Response definition | ARAT subtest 2 (grasp) primary outcome | ARAT total response | modified Rankin Scale | Barthel Index | FMA | One or more of ARAT, mRS or BI, (%) |
≥2 point improvement, (%) | >6 point improvement, (%) | >1 category improvement, (%) | >9 point improvement*, (%) | >10 point improvement†, (%) | ||
3 months | 1/23 (4) | 3/23 (13) | 7/23 (30) | 8/23 (35) | 4/10 (40) | 13/23 (57) |
6 months | 3/22 (14) | 4/22 (18) | 6/22 (27) | 7/22 (32) | 13/22 (59) | |
12 months | 3/20 (15) | 5/20 (25) | 7/20 (35) | 8/20 (40) | 3/10 (30) | 14/20 (70) |
*Improvement by the specified threshold could not be evaluated in three subjects in whom baseline score was 100 and three subjects in whom baseline score was 95.
†Response on Fugl-Meyer Assessment is ≥10 points on either Motor Function Upper Extremity score or Motor Function Lower Extremity score.
ARAT, signifies Action Research Arm Test; BI, Barthel Index; FMA, Fugl-Meyer Assessment; mRS, modified Rankin Scale.