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Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial
2019
Post-stroke aphasia might improve over many years with speech and language therapy; however speech and language therapy is often less readily available beyond a few months after stroke. We assessed self-managed computerised speech and language therapy (CSLT) as a means of providing more therapy than patients can access through usual care alone.
In this pragmatic, superiority, three-arm, individually randomised, single-blind, parallel group trial, patients were recruited from 21 speech and language therapy departments in the UK. Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy. Participants were randomly assigned (1:1:1) to either 6 months of usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation (randomly ordered blocks of sizes three and six, stratified by site and severity of word finding at baseline based on CAT Naming Objects test scores). Only the outcome assessors and trial statistician were masked to the treatment allocation. The speech and language therapists who were doing the outcome assessments were different from those informing participants about which group they were assigned to and from those delivering all interventions. The statistician responsible for generating the randomisation schedule was separate from those doing the analysis. Co-primary outcomes were the change in ability to retrieve personally relevant words in a picture naming test (with 10% mean difference in change considered a priori as clinically meaningful) and the change in functional communication ability measured by masked ratings of video-recorded conversations, with the use of Therapy Outcome Measures (TOMs), between baseline and 6 months after randomisation (with a standardised mean difference in change of 0·45 considered a priori as clinically meaningful). Primary analysis was based on the modified intention-to-treat (mITT) population, which included randomly assigned patients who gave informed consent and excluded those without 6-month outcome measures. Safety analysis included all participants. This trial has been completed and was registered with the ISRCTN, number ISRCTN68798818.
From Oct 20, 2014, to Aug 18, 2016, 818 patients were assessed for eligibility, of which 278 (34%) participants were randomly assigned (101 [36%] to the usual care group; 97 [35%] to the CSLT group; 80 [29%] to the attention control group). 86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT. Mean word finding improvements were 1·1% (SD 11·2) in the usual care group, 16·4% (15·3) in the CSLT group, and 2·4% (8·8) in the attention control group. Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group. Mean changes in TOMs were 0·05 (SD 0·59) in the usual care group (n=84), 0·04 (0·58) in the CSLT group (n=81), and 0·10 (0·61) in the attention control group (n=68); the mean difference in change between the CSLT and usual care groups was –0·03 (–0·21 to 0·14; p=0·709) and between the CSLT and attention control groups was –0·01 (–0·20 to 0·18). The incidence of serious adverse events per year were rare with 0·23 events in the usual care group, 0·11 in the CSLT group, and 0·16 in the attention control group. 40 (89%) of 45 serious adverse events were unrelated to trial activity and the remaining five (11%) of 45 serious adverse events were classified as unlikely to be related to trial activity.
CSLT plus usual care resulted in a clinically significant improvement in personally relevant word finding but did not result in an improvement in conversation. Future studies should explore ways to generalise new vocabulary to conversation for patients with chronic aphasia post-stroke.
National Institute for Health Research, Tavistock Trust for Aphasia.
Journal Article
Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting
by
Som, O'N
,
Regenbrecht, Frank
,
Schillikowski, E
in
Active control
,
Activities of daily living
,
Adolescent
2017
Treatment guidelines for aphasia recommend intensive speech and language therapy for chronic (≥6 months) aphasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness are scarce. We aimed to examine whether 3 weeks of intensive speech and language therapy under routine clinical conditions improved verbal communication in daily-life situations in people with chronic aphasia after stroke.
In this multicentre, parallel group, superiority, open-label, blinded-endpoint, randomised controlled trial, patients aged 70 years or younger with aphasia after stroke lasting for 6 months or more were recruited from 19 inpatient or outpatient rehabilitation centres in Germany. An external biostatistician used a computer-generated permuted block randomisation method, stratified by treatment centre, to randomly assign participants to either 3 weeks or more of intensive speech and language therapy (≥10 h per week) or 3 weeks deferral of intensive speech and language therapy. The primary endpoint was between-group difference in the change in verbal communication effectiveness in everyday life scenarios (Amsterdam–Nijmegen Everyday Language Test A-scale) from baseline to immediately after 3 weeks of treatment or treatment deferral. All analyses were done using the modified intention-to-treat population (those who received 1 day or more of intensive treatment or treatment deferral). This study is registered with ClinicalTrials.gov, number NCT01540383.
We randomly assigned 158 patients between April 1, 2012, and May 31, 2014. The modified intention-to-treat population comprised 156 patients (78 per group). Verbal communication was significantly improved from baseline to after intensive speech and language treatment (mean difference 2·61 points [SD 4·94]; 95% CI 1·49 to 3·72), but not from baseline to after treatment deferral (−0·03 points [4·04]; −0·94 to 0·88; between-group difference Cohen's d 0·58; p=0·0004). Eight patients had adverse events during therapy or treatment deferral (one car accident [in the control group], two common cold [one patient per group], three gastrointestinal or cardiac symptoms [all intervention group], two recurrent stroke [one in intervention group before initiation of treatment, and one before group assignment had occurred]); all were unrelated to study participation.
3 weeks of intensive speech and language therapy significantly enhanced verbal communication in people aged 70 years or younger with chronic aphasia after stroke, providing an effective evidence-based treatment approach in this population. Future studies should examine the minimum treatment intensity required for meaningful treatment effects, and determine whether treatment effects cumulate over repeated intervention periods.
German Federal Ministry of Education and Research and the German Society for Aphasia Research and Treatment.
Journal Article
Parent-Implemented Enhanced Milieu Teaching With Preschool Children Who Have Intellectual Disabilities
2013
Purpose: The purpose of this study was to compare the effects of enhanced milieu teaching (EMT) implemented by parents and therapists versus therapists only on the language skills of preschool children with intellectual disabilities (IDs), including children with Down syndrome and children with autism spectrum disorders. Method: Seventy-seven children were randomly assigned to 2 treatments (parent + therapist EMT or therapist-only EMT) and received 36 intervention sessions. Children were assessed before, immediately after, 6 months after, and 12 months after intervention. Separate linear regressions were conducted for each standardized and observational measure at each time point. Results: Parents in the parent + therapist group demonstrated greater use of EMT strategies at home than untrained parents in the therapist-only group, and these effects maintained over time. Effect sizes for observational measures ranged from d = 0.10 to d = 1.32 favoring the parent + therapist group, with the largest effect sizes found 12 months after intervention. Conclusion: Findings from this study indicate generally that there are benefits to training parents to implement naturalistic language intervention strategies with preschool children who have ID and significant language impairments.
Journal Article
Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson’s disease (PD COMM): pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial
2024
AbstractObjectivesTo assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson’s disease.DesignPragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial.SettingThe speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020.Participants388 people with Parkinson’s disease and dysarthria.InterventionsParticipants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants’ needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle.Main outcome measuresThe primary outcome was total score at three months of self-reported voice handicap index.ResultsPeople who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (−8.0 points (99% confidence interval −13.3 to −2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (−3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (−9.6 points (−14.9 to −4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded.ConclusionsLSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy.Trial registrationISRCTN registry ISRCTN12421382.
Journal Article
Right C7 neurotomy at the intervertebral foramen plus intensive speech and language therapy versus intensive speech and language therapy alone for chronic post-stroke aphasia: multicentre, randomised controlled trial
2025
AbstractObjectiveTo evaluate whether right neurotomy of the seventh cervical nerve (C7) at the intervertebral foramen plus intensive speech and language therapy (SLT) improves language function compared intensive SLT alone in patients with chronic aphasia after stroke.DesignMulticentre, assessor blinded, randomised controlled trial.SettingFour centres in mainland China.Participants50 adults aged 40-65 years with aphasia for more than one year after a single left hemispheric stroke.InterventionsParticipants were randomised 1:1 to receive either C7 neurotomy plus three weeks of intensive SLT or three weeks of intensive SLT only, stratified by treatment centre.Main outcome measuresThe primary outcome was change in score on the 60 item Boston naming test (BNT, scores 0-60, with higher scores indicating better naming function) from baseline to one week after C7 neurotomy plus intensive SLT for three weeks or intensive SLT for three weeks after deferral for one week (control group). Secondary outcomes included change in severity of aphasia using the aphasia quotient, calculated using the western aphasia battery, and patient reported outcomes on quality of life and depression after stroke.ResultsFrom 25 July 2022 to 31 July 2023, 322 out of 1086 patients received a diagnosis of post-stroke aphasia and were screened for eligibility. 50 eligible participants were randomly assigned to treatment groups (25 in each). Mean increase in BNT score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group at one month (difference 8.51 points, 95% confidence interval (CI) 5.31 to 11.71, P<0.001). The between group difference in BNT score remained stable at six months (difference 8.26 points, 4.16 to 12.35, P<0.001). In addition, the aphasia quotient improved significantly in the neurotomy plus SLT group versus control group (difference at one month 7.06 points, 4.41 to 9.72, P<0.001), as did patient reported activities of daily living and post-stroke depression. No treatment related severe adverse events were reported.ConclusionsC7 neurotomy plus three weeks of intensive SLT was associated with a greater improvement in language function compared with three weeks of intensive SLT alone over a period of six months. No severe adverse events or long term troublesome symptoms or functional loss were reported.Trial registrationChinese Clinical Trial Register ChiCTR2200057180.
Journal Article
Variability in the Language Input to Children Enhances Learning in a Treatment Context
by
Lieser, Anne Marie
,
Ogilvie, Trianna
,
Burton, Rebecca
in
Artificial languages
,
Child, Preschool
,
Children
2014
Artificial language learning studies have demonstrated that learners exposed to many different nonword combinations representing a grammatical form demonstrate rapid learning of that form without explicit instruction. However, learners presented with few exemplars, even when they are repeated frequently, fail to learn the underlying grammar. This study translated this experimental finding in a therapeutic context.
Eighteen preschool children with language impairment received conversational recast treatment for morpheme errors. Over a 6-week period, half heard 12 unique verbs twice each during recasts (low-variability condition), and half heard 24 unique verbs (high-variability condition). Children's use of trained and untrained morphemes on generalization probes as well as spontaneous use of trained morphemes was tracked throughout treatment.
The high-variability condition only produced significant change in children's use of trained morphemes, but not untrained morphemes. Data from individual children confirmed that more children in the high- than the low-variability condition showed a strong treatment effect. Children in the high-variability condition also produced significantly more unique utterances containing their trained morpheme than children in the low-variability condition.
The results support the use of highly variable input in a therapeutic context to facilitate grammatical morpheme learning.
Journal Article
Using Pivotal Response Treatment to Improve Language Functions of Autistic Children in Special Schools: A Randomized Controlled Trial
by
Wang, Chongying
,
Li, Shuting
,
Wang, Leilei
in
Adaptive behavior
,
Autism
,
Autism Spectrum Disorders
2024
Language difficulties exert profound negative effects on the cognitive and social development of autistic children. Pivotal Response Treatment (PRT) is a promising intervention for improving social communication in autistic children, but there is a lack of a comprehensive examination of language functions. This study aimed to investigate the effectiveness of PRT in promoting the primary language functions (requesting, labeling, repeating, responding) defined by (Skinner, B. F. (1957). Verbal behavior. Martino Publishing.) theory of verbal behavior in autistic children. Thirty autistic children were randomly divided into the PRT group (
M
age
= 6.20,
SD
age
= 1.21) and control group (
M
age
= 6.07,
SD
age
= 1.49). The PRT group were provided with an 8-week training of the PRT motivation component in addition to treatment as usual (TAU) in their schools, whereas the control group only received TAU. Parents of the PRT group were also trained to practice the PRT motivation procedures at home. The PRT group demonstrated greater improvements in all four measured language functions compared to the control group. The improvement in language functions in the PRT group was generalized and maintained at the follow-up assessment. In addition, the PRT intervention enhanced untargeted social and communicative functioning, cognition, motor skills, imitation, and adaptive behaviors in the autistic children. In conclusion, language intervention using the motivation component of PRT is effective in promoting language functions as well as widespread untargeted cognitive and social functions in autistic children.
Journal Article
Evaluation of an Explicit Intervention to Teach Novel Grammatical Forms to Children With Developmental Language Disorder
2018
Purpose: Unlike traditional implicit approaches used to improve grammatical forms used by children with developmental language disorder, explicit instruction aims to make the learner consciously aware of the underlying language pattern. In this study, we compared the efficacy of an explicit approach to an implicit approach when teaching 3 novel grammatical forms varying in linguistic complexity. Method: The study included twenty-five 5- to 8-year-old children with developmental language disorder, 13 of whom were randomized to receive an implicit-only (I-O) intervention whereas the remaining 12 participants were randomized to receive a combined explicit-implicit (E-I) intervention to learn 3 novel grammatical forms. On average, participants completed 4.5 teaching sessions for each form across 9 days. Acquisition was assessed during each teaching session. Approximately 9 days posttreatment for each form, participants completed probes to assess maintenance and generalization. Results: Analyses revealed a meaningful and statistically significant learning advantage for the E-I group on acquisition, maintenance, and generalization measures when performance was collapsed across the 3 novel targets (p < 0.02, [phi]s > 0.60). Significant differences between the groups, with the E-I group outperforming the I-O group, only emerged for 1 of the 3 target forms. However, all effect sizes ranged from medium to large ([phi]s = 0.25-0.76), and relative risk calculations all exceeded 0, indicating a greater likelihood of learning the target form with E-I instruction than I-O instruction. Conclusions: Study findings indicate that, as compared to implicit instruction, children are more likely to acquire, maintain, and generalize novel grammatical forms when taught with explicit instruction. Further research is needed to evaluate the use of explicit instruction when teaching true grammatical forms to children with language impairment.
Journal Article
Technology and Dementia Preconference
by
Rademaker, Alfred
,
Fegter, Ollie
,
Bona, Matthew
in
Aged
,
Aged, 80 and over
,
Aphasia, Primary Progressive - rehabilitation
2025
Primary Progressive Aphasia (PPA) is a clinical dementia syndrome characterized by progressive language decline. Access to care for individuals living with PPA is limited by a shortage of evidence-based interventions and qualified clinicians. While technology-supported approaches show promise in improving access to care, there has been no systematic exploration of the factors affecting web application use in this population. This study evaluated the usage and feasibility of an app-based intervention through quantitative application engagement data and qualitative insights from semi-structured post-study interviews.
Participants enrolled in Communication Bridge-2 (NCT03371706, n = 95), a 12-month NIH stage 2 randomized controlled trial of speech-language therapy for PPA, were encouraged to complete app-based home practice exercises five days per week for 30 minutes per day. Usage was measured by weekly logins and completed home practice exercises. Feasibility was assessed through semi-structured post-study interviews (PSI; n = 79). Multi-methods analysis incorporated descriptive statistics and thematic coding of qualitative data.
On average, participants logged into the app 5.88 times per week (SD=1.29, range 1.29-18.90) to access exercises and educational materials across the ∼12-month duration of the intervention. On average, users completed 13.7 home practice exercises (SD=5.95) across 3.99 days per week (SD=1.19). PSI dyadic reports indicated few technical challenges with the application (n = 76, 85%) with the most common issues including software updates (n = 12) or connectivity problems (n = 10). Most (n = 80, 90%) found the computer-based format helpful, and many (n = 26, 29%) described the app as user-friendly and intuitive after initial training. Participants highlighted the app's role in fostering confidence and motivation for home communication practice.
This study demonstrates high usage and feasibility of web applications to support communication and language intervention in PPA. Importantly, all participants logged into the app and completed home practice exercises at least weekly. Most participants experienced minimal technical challenges and found the web-based format easy to use following a brief technology orientation. These findings challenge assumptions about technology use in older adults with cognitive-communication impairments and provide support for web applications as viable tools for supporting evidence-based speech-language home practice exercises and educational videos to individuals with PPA and their communication partners.
Journal Article