cerebral disease
Conditions
Interventions
Gait training using a knee orthosis that prevent the knee bending during the stance phase using an electromagnetic braking system
Sponsors
Otaka Yohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (For non-ambulatory cases) 1. Individuals who have obtained written consent to participate in this study from the individual or his/her surrogate 2. Individuals over 18 years old 3. Individuals with gait disorder due to first-ever cerebral disease 4. Individuals scored less than 5 point in Functional Status Score for the ICU 5. Individuals scored 3 points or lower on the knee-extension test of the motor function items in Stroke Impairment Assessment Set (For ambulatory cases) 1. Individuals who have obtained written consent to participate in this study from the individual or his/her surrogate 2. Individuals over 18 years old 3. Individuals with gait disorder due to first-ever cerebral disease 4. Individuals scored 5 point or higher in Functional Status Score for the ICU 5. Individuals scored 3 points or lower on the knee-extension test of the motor function items in Stroke Impairment Assessment Set
Exclusion criteria
Exclusion criteria: 1. Individuals with uncontrolled circulatory or respiratory dysfunction 2. Individuals with infectious diseases requiring isolation or contact precautions 3. Individuals with a pacemaker device 4. Individuals with lower limb circulatory disorders contraindicating exercise 5. Individuals with ectopic ossification of the lower limbs leading to restricted joint range of motion 6. Individuals with increased fracture risk in the lower limbs or spine (e.g., severe osteoporosis) 7. Individuals with urinary or fecal incontinence severe enough to cause devise contamination 8. Individuals who are pregnant or may be pregnant 9. Individuals who have difficulty putting on the devise 10. Other patients deemed unsuitable by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (For non-ambulatory cases) Improvement efficiency of gait independence score assessed by Functional Status Score for the ICUduring intervention (For ambulatory cases) Change in gait speed assessed by 10m walk test before and after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| (For non-ambulatory cases) Gait speed measured by 10m walk test, 6-minute walking distance, gait pattern score assessed by Wisconsin Gait Scale when the individuals can walk under supervision Improvement efficiency of physical function score assessed by Stroke Impairment Assessment Set Gait independence score assessed by Functional Status Score for the ICU with and without device Device satisfaction assessed by Quality Evaluation Strategy Tool (For ambulatory cases) Changes in 6-minute walking distance, physical function score assessed by Stroke Impairment Assessment Set, and gait pattern score assessed by Wisconsin Gait Scale Walking speed assessed by 10m walk test with and without device Device satisfaction assessed by Quality Evaluation Strategy Tool | — |
Contacts
Public ContactDaisuke Imoto
Fujita Health University Hospital
Outcome results
None listed