Aphasia post stroke Circulatory System
Conditions
Interventions
Patients will be randomised at baseline (after consent and baseline assessment) in a 1:1 ratio to Intensive Language Action Therapy (ILAT) or usual care. Randomisation will be stratified by time post
Sponsors
University of Sheffield
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants: Participants who have aphasia at least one-month post stroke will be identified by therapists from within speech therapy databases or by the Stroke Association Communication Support worker. The research SLT will then screen potential participants using the following criteria, which were devised in line with previous studies of ILAT (Pulvermuller et al, 2001, Meinzer et al, 2007); 1. Participants with aphasia as a consequence of stroke (determined by research SLT) 2. Participants must be able to repeat spoken words (determined by research SLT) Volunteers: Volunteers will be identified through advertising with volunteering agencies such as Voluntary Action and the Stroke Association. Volunteers who are already working with in Northern Lincolnshire and Goole NHS Foundation Trust will also be invited express interest in this role. 1. Expressed interest in the role 2. Be a competent communicator as determined at interview 3. Be dynamic, patient and encouraging as determined at interview 4. Agree to criminal records and health checks 5. Be able to participate for a minimum of 8 hours per treatment group 6. Be able to attend training All volunteers will be subject to compliance with NHS trust volunteering protocols including Disclosure and Barring Service (DBS) and health checks, identification and general induction including confidentiality and infection control. Rather than honorary contracts being organised, volunteers will sign a code of conduct in accordance with the Department of Health’s (2011) volunteer guidelines and trust volunteering procedure. Carers: Carer participants are eligible to take part in the trial if they provide informal care to the trial participant including family members, spouses and friends. Speech and Language Therapy Assistants (SLTAs): A previous agreement has been made within the Speech and Language Therapy team to release SLTAs already working within the trust to participate in this trial. All SLTAs working within the trust will be eligible to participation in the trial. All SLTAs will have undergone DBS, health checks and induction and mandatory training in line with NHS employee requirements.
Exclusion criteria
Exclusion criteria: Participants: 1. Participants must not have any other cognitive or psychological conditions that would affect participation or consent such as memory problems, dementia or difficulties with attention as judged by consenting research SLT 2. Participants must not have excessive fatigue (as they need to be able to tolerate the intensive nature of ILAT) as determined by the research SLT, the potential participant themselves and their carer if available 3. Currently receiving intensive therapy at more than 2 hours of individual therapy per week Volunteers: Must not have any formal SLT training or experience with ILAT Carers: Does not meet inclusion criteria SLTAs: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to examine the feasibility of undertaking a randomised control trial to compare the clinical effectiveness of ILAT facilitated by trained assistants/laypersons with usual care. Therefore, the primary outcomes are; 1. Feasibility of recruitment to the main trial – number of participants recruited per month and in a 12-month period 2. Acceptability of the research procedures, as described by participants through interviews 3. Feasibility of randomisation and allocation to treatment arm (ILAT) through the description of how groups were formed, the time taken to form groups and the number of 4-month outcome measures completed within 1 month of the 4-month post randomisation timepoint 4. Appropriateness and acceptability of the clinical outcome measures for assessing the impact of ILAT - the extent to which the clinical outcome measure assessments measure the intended outcome of the intervention, and the acceptability to the participants indicated by completion rates and interview data | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes The secondary outcomes examine the feasibility of delivering ILAT using assistants and volunteers based on the following; 1. Acceptability of ILAT to participants, assistants and volunteers, as described by participants through qualitative interviews collected after participation in a treatment course 2. Feasibility of delivering ILAT by assistants and volunteers under the supervision of an experienced SLT through piloting the training and manualized procedures for the delivery of ILAT, examining the burden of supervision for the research SLT including the total number of hours and the number of supervision sessions required per ILAT course, collected during each treatment course 3. Treatment fidelity of ILAT, measured through the observation/video recording and analysis of a sample of treatment sessions 4. Facilitators and barriers to ILAT success, as described by participants through qualitative interviews collected after completion of a treatment course Clinical outcomes The primary clinical outcome measure is conversational ability at 4 months measured through video-recorded conversations rated using Therapy Outcome Measures (Enderby, John & Petheram, 2006) Activity scale following the procedure described by Hesketh et al (2008). Conversational ability will also be rated using the Impairment Scale of the TOMs. The following secondary clinical outcomes have also been selected to further examine the clinical impact of ILAT; 1. Naming ability and sentence production measured using the Comprehensive Aphasia Test Subtests: Naming objects and picture description (Swinburn, Porter & Howard, 2004) at baseline and 4 months 2. Participant rated perceptions of communication ability measured using the Communication Outcome After Stroke (patient rated outcome measure) (Long et al, 2008) at baseline and 4 months 3. Carers perceptions of participant communication ability measured using the Carer Communication Outcome After Stroke (carer rating of partic | — |
Countries
United Kingdom
Contacts
Public ContactNicola Crook
Outcome results
None listed