Severe Upper Limb Hemiplegia
Conditions
Brief summary
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.
Interventions
DRUGHC-58
once or more / week
DRUGPlacebo
once or more / week
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with severe upper limb hemiplegia after stroke * Within 28 days after stroke at enrollment
Exclusion criteria
* Patients with sensory loss between shoulder and hand on paralyzed side * Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of shoulder hand syndrome | 12 weeks | The incidence rate of shoulder hand syndrome |
| Change from Baseline in the modified Barthel index (MBI) and MBI efficiency | 12 weeks | MBI efficiency means MBI gain divided by period of administration |
| Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency | 12 weeks | FMA efficiency means FMA gain divided by period of administration |
Secondary
| Measure | Time frame |
|---|---|
| Difference in skin temperature between hands | 12 weeks |
| Decreased range of motion | 12 weeks |
| Pain score by numeric rating scale | 12 weeks |
| Bone metabolic marker | 12 weeks |
| Radiographic finding of bone | 12 weeks |
| Swelling asymmetry between hands | 12 weeks |
| Discolouration of the skin of the hand | 12 weeks |
Countries
Japan
Outcome results
None listed