None listed
Conditions
Brief summary
This pilot, crossover trial will recruit 12 participants aged 10-25 years with dysarthria. Participants will compete 4 weeks of speech therapy using a voice-assistant device, according to a therapy plan provided by the research team. The aim of this study is to describe the parent/caregiver and patient experience of the tolerability, safety and utility of a four-week period of voice assistant-based speech therapy, using the 'Alexa' system. Pre/post changes in speech intelligibility, and perceptual and acoustic speech quality will also be explored.
Interventions
The therapy approach being trialed is a four-week period of semi-structured, guided use of a voice assistant (specifically Amazon’s ‘Alexa’) for speech therapy. We will recruit participants with the speech disorder dysarthria, from two subgroups: (i) Perisylvian PMG; (ii) FOXP1 syndrome. This is a cross over trial - all participants will complete 4 weeks of treatment or 4 weeks of control, then swap to the opposite condition. There will be 4 weeks of washout between each condition. Each subgroup will include 6 participants, who will be randomised equally to each of the two sequences (Sequence A treatment then control (n=3 PMG and 3 FOXP1); Sequence B control then treatment (n=3 PMG and 3 FOXP1)). This therapy will be completed by the participant in their home. Participants assigned to the intervention arm will be sent the following items: 1. A voice assistant device by courier. 2. An introductory email containing: a. A prerecorded video showing how to set up the device in the family’s home (e.g. how to connect it to the internet, where to place the device to reduce background noise). b. A therapy plan outlining the family’s timeline in the study, important dates (e.g. assessment dates) and the questions for the participant to ask Alexa during each speech practice session. An accompanying video of an example session will also be produced and sent to families. During the four-week period that the participant is assigned to the voice assistant treatment arm, they will be asked to complete at least 1 session a day. We anticipate that each session will take 10-15 minutes. Parents will facilitate each session as per the therapy plan provided (detailed above), according to the following general structure: 1. Repeated sentences (5): Parent tells (verbally) participant five sentences to ask Alexa. These sentences will be different each day, and prescribed by the research team in the PDF therapy plan. It will be up to the participant to include the wake word (“Alexa”). For example, the parent would ask “Tell me what the weather is today”; ? child: “Alexa, tell me what the weather is today.” 2. Participant generated sentences (5): Parent will prompt child to ask Alexa five additional sentences, which will be generated by the participant. For participants who cannot generate a novel question, parents will be given prompts in the PDF therapy plan to ask participant. For example: Parent “Can you ask Alexa about the football score?” ? child: “Alexa, what is the footy score?” Participants will be encouraged to use the device outside of the facilitated session per day, however additional use will not be prescribed. In this sense, the facilitated session is acting as the minimum dosage. Any additional usage will be additional dosage. Dosage will be tracked using written transcripts which are automatically recorded by Alexa. We will ask parents to send us these transcripts and audio recordings at the close of the four-week intervention period. Parents will be guided to do this during the telehealth assessment session at the close of the intervention period. These recordings will be saved by the study team. Parents will be asked not to interact with Alexa (on the device used for the trial), to ensure recordings and transcripts relate to the trial. Should parents or other members of the house use Alexa on the trial device accidentally, parents will be given an opportunity to delete these incidental recordings, prior to sending these to the study team. Parents will be guided to do this over the phone or Zoom by a member of the research team.
Sponsors
Study design
Eligibility
Inclusion criteria
Common inclusion criteria: To be enrolled in this trial, all participants must meet the following eligibility criteria, in addition to the relevant specific inclusion criteria for their respective group, as below: • Aged between 10-25 years at the time of randomisation. • Has dysarthria. • Can speak in single words and short sentences. This is to ensure they can perform the speech tasks required for outcome measures in the trial. • Can provide a signed and dated informed consent form OR has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf. • Can commit to the time requirements of the trial. • Has English as a first language. • Has access to stable internet connection. This is to ensure they can perform the online assessment tasks and can connect the voice assistant device to the internet. • Is willing to use their existing Amazon account, or to create a new (free) account with guidance from the research team, for use during the trial. Specific inclusion criteria for Group A: PMG • Has a diagnosis of perisylvian PMG, confirmed by MRI report or letter from a neurologist. Specific inclusion criteria for Group B: FOXP1 syndrome • Has a diagnosis of FOXP1 syndrome, confirmed by genetic report showing a pathogenic or likely pathogenic FOXP1 variant according to the American College of Medical Genetics guidelines (Richards et al., 2015).
Exclusion criteria
• Has an additional, diagnosed genetic or neurological condition known to affect speech and language. • Visual or hearing problems that, in the view of the site principal investigator, significantly impact on the validity or reliability of speech testing. • Independently uses a voice assistant regularly (defined as use > twice every day) prior to commencing the trial.