Cerebral palsy, spina bifida, cerebrovascular disorder, and cerebrospinal cord injury
Conditions
Interventions
Patient receive exercise therapy with HAL lower limb type 2S size for 20 minutes once a day, and 8 to 12 times during the study period.
Sponsors
Marushima Aiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are eligible for this study enrollment. 1) Patients who can give written consent by their substitute. 2) Patients aged 5-15 years. 3) Patients with Level 2-4 of GMFCS (Gross Motor Function Classification System). 4) Patients more than 1 year after onset. 5) Patients who can wear HAL lower limb type 2S size prototype and its improved equipment. (The height is assumed to be 100-150cm, but the usage condition is not for height but for patients who fit the body size such as thigh length, lower leg length, waist width) 6) Patients who can continue hospitalization or go outpatient according to the study schedule during the study period.
Exclusion criteria
Exclusion criteria: Patients who conflict with one of the following criteria are excluded and not subject to this clinical study. 1) Patients who have difficulty performing voluntary limb movements according to instructions due to impaired consciousness or severe Intellectual disability. 2) Patients whose skeletal system such as osteoarthritis, spondyloarthropathy, scoliosis, etc. is severely deformed and difficult to train including joint movement or wear HAL. 3) Patients who have complications such as bleeding tendency or osteoporosis which may cause training problems. 4) Patients who cannot be put on the electrode on the skin surface due to a skin disease etc. 5) Patients who participated in other studies within 12 weeks of the start of this clinical study. 6) Patients who are considered inappropriate to participate in this study by the principal investigator or member doctors of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 88 items of gross motor function measure (GMFM-88) | — |
Secondary
| Measure | Time frame |
|---|---|
| The 66 items of gross motor function measure (GMFM-66) Gross motor function classification system Maximal walking speed, step length, cadence 2 min walking distance 6 min walking distance Gait posture, motion analysis (muscle activity) Canadian Occupational Performance Measure (COPM) Questionnaire for patients and families Disease occurrence status Test equipment failure | — |
Contacts
Public ContactAiki Marushima
University of Tsukuba Hospital
Outcome results
None listed