stroke
Conditions
Interventions
Intervention group Standing and walking exercises while wearing a Knee-ankle-foot orthosis, to be started within 10 days of onset and performed for at least 20 minutes per day Continue for up to 14
if discharged before then, the program ends on the date of discharge
Control group Standard,usual physiotherapy Standing and walking exercises while wearing a Knee-ankle-foot orthosis are permitt
Sponsors
Sapporo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cerebral infarction or hemorrhage, excluding TIA and aSAH Aged 18 years or older, but under 90 years Hospitalization within 48 hours of symptom onset mRS score of 0 to 2 prior to symptom onset Condition stabilized within 9 days of onset, allowing for standing exercises FAC0 to 1, less than BRS of lower limb5 at the time of enrollment Regardless of whether thrombolytic therapy or thrombectomy was performed
Exclusion criteria
Exclusion criteria: Patients with obesity, BMI of 35 or higher Patients unable to cooperate with exercises due to severe impaired consciousness or higher brain dysfunction Patients with severe ataxia that significantly impairs exercise performance Patients with musculoskeletal problems in the lower limbs or trunk that significantly impair exercise performance Patients with a history of fragility fractures in the lower limbs or trunk Patients with severe medical conditions that impair exercise performance Palliative care has been selected Unable to cooperate with exercises Consent for study participation not obtained within 9 days of admission Using assistive devices, robotics intended to stabilize the knee joint Individuals deemed by the physical therapist to be capable of standing and walking exercises without a Knee-ankle-foot orthosis Not eligible for Knee-ankle-foot orthosis wearing, due to weight, physique, skeletal structures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent standing or walking during physiotherapy Initiating and maintaining Knee-ankle-foot orthosis use for 20 minutes or longer Dropout rate Interruption rate Presence of adverse events during physiotherapy (hypotension, falls, fractures, pain, orthotic-related skin injuries, worsening musculoskeletal symptoms, worsening neurological symptoms, respiratory or circulatory abnormalities) Adverse events during hospitalization (worsening neurological symptoms, recurrence, hydrocephalus, pneumonia, urinary tract infection, other infections, epileptic seizures, pressure ulcers, deep vein thrombosis, cardiovascular events (heart failure, myocardial infarction, etc.), hemorrhagic events (cerebral hemorrhage, gastrointestinal bleeding, etc.)) Presence or absence of major adverse cardiovascular events (MACE: recurrent stroke, myocardial infarction, heart failure) | — |
Secondary
| Measure | Time frame |
|---|---|
| Motricity Index FAC Trunk control Test Berg balance Scale FSS-ICU Barthel Index mRS FIM-Motor All outcomes are assessed in 14days from admission | — |
Countries
Japan
Contacts
Public ContactEiji Kobayashi
Sapporo medical university School of medicine, Department of anatomy, Division of functional morphology
Outcome results
None listed