Very early poststroke aphasia therapy: A pilot randomized controlled efficacy trial

Background and purpose: Early stroke rehabilitation has shown benefits over spontaneous recovery. Insufficient evidence exists to determine the benefits of early aphasia intervention. We hypothesized that daily aphasia therapy would show better communication outcomes than usual care (UC) in early poststroke recovery. Method: This prospective, randomized, single-blinded, controlled trial was conducted in three acute-care hospitals in Perth, Australia, each with over 200 stroke admissions annually. Patients with acute stroke causing moderate to severe aphasia were recruited at a median of three-days (range: 0–10 days) to receive daily aphasia therapy or usual care therapy. Individually tailored, impairment-based intervention was provided for the acute hospital stay or intervention phase (median: 19 days; range: 5–76). Primary outcome measures were the aphasia quotient and functional communication profile at acute hospital discharge or four-weeks poststroke, whichever came first. A random-number generator and sealed envelopes were used to randomize participants. Assessments were completed by a blinded assessor. Results: Fifty-nine participants were recruited, with six withdrawals (10%) and seven deaths (12%) at six-months. Ninety percent had ischemic strokes, with 56·5% experiencing a total anterior circulation stroke. The group mean (±SD) age was 69·1 (±13·9) years. Six participants (18·75%) in the daily aphasia therapy group did not complete the minimum (150 min) therapy required for this study. The daily aphasia therapy intervention phase mean therapy session time was 45 min (range: 30–80) and the total mean amount of therapy for the daily aphasia therapy participants was 331 min (range: 30–1415). Four (15%) participants in the usual care group received therapy. The collective total therapy provided to these participants was 295 min over seven sessions. Usual care participants received an average of 10·5 min of therapy per week during the intervention phase. At the primary end point, a generalized estimating equations model demonstrated that after controlling for initial aphasia severity, participants receiving daily aphasia therapy scored 15·1 more points (P=0·010) on the aphasia quotient and 11·3 more points (P=0·004) on the functional communication profile than those receiving usual care therapy. Conclusions: Daily aphasia therapy in very early stroke recovery improved communication outcomes in people with moderate to severe aphasia