Effects of additional, dynamic supported standing practice on functional recovery in patients with sub-acute stroke: a randomized pilot and feasibility trial.

OBJECTIVE To evaluate the feasibility and preliminary effectiveness of additional dynamic versus static passive standing performed by patients with sub-acute stroke supervised by trained helpers. DESIGN Assessor blinded, randomized pilot and feasibility trial. SETTING Neurological rehabilitation centre. PARTICIPANTS Non-ambulatory participants in the sub-acute phase after stroke. INTERVENTION Usual care plus additional standing training, consisting of either dynamic standing practice in a modified standing frame (intervention group, n=14) or static standing practice in a conventional standing frame (control group, n=14) for 5 weeks. MAIN MEASURES Feasibility was assessed through occurrence of adverse events, patient satisfaction and operability of the technical device handled by trained helpers. Preliminary effectiveness was assessed with the Berg Balance Scale (primary outcome) and other measures of physical functioning. RESULTS Trained helpers were capable to apply the intervention, and no adverse events occurred. Both groups were comparable at baseline. Within-group changes tended to be higher for the intervention group, but did not reach a significant level except for the Functional Ambulation Categories. Specifically, median pre-post improvements in the Berg Balance Scale tended to be higher in the dynamic (20, inter quartile range (IQR): 2-33 points) than in the static standing group (4.5, IQR: 0-16 points; U=62; P=0.052; effect size=0.478). CONCLUSIONS In severely affected individuals after stroke, dynamic supported standing practice can be performed safely by trained helpers. In a larger-scale phase III study, a total of 116 patients would be needed to prove the preliminary effectiveness found in this study.