None listed
Conditions
Brief summary
The study will compare different treatments for people with aphasia. Participants will randomly assigned to one of three treatment groups CIAT, M-MAT or Usual Care. Participants will attend baseline assessments, a two week treatment period, assessment immediately after treatment and further follow up assessment 12 weeks after completing the treatment. Participants randomised to the Usual Care group will be offered additional treatment at the end of the 12 week follow up period as part of an optional sub-study. In this sub-study participants will be re-randomised to receive either CIAT or M-MAT. They will attend treatment visits over five weeks with follow up assessments immediately after the treatment period and again at 12 weeks after completing the treatment. Study Hypothesis: Compared to usual care, both the study treatments (CIAT and M-MAT) will result in reduced aphasia severity .
Interventions
Arm 1: Constraint Induced Aphasia Therapy (CIAT):
CIAT involves participants producing nouns, verbs, and functional phrases that they have not been able to produce prior to treatment, in response to pictured object and action cards, in a small social group setting. Physical visual barriers between participants discourage the use of gesture, drawing or writing as alternative means of communication when speech fails. Communication activities include requesting picture cards from group members (e.
Arm 1: Constraint Induced Aphasia Therapy (CIAT): CIAT involves participants producing nouns, verbs, and functional phrases that they have not been able to produce prior to treatment, in response to pictured object and action cards, in a small social group setting. Physical visual barriers between participants discourage the use of gesture, drawing or writing as alternative means of communication when speech fails. Communication activities include requesting picture cards from group members (e.g., Do you have 'coffee'?), responding to requests from others (e.g., “Yes I have 'coffee'”), and rehearsal of functional communication routines (e.g., role playing being in a shop asking for coffee). Clinicians explicitly cue and shape the verbal responses such that, as performance improves, participant responses are shaped from simple, single word requests (e.g., “Coffee?”) through to more elaborate sentences (e.g., “John, I want a large, black coffee?”). CIAT Plus developed by CI Meinzer and colleagues also includes daily home practice (monitored via written log/carer report), which we will utilize in this study. There will be 30 hrs of treatment (3hrs/day, 5 days/week for 2 weeks), in a small group setting (2-3 participants per group) with one qualified speech pathologist. Arm 2: Multi-Modality Aphasia Therapy (M-MAT): M-MAT involves the same communication activities in the same setting as CIAT (socially inspired card based requesting and responding), but there are no visual barriers between participants. Clinicians explicitly cue and shape the verbal responses from participants with a series of structured multi-modal prompts that participants copy: associated gesture, written word, simple drawing, and verbal repetition. Daily home practice tasks are set and monitored via written log/carer report. There will be 30hrs of treatment (3hrs/day, 5 days/week for 2 weeks), in a small group setting (3 participants per group) with one qualified speech pathologist. Optional Sub-Study for ARM 3 Usual Care For ethical reasons, at the end of the 12 week follow up assessments participants randomised to ARM 3 Usual Care will be offered M-MAT or CIAT treatment equal in overall dose to that of the intervention participants. These participants will be re-randomised to either non-intense M-MAT or non-intense CIAT. Non-intense M-MAT and CIAT are equivalent in every respect to intense M-MAT and CIAT except that the treatment schedule is 2 hours per day, 3 days per week for 5 weeks duration (instead of 3 hours per day, 5 days per week for 2 weeks duration) in a small group setting (2-3 participants per group) with one qualified speech pathologist. This treatment data will be collected but not used in the primary or secondary statistical analysis of this trial. This data will be used in tertiary analyses to provide pre vs post views of treatment gains, where each participant is their own control, as well as a preliminary comparison of overall effect sizes from intense versus non-intense CIAT and M-MAT.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria Participants will be included if they: 1. Have a documented stroke resulting in aphasia at least 6 months prior to assessment at the time of consent 2. Have aphasia of any type (<93.8 WAB-AQ) 3. Used English as their primary language prior to stroke 4. Are 18 years or older and able to give informed consent 5. Are independent in toileting 6. Are able and willing to attend/participate in baseline assessments, 2 week treatment period, post-intervention period and follow up period 7. Have a carer/significant other who is able and willing to participate in baseline, post-intervention and follow up assessments. The sub-study is optional for participants randomized to the UC group and as such willingness to participate in the sub-study is not a limiting factor for inclusion into the study. Carer/significant other as nominated by the participant will be included if they: 1. Are 18 years or older and able to give informed consent 2. Are able and willing to participate in baseline, post-intervention period and follow up assessments A carer/significant other is nominated by the participant and is not a limiting factor for inclusion into the study.
Exclusion criteria
Exclusion criteria Participants will not be included if they: 1. Have had previous neurological event/diagnosis (head injury, neurosurgery, dementia, epilepsy, progressive neurological disorder) other than stroke 2. Have severe apraxia of speech or dysarthria on Apraxia Severity Rating Scale. 3. Have been diagnosed major clinical depression or other mental health condition that may affect involvement or adherence to the study protocol 4. Have uncorrected sensory loss (hearing/vision) preventing participation in communication assessments and treatments 5. Are unable to attend the 12 week follow-up assessments 6. Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the protocol. 7. Are participating in any other therapy (including alternative therapies and clinical trials) or taking medications (including herbal preparations) that are not considered to be standard care for people with aphasia.
Outcome results
None listed