reach the required dose of 60 hours over the 6 week period.

干预措施: iTalkBetter Trained Items (Behavioral)

iTALKbetter

Experimental

There is only one arm (iTalkBetter), but within this arm there are two conditions, trained and untrained items. These are the therapy items (words). Half are trained and half are untrained. Each participant gets a different mix of trained or untrained items.

Participants received iTALKbetter therapy for 6 weeks. Participants are required to use the therapy for 1.5 hours everyday to reach the required dose of 60 hours over the 6 week period.

干预措施: iTalkBetter Untrained Items (Behavioral)

结局指标

主要结局

Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items

时间窗: Two time points: 1. Pre- intervention (T3 = 6 weeks post baseline) 2. Post-intervention (T4 = 12 weeks post baseline)

The WRT is custom test of word retrieval comprised of a subset of the trained and untrained items form the iTALKbetter therapy. Participants accuracy on the word retrieval test is measured at two timepoints: pre intervention (T3), and post intervention (T4). There are 110 trained and 110 untrained items. Accuracy is reported as a percentage score (min = 0%, max = 100%) for each of the four conditions. The outcome is the percentage change in performance on the WRT. To investigate the efficacy of iTalkBetter in improving the retrieval of trained single words on the WRT, a repeated measures ANOVA was used which compared change in accuracy over the pre-therapy block and the therapy block. There were two factors, each with two levels: time (pre-therapy (Baseline to T3) and therapy (T3 to T4)); and item (trained and untrained lexical items).

次要结局

  • Qualitative Interviews(Baseline and Post-intervention (T4 = 12 weeks post Baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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