The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
270
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Hamamatsu, Shizuoka, Japan
Unnamed facility
Kumamoto, Kumamoto, Japan
Onset of shoulder hand syndrome
The incidence rate of shoulder hand syndrome
Time frame: 12 weeks
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency
MBI efficiency means MBI gain divided by period of administration
Time frame: 12 weeks
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency
FMA efficiency means FMA gain divided by period of administration
Time frame: 12 weeks
Pain score by numeric rating scale
Time frame: 12 weeks
Swelling asymmetry between hands
Time frame: 12 weeks
Discolouration of the skin of the hand
Time frame: 12 weeks
Difference in skin temperature between hands
Time frame: 12 weeks
Decreased range of motion
Time frame: 12 weeks
Radiographic finding of bone
Time frame: 12 weeks
Bone metabolic marker
Time frame: 12 weeks
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