BACKGROUND AND PURPOSE: The purpose of this study was to test the feasibility of conducting a randomized controlled trial to study the effectiveness of self-managed computer treatment for people with long-standing aphasia after stroke. METHOD: In this pilot single-blinded, parallel-group, randomized controlled trial participants with aphasia were allocated to self-managed computer treatment with volunteer support or usual care (everyday language activity). The 5-month intervention period was followed by 3 months without intervention to investigate treatment maintenance. RESULTS:Thirty-four participants were recruited. Seventeen participants were allocated to each group. Thirteen participants from the usual care group and 15 from the computer treatment group were followed up at 5 months. An average of 4 hours 43 minutes speech and language therapy time and 4 hours volunteer support time enabled an average of 25 hours of independent practice. The difference in percentage change in naming ability from baseline at 5 months between groups was 19.8% (95% CI, 4.4-35.2; P=0.014) in favor of the treatment group. Participants with more severe aphasia showed little benefit. Results demonstrate early indications of cost-effectiveness of self-managed computer therapy. CONCLUSIONS: This pilot trial indicates that self-managed computer therapy for aphasia is feasible and that it will be practical to recruit sufficient participants to conduct an appropriately powered clinical trial to investigate the effectiveness of self-managed computer therapy for people with long-standing aphasia. Clinical Trial Registration- www.controlled-trials.com. Unique identifier: ISRCTN91534629.
RCT Entities:
BACKGROUND AND PURPOSE: The purpose of this study was to test the feasibility of conducting a randomized controlled trial to study the effectiveness of self-managed computer treatment for people with long-standing aphasia after stroke. METHOD: In this pilot single-blinded, parallel-group, randomized controlled trial participants with aphasia were allocated to self-managed computer treatment with volunteer support or usual care (everyday language activity). The 5-month intervention period was followed by 3 months without intervention to investigate treatment maintenance. RESULTS: Thirty-four participants were recruited. Seventeen participants were allocated to each group. Thirteen participants from the usual care group and 15 from the computer treatment group were followed up at 5 months. An average of 4 hours 43 minutes speech and language therapy time and 4 hours volunteer support time enabled an average of 25 hours of independent practice. The difference in percentage change in naming ability from baseline at 5 months between groups was 19.8% (95% CI, 4.4-35.2; P=0.014) in favor of the treatment group. Participants with more severe aphasia showed little benefit. Results demonstrate early indications of cost-effectiveness of self-managed computer therapy. CONCLUSIONS: This pilot trial indicates that self-managed computer therapy for aphasia is feasible and that it will be practical to recruit sufficient participants to conduct an appropriately powered clinical trial to investigate the effectiveness of self-managed computer therapy for people with long-standing aphasia. Clinical Trial Registration- www.controlled-trials.com. Unique identifier: ISRCTN91534629.
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