To evaluate the safety and potential efficacy of "recombinant human growth hormone (rhGH)" on the functional recovery of completed stroke patients.
Completed stroke patients were recruited. All participants were randomly assigned to the GH group (rhGH injection and rehabilitative therapy) or the control group (only rehabilitative therapy). Above all, they were closely monitored for safety. Further, for the efficacy measurement, Korean Modified Barthel Index (K-MBI), Manual Muscle strength Test (MMT), and Fugl-Meyer assessment (FMA) were assessed to determine the changes of functional recovery during 6-months of the study period. Along with it, diffusion tensor image was taken as the baseline, and a followed-up study to observe the changes in diffusion tensor tractography (DTT), during the period, and one patient in the GH group was also examined with functional MRI (fMRI). Index of fatigue on 5 point scale for the study period was also assessed.
Twenty-two patients were enrolled, and 15 completed the study and were included in the analysis. No harmful adverse events were observed in the GH group. By comparison between the groups, the GH group showed more improvement in K-MBI than the control group (p<0.05). DTT showed less decrement of fibers in the GH group than in the control group, without statistical significance. fMRI showed an increment in the activated area. Patients in the GH group expressed no fatigue at all, during the study period (p=0.00).
The administration of rhGH in long term resulted in the improvement in K-MBI, and subjectively less tiredness during the injection period.
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