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Designing a clinical trial for neurorehabilitation 

Designing a clinical trial for neurorehabilitation
Designing a clinical trial for neurorehabilitation

Bruce Dobkin

and Andrew Dorsch


May 26, 2016: This chapter has been re-evaluated and remains up-to-date. No changes have been necessary.

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date: 19 September 2021

The design, implementation, and analysis of clinical trials for the types of complex therapies needed to lessen impairments and disabilities that result from neurological diseases are reviewed. A multistep progression from feasibility testing in small groups of selected participants to the demonstration of efficacy in large-scale, multicentre randomized clinical trials is presented. Designs other than the ‘gold standard’ parallel-group trial can be used to optimize the contents of a new therapeutic strategy. Emphasis is placed on defining clinical characteristics and establishing a stable functional baseline for study participants. How the choices of outcome measure and comparison intervention affect the statistical and clinical significance of trial results are highlighted. Discussion of methodological concerns about randomization and blinded outcome assessment is followed by a review of common statistical confounders in neurorehabilitation trials. The use of consensus standards about trial reporting provides a valuable checklist for basic decisions in trial design.

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