Stroke
Conditions
Interventions
Walking exercise using Welwalk WW-1000 for 4 weeks
Walking exercise using lower extremity orthosis only
Sponsors
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Ukai Rehabilitation Hospital Sankuro Hospital Okayama Rehabilitation Hospital Yufuin Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient who satisfied the following criteria at the pre-intervension assessment within 28 days after admission and 60 days after onset 1) Patitent who or whose proxy gave written consent to participate in the study. 2) primary supratentorial intracerebral hemorrhage or cerebral infarction 3) SIAS lower extremity total score <=6 4) SIAS vertically >=2 5) FIM-walk <=3 6) FIM-comprehension >=2 7) FIM-social interaction >=3 8) FIM-memory >=3 9) Patient whose weight is >=40 kg and <95 kg 10) Patient whose height is >=140 cm and <190 cm
Exclusion criteria
Exclusion criteria: Patient who satisfied the following criteria at the pre-intervension assessment within 28 days after admission and 60 days after onset 1) History of stroke 2) History of neuromuscular disease 3) Contracture of lower extremity disturbing walking 4) Excessive kyphosis 5) Participating other studies about function of lower extremity/trunk or walking 6) History of epileptic seizure within 2 years 7) Histroy of myocardial infarction or existence of symptomatic angina 8) Symptomatic arrhythmia 9) Uncontrollable hypertension; systemic blood pressure at rest >=180mmHg or diastolic blood pressure at rest <=120mmHg 10) Uncontrollable tachycardia; heart rate at rest >=120bpm 11) Symptomatic pulmonary disease 12) bone fragility of lower extremities or spine 13) Ectopic ossification of lower extremities causing limitation of range of motion of joints 14) Pregnancy or possibility of pregnancy 15) Patient who required isolation due to infections diseases 16) Incontinence of urine or faeces contaminating WW-1000 17) Patient who cannot don WW-1000 due to oversize, deformity and swelling of lower extremity 18) When the number of intervention patients exceed the upper limit of each hospital 19) Patient judged unsuitable by the principal investigator or Subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of independence of walking | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Functional Independence Measure (FIM) 2) Stroke Impairment Assessment Set(SIAS) 3) Walking performance 4) Gait pattern 5) Length of stay 6) Time after onset at the discharge | — |
Countries
Japan
Contacts
Public ContactSatoshi Hirano
Fujita Health University Department of Rehabilitation Medicine I, School of Medicine
Outcome results
None listed