ReaDySpeech for people with dysarthria after stroke: protocol for a feasibility randomised controlled trial
Posted on 2017-07-20 - 05:00
Abstract Background Dysarthria, a disordered speech production resulting from neuro-muscular impairment, is a common symptom after stroke. It causes significant problems for patients’ speech intelligibility, communication, psychological well-being, social engagement and stroke recovery. Rehabilitation for dysarthria is variable in quality, intensity and duration, which may be, in part, due to the lack of good quality evidence. An online therapy programme, ReaDySpeech, has the potential to improve quality, intensity and duration of speech rehabilitation and was considered in a proof-of-concept study to be acceptable to speech and language therapists and patients which warranted further evaluation. The present study aims to examine the feasibility of running a trial using the ReaDySpeech intervention. Methods/design A feasibility, randomised controlled trial, will recruit a minimum of 36 people with post-stroke dysarthria who are more than 1 week post stroke. Participants will be externally randomised in a 2:1 ratio to receive either ReaDySpeech and usual care (24 participants) or usual care only (12 participants). This study is single blind with the researcher carrying out the baseline and outcome measures while blinded to treatment allocation. The primary objective is to assess the feasibility of conducting a larger Phase III trial. The specific objectives are to determine the following: recruitment rate and reasons for non-recruitment; loss of participants to follow-up; acceptability of randomisation; adherence to the intervention; delivery of ReaDySpeech and content; acceptability of outcome measures; success of blinding strategies; defining ‘usual’ care; and the implications of the intervention for the patient/family/carer. Discussion This study will involve a regional, multi-centre, randomised controlled feasibility trial of a complex intervention in order to evaluate whether a Phase III randomised controlled trial is feasible. Trial registration Current Controlled Trials, ISRCTN84996500
CITE THIS COLLECTION
DataCiteDataCite
3 Biotech3 Biotech
3D Printing in Medicine3D Printing in Medicine
3D Research3D Research
3D-Printed Materials and Systems3D-Printed Materials and Systems
4OR4OR
AAPG BulletinAAPG Bulletin
AAPS OpenAAPS Open
AAPS PharmSciTechAAPS PharmSciTech
Abhandlungen aus dem Mathematischen Seminar der Universität HamburgAbhandlungen aus dem Mathematischen Seminar der Universität Hamburg
ABI Technik (German)ABI Technik (German)
Academic MedicineAcademic Medicine
Academic PediatricsAcademic Pediatrics
Academic PsychiatryAcademic Psychiatry
Academic QuestionsAcademic Questions
Academy of Management DiscoveriesAcademy of Management Discoveries
Academy of Management JournalAcademy of Management Journal
Academy of Management Learning and EducationAcademy of Management Learning and Education
Academy of Management PerspectivesAcademy of Management Perspectives
Academy of Management ProceedingsAcademy of Management Proceedings
Academy of Management ReviewAcademy of Management Review
Mitchell, Claire; Bowen, Audrey; Tyson, Sarah; Conroy, Paul (2017). ReaDySpeech for people with dysarthria after stroke: protocol for a feasibility randomised controlled trial. figshare. Collection. https://doi.org/10.6084/m9.figshare.c.3832369.v1