The clinical effectiveness was shown in a group study with 52 patients who improved in motor functions and spasticity highly significant. The BCI treatment used here was effective in promoting long lasting functional improvements in the upper extremity in stroke survivors with severe, moderate and mild impairment. This functional improvement can be explained by improved neuroplasticity in the central nervous system.
The recoveriX PRO study investigated 52 patients (3.3 years after stroke) with a mean FMA-UE (Fugl-Meyer Assessment of Upper Extremities) at baseline of 17.0 points. The study showed a signifanct improvement of FMA-UE of 4.76 points.
Severly impaired patients (FMA-UE: 0-28) improved 3.8 points, moderatley impaired patients (FMA-UE: 29-42) improved 7.99 points, mildly impaired patients (FMA-UE: 43-66) improved 5.29 points. People that achieved an average classification accuracy >80 % improved by 6.5 points, people that were below 80 % had an improvement of 2.3 points.
The following tests showed additionally a significant improvement: Bartel, Modified Ashworth Scale Wrist, Modified Ashworth Scale Fingers, Box and Block Test of Affected Hand, Box and Block Test of Healthy Hand, 9-hole PEG Test of Affected Hand, 9-hole PEG Test of Healthy Hand, Fahn Tremor Rating Scale of Affected Hand, Fahn Tremor Rating Scale of Healthy Hand, Lower Extremity Fugl Meyer Assessment, Montreal Cognitive Assessment, Stroop Color-Word Test.
Other control studies go on average an improvement of 3.92 points in FMA-UE (FES, robotic movement, visual feedback). Stephen et al. (2012) defined the clinically important difference (CID) for moderately to minimally impaired patients in chronic stroke. This CID refers to the UE-FM improvement and is 4.25 to 7.25 points. recoveriX achieved for moderately impaired patients 7.99 points which is higher than the CID. For minimally impared patients, recoveriX achieved 5.29 points which is in the range of the CID.
Furthermore, the study showed that recoveriX leads to the same improvement independent of how long ago the stroke happened (Range: 6 month to 31 years).