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- W2011899692 abstract "Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions. Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions." @default.
- W2011899692 created "2016-06-24" @default.
- W2011899692 creator A5020962468 @default.
- W2011899692 date "2008-10-30" @default.
- W2011899692 modified "2023-10-08" @default.
- W2011899692 title "Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions" @default.
- W2011899692 cites W1500304413 @default.
- W2011899692 cites W1964217371 @default.
- W2011899692 cites W1965039541 @default.
- W2011899692 cites W1969250212 @default.
- W2011899692 cites W1969321104 @default.
- W2011899692 cites W1972494017 @default.
- W2011899692 cites W1975604841 @default.
- W2011899692 cites W1975625094 @default.
- W2011899692 cites W1977422042 @default.
- W2011899692 cites W1979028140 @default.
- W2011899692 cites W1981990510 @default.
- W2011899692 cites W1988545157 @default.
- W2011899692 cites W1988811462 @default.
- W2011899692 cites W1989281612 @default.
- W2011899692 cites W1989721900 @default.
- W2011899692 cites W1989914548 @default.
- W2011899692 cites W1992324078 @default.
- W2011899692 cites W1994520129 @default.
- W2011899692 cites W2003333272 @default.
- W2011899692 cites W2035927474 @default.
- W2011899692 cites W2036636643 @default.
- W2011899692 cites W2046692301 @default.
- W2011899692 cites W2049336432 @default.
- W2011899692 cites W2049929913 @default.
- W2011899692 cites W2050707309 @default.
- W2011899692 cites W2051821264 @default.
- W2011899692 cites W2052094662 @default.
- W2011899692 cites W2054733381 @default.
- W2011899692 cites W2058707871 @default.
- W2011899692 cites W2059022721 @default.
- W2011899692 cites W2064252774 @default.
- W2011899692 cites W2077708730 @default.
- W2011899692 cites W2080652684 @default.
- W2011899692 cites W2087734307 @default.
- W2011899692 cites W2093277078 @default.
- W2011899692 cites W2093302512 @default.
- W2011899692 cites W2094558159 @default.
- W2011899692 cites W2095339284 @default.
- W2011899692 cites W2095976292 @default.
- W2011899692 cites W2096001663 @default.
- W2011899692 cites W2098713215 @default.
- W2011899692 cites W2103966320 @default.
- W2011899692 cites W2107160767 @default.
- W2011899692 cites W2113995609 @default.
- W2011899692 cites W2114930732 @default.
- W2011899692 cites W2115309487 @default.
- W2011899692 cites W2115362480 @default.
- W2011899692 cites W2115902323 @default.
- W2011899692 cites W2116598271 @default.
- W2011899692 cites W2117981173 @default.
- W2011899692 cites W2120173481 @default.
- W2011899692 cites W2120300678 @default.
- W2011899692 cites W2123593006 @default.
- W2011899692 cites W2123767256 @default.
- W2011899692 cites W2126125637 @default.
- W2011899692 cites W2126828346 @default.
- W2011899692 cites W2126906108 @default.
- W2011899692 cites W2127072151 @default.
- W2011899692 cites W2131284635 @default.
- W2011899692 cites W2131968173 @default.
- W2011899692 cites W2132223945 @default.
- W2011899692 cites W2136192280 @default.
- W2011899692 cites W2136855535 @default.
- W2011899692 cites W2137616502 @default.
- W2011899692 cites W2137983259 @default.
- W2011899692 cites W2138578394 @default.
- W2011899692 cites W2140036652 @default.
- W2011899692 cites W2140806102 @default.
- W2011899692 cites W2142960568 @default.
- W2011899692 cites W2145017654 @default.
- W2011899692 cites W2149299222 @default.
- W2011899692 cites W2149357109 @default.
- W2011899692 cites W2149921882 @default.
- W2011899692 cites W2151679560 @default.
- W2011899692 cites W2155194814 @default.
- W2011899692 cites W2158641331 @default.
- W2011899692 cites W2160682566 @default.
- W2011899692 cites W2164870922 @default.
- W2011899692 cites W2167614804 @default.
- W2011899692 cites W2171988783 @default.
- W2011899692 cites W2174194863 @default.
- W2011899692 cites W3208416847 @default.
- W2011899692 cites W4240831985 @default.
- W2011899692 cites W4255919691 @default.
- W2011899692 doi "https://doi.org/10.1177/1545968309331863" @default.
- W2011899692 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/4099048" @default.
- W2011899692 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/19240197" @default.
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