OBJECTIVETo determine the clinical effectiveness, cost-effectiveness and service users' views of enhanced early communication therapy by speech and language (SL) therapists compared with attention control (AC).DESIGNSuccessful feasibility study followed by a randomised trial with economic evaluation, and nested qualitative study using 32 individual interviews.SETTINGTwelve English NHS hospital and community stroke services.PARTICIPANTSOne hundred and seventy adults with aphasia or dysarthria admitted to hospital with stroke, December 2006 to January 2010. Eligibility determined by NHS SL therapists. Seventeen people declined follow-up.INTERVENTIONSA best-practice, flexible intervention by NHS SL therapists, up to three contacts per week for up to 16 weeks compared with a similar number of AC contacts by employed visitors.MAIN OUTCOME MEASURESPrimary outcome was blinded, functional communicative ability 6 months post randomisation on the Therapy Outcome Measure activity subscale (TOM). Secondary outcomes were participants' perceptions on the Communication Outcomes After Stroke scale (COAST); carers' perceptions of participants from part of the Carer COAST; carer well-being on Carers of Older People in Europe Index and quality-of-life items from Carer COAST. Serious adverse events (SAEs) were recorded. Economic evaluation: participants' utility (European Quality of Life-5 Dimensions), service use and cost data from medical records and carers, and a discrete choice experiment.RESULTSIntervention typically started after 2 weeks, providing 22 contacts. Both groups improved on the TOM. The estimated 6 months' group difference [95% confidence interval (CI)] was 0.25 (-0.19 to 0.69) points in favour of SL therapy. Sensitivity analyses adjusting for baseline chance imbalance or not imputing values for decedents further reduced this difference. Per-protocol analyses rejected a possible dilution of therapy from controls refusing allocation and receiving NHS SL therapy. There was no evidence of added benefit of therapy on any secondary outcome measure or SAEs, although the latter were less frequent in the therapy group [odds ratio 0.42 (95% CI 0.16 to 1.1)]. Regardless of group allocation, interviewed participants reported positive impacts on their confidence and mood, identified drivers for change and valued early and sustained contact. Health economic analysis indicated a high level of uncertainty. Early enhanced SL therapy for communication is likely to be cost-effective only if decision-makers are prepared to pay ≥ £25,000 to gain one unit of utility.CONCLUSIONSThese findings exclude the possibility of a clinically significant difference of 0.5 points on the TOM. There was no evidence, on any measure, of added benefit of early communication therapy beyond that from AC. It is unclear whether therapy is more or less cost-effective than AC. Early, frequent contact was highly valued by users and had good uptake. Functional communication improved for both groups, plausibly due to natural recovery and early and regular opportunity to practise everyday communication with a professional (therapist/visitor). There is no evidence to recommend enhancing the provision of early communication therapy by a qualified SL therapist over and above usual care. SL therapy service reorganisation should consider skill mix and timing within a stepped care model and should take place within the context of a trial.
It is encouraging to see the Royal College of Speech and Language Therapists supporting randomised controlled trials (RCTs).1 2 Meteyard worries that RCTs will not cope with the complexity inherent after stroke.3 However, many RCTs have demonstrated the effectiveness of a range of complex interventions for heterogeneous populations (for example, stroke unit care, occupational therapy). As Enderby notes, the Cochrane review finds …
This paper describes a study protocol to investigate the use of immersive virtual reality as a treatment for amputees' phantom limb pain. This work builds upon prior research using mirror box therapy to induce vivid sensations of movement originating from the muscles and joints of amputees' phantom limbs. The present project transposes movements of amputees' anatomical limbs into movements of a virtual limb presented in the phenomenal space of their phantom limb. It is anticipated that the protocol described here will help reduce phantom limb pain.
Purpose . This paper describes the design and implementation of a case study based investigation using immersive virtual reality as a treatment for phantom limb pain. Method . Three participants who experienced phantom limb pain (two with an upper-limb amputation, and one with a lower-limb amputation) took part in between 2 and 5 immersive virtual reality (IVR) sessions over a 3-week period. The movements of participants’ anatomical limbs were transposed into the movements of a virtual limb, presented in the phenomenal space of their phantom limb. Results . Preliminary qualitative findings are reported here to assess proof of principle for this IVR equipment. All participants reported the transferal of sensations into the muscles and joints of the phantom limb, and all participants reported a decrease in phantom pain during at least one of the sessions. Conclusion . The authors suggest the need for further research using control trials.