Stroke Stroke
Conditions
Interventions
Rehabilitation therapy combining robot-assisted walking training using WellWalk and conventional physical therapy using lower limb orthoses (orthotic gait training), or rehabilitation therapy using or
Sponsors
Otaka Yohei
Hirano Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients whose consent to participate in this study has been obtained in writing from the individual or his/her surrogate 2. patients whose age is between 16 and 90 years old 3. patients with hemiplegia due to first-ever supratentorial cerebral infarction or cerebral hemorrhage 4. patients with 6 or less points in the total score of the Stroke Impairment Asssessment Set lower limb motor items at the pre-intervention evaluation 5. patients with 1 or less points in Functional Ambulation Category at the pre-intervention evaluation. 6. patients with 4 points on the E item and 6 points on the M item in the Glasgow Coma Scale at the pre-intervention evaluation. 7. patients who weigh more than 35 kg and less than 100 kg 8. patients with height between 140 cm and 190 cm
Exclusion criteria
Exclusion criteria: 1. patients with a history of stroke, excluding patients who had no symptoms of previous stroke despite imaging findings that indicated a history of stroke. 2. patients who had gait disorder before stroke due to neuromuscular or locomotor diseases. 3 patients who have participated in other intervention studies on motor function of lower limb and trunk and gait 4 patients with a history of epileptic seizures within 2 years, including seizures caused by the current stroke 5.patients with cardiovascular or respiratory disease that makes exercise therapy difficult 6. patients with uncontrolled hypertension 7. patients with severe osteoporosis of the lower limbs or spine. 8. patients with heterotopic ossification of the lower extremity leading to joint range of motion limitation 9. patients who are pregnant or may become pregnant 10. patients with infectious diseases which require isolation 11. patients with urinary or fecal incontinence to the point of welwalk contamination 12. patients who are unable to wear the robotic leg due to oversized or deformed lower limbs or pressure ulcers 13. other patients who are deemed inappropriate by the attending physician, principal investigator, or research assistants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who reached Functional Ambulation Category (FAC) 3 within 8 weeks, the maximum intervention period, and the time required to reach it | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Outcomes before intervention: age, gender, height, weight, disease type, number of days from onset to start of treatment, Glasgow Coma Scale (GCS) items E and M, Stroke Impairment Assessment Set (SIAS) lower limb motor, sensory, and trunk functions, muscle strength on the nonparalytic side, visuospatial Cognition, FAC, Functional Independence Measure (FIM) total score 2. Outcomes of End of intervention: FAC, percentage of FAC 3 or higher, number of weeks required to reach FAC 3, SIAS lower extremity motor and trunk function, speed, overlapping steps, and walking rate on the 10-m walk test, 6-minute walk distance, number of steps during practice during the intervention period 3. Changes over time in SIAS lower limb motor and trunk functions before intervention, at 4 weeks, 8 weeks, and at discharge 4. Outcomes at discharge: FAC, SIAS lower limb motor and trunk function, speed, overlapping steps, and walking rate by 10-m walk test, 6-minute walk distance, FIM total, number of days from onset to discharge, adverse events, concomitant medications, and concomitant therapies 5. Case enrollment rate, recruitment rate, adherence rate, retention rate | — |
Contacts
Public ContactSatoshi Hirano
Fujita Health University Hospital
Outcome results
None listed