Constraint-induced or multi-modal personalized aphasia rehabilitation (COMPARE): A randomized controlled trial for stroke-related chronic aphasia.

Abstract

RATIONALE:

The comparative efficacy and cost-effectiveness of constraint-induced and multi-modality aphasia therapy in chronic stroke are unknown.

AIMS AND HYPOTHESES:

In the COMPARE trial, we aim to determine whether Multi-Modal Aphasia Treatment (M-MAT) and Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) are superior to usual care (UC) for chronic post-stroke aphasia. Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia.

SAMPLE SIZE ESTIMATES:

A total of 216 participants (72 per arm) will provide 90% power to detect a 5-point difference on the WAB-R-AQ between CIAT-Plus or M-MAT and UC at α = 0.05.

METHODS AND DESIGN:

Prospective, randomized, parallel group, open-label, assessor blinded trial. Participants: Stroke >6 months; aphasia severity categorized using WAB-R-AQ. Computer-generated blocked and stratified randomization by aphasia severity (mild, moderate, and severe), to 3 arms: CIAT-Plus, M-MAT (both 30 h therapy over two weeks); UC (self-reported usual community care).

STUDY OUTCOMES:

WAB-R-AQ immediately post-intervention. Secondary outcomes: WAB-R-AQ at 12-week follow-up; naming scores, discourse measures, Communicative Effectiveness Index, Scenario Test, and Stroke and Aphasia Quality of Life Scale-39 g immediately and at 12 weeks post-intervention; incremental cost-effectiveness ratios compared with UC at 12 weeks.

DISCUSSION:

This trial will determine whether CIAT-Plus and M-MAT are superior and more cost-effective than UC in chronic aphasia. Participant subgroups with the greatest response to CIAT-Plus and M-MAT will be described.

• Authors: Miranda L Rose, David Copland, Lyndsey Nickels, Leanne Togher, Marcus Meinzer, Tapan Rai, Dominique A Cadilhac, Joosup Kim, Abby Foster, Marcella Carragher, Melanie Hurley, Erin Godecke
• Journal: International journal of stroke : official journal of the International Stroke Society (Int J Stroke) Vol. 14 Issue 9 Pg. 972-976 (12 2019) ISSN: 1747-4949 [Electronic] United States
• PMID: 31496440 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)

Topics

• Humans
• Aphasia (etiology, rehabilitation)
• Combined Modality Therapy
• Cost-Benefit Analysis
• Severity of Illness Index
• Single-Blind Method
• Stroke (complications)
• Stroke Rehabilitation (economics, methods)
• Treatment Outcome
• Randomized Controlled Trials as Topic
• Prospective Studies