Stroke
Conditions
Brief summary
Endpoints: Safety and tolerability variables ● Incidence of SAEs and AESIs. ● Incidence of AEs. ● Physical examination, laboratory tests, ECG, and vital signs (temperature, blood pressure, and heart rate). ● Scales that assess spasticity (MAS), spasm (PSFS) and pain (VAS). ● Clinical scales for anxiety and depression (BDI-II and HADS). ● Number of falls and % of standing activity. ● Self-perceived mood., Efficacy variables Primary endpoint: ● Six-minute walking test (6MWT).
Detailed description
Efficacy variables:Secondary endpoints: ● Borg CR10 Scale (post 6MWT). ● Gait speed via Ten-Meter Walk Test (10MWT). ● Fatigue Severity Scale (FSS). ● Multidimensional Fatigue Inventory (MFI-20). ● Stroke Impact Scale (SIS 3.0). ● Patient Global Impression of Change (PGIC). ● Health-related quality of life via EQ-5D-5L questionnaire.
Interventions
Sponsors
Sinfatin S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints: Safety and tolerability variables ● Incidence of SAEs and AESIs. ● Incidence of AEs. ● Physical examination, laboratory tests, ECG, and vital signs (temperature, blood pressure, and heart rate). ● Scales that assess spasticity (MAS), spasm (PSFS) and pain (VAS). ● Clinical scales for anxiety and depression (BDI-II and HADS). ● Number of falls and % of standing activity. ● Self-perceived mood., Efficacy variables Primary endpoint: ● Six-minute walking test (6MWT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy variables:Secondary endpoints: ● Borg CR10 Scale (post 6MWT). ● Gait speed via Ten-Meter Walk Test (10MWT). ● Fatigue Severity Scale (FSS). ● Multidimensional Fatigue Inventory (MFI-20). ● Stroke Impact Scale (SIS 3.0). ● Patient Global Impression of Change (PGIC). ● Health-related quality of life via EQ-5D-5L questionnaire. | — |
Outcome results
None listed