scholarly journals A Randomized Controlled Trial on Very Early Speech and Language Therapy in Acute Stroke Patients with Aphasia

2011 ◽  
Vol 1 (1) ◽  
pp. 66-74 ◽  
Author(s):  
A.C. Laska ◽  
T. Kahan ◽  
A. Hellblom ◽  
V. Murray ◽  
M. von Arbin
Keyword(s):  
Randomized Controlled Trial ◽  
Acute Stroke ◽  
Controlled Trial ◽  
Speech And Language ◽  
Language Therapy ◽  
Stroke Patients ◽  
Speech And Language Therapy ◽  
Randomized Controlled ◽  
Early Speech

scholarly journals Trial participants’ experiences of early enhanced speech and language therapy after stroke compared with employed visitor support: a qualitative study nested within a randomized controlled trial

2012 ◽  
Vol 27 (2) ◽  
pp. 174-182 ◽  
Author(s):  
Alys Young ◽  
Timothy Gomersall ◽  
Audrey Bowen ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Qualitative Study ◽  
Controlled Trial ◽  
Speech And Language ◽  
Language Therapy ◽  
Speech And Language Therapy ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
The Impact ◽  
Trial Participants

Objectives: To explore trial participants’ experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Design: Qualitative study nested within a randomized controlled trial. Participants: Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Setting: Eight English NHS usual care settings. Method: Individual interviews. Thematic content analysis assisted by a bespoke data transformation protocol for incorporating non-verbal and semantically ambiguous data. Results: Participants highly regarded regular and sustained contact with someone outside of immediate family/friends who engaged them in deliberate activities/communication in the early months after stroke. Participants identified differences in the process of intervention between speech and language therapists and employed visitors. But no major discriminations were made between the impact or value of this contact according to whether provided by a speech and language therapist or employed visitor. Participant-defined criteria for effectiveness of contact included: impact on mood and confidence, self-recognition of progress and the meeting of individual needs. Conclusions: As in the randomized controlled trial, participants reported no evidence of added benefit of early communication therapy beyond that from attention control. The findings do not imply that regular contact with any non-professional can have beneficial effects for someone with aphasia or dysarthria in the early weeks following a stroke. The study points to specific conditions that would have to be met for contact to have a positive effect.

Abstract NS4: Challenges and Lessons Learned in an Ongoing Randomized Controlled Trial to Test the Effectiveness of a Multicomponent Intervention in Improving Delirium Outcomes in Acute Stroke

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Karen L Rice ◽  
Marsha Bennett ◽  
Linley Berger ◽  
Bethany Jennings ◽  
Erin Barry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Acute Stroke ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Intervention Fidelity ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Multicomponent Intervention ◽  
Study Staff ◽  
Therapeutic Activities

Delirium in acute stroke has higher morbidity and mortality than those without delirium. This two-group randomized controlled trial (RCT) tests if a multicomponent intervention improves delirium outcomes in stroke patients at a comprehensive stroke center. This presentation describes the challenges in managing a RCT in acute stroke. Scientific rigor requires coordinating staff, enrolling adequate sample size, assuring intervention fidelity, and fostering data integrity. A sample of 282 subjects is required for 80% power (α=0.05) to determine a 10% reduction in incident delirium. Eligibility includes acute stroke, aged ≥ 50 years, no aphasia or delirium on admit. Subjects randomized to Usual Care (UC) or Delirium Care (DC). Both groups receive standardized Stroke Care. DC subjects receive a multicomponent intervention: 1) pharmacist recommendations using Anticholinergic Drug scale scores; and 2) therapeutic activities. NIHSS, Montreal Cognitive Assessment (MoCA), Confusion Assessment Method (CAM), and mRS are used to determine primary (delirium) and secondary endpoints (LOS, neurological deficit, functional status). A total of 513 patients screened over 289 consecutive days required unbudgeted staff. The 310 excluded [aphasia (94), baseline delirium (36), critically ill (92), LOS <2 days (69), other causes (19)] unexpectedly impacted enrollment. Of eligible, 66% (133/203) consented; UC (n=65), DC (n=68). Hospital volunteers engaged DC subjects in therapeutic activities twice daily, including holidays. Two pharmacists independently made recommendations for each group. Outcome data were validated at daily rounds. Stroke-related cognitive dysfunction required more time than norm to complete the MoCA. Both the CAM and team consensus was used to confirm delirium. Lessons learned: 1) study staff attending rounds was key to enrollment, intervention fidelity, and data integrity; 2) securing a pool of on-call volunteers to sustain therapeutic activities was required; and 3) additional and unanticipated resources were needed. In conclusion, successful conduct of a RCT in acute stroke patients requires a dedicated well-trained study staff 7 days a week, including holidays.

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