Effect of Overground Gait Training using a Torque-Assisted Exoskeletal Wearable Device on Ambulatory Function in Subacute Stroke Patients, Multi-Center, Randomized Single-blinded Controlled Prospective Pilot Study
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 150
? patients with significant difficulty in communication, such as severe cognitive impairment (MMSE <10) or speech-language impairment
? patients with ataxia
? patients with spasticity of the affected lower extremity of measured by Modified Ashworth scale (Modified Ashworth Scale (MAS) = 2)
? patients with severe musculoskeletal disorder in the lower limbs
? patients with a contracture that limits the lower limb range of motion
? patents with apparent leg length discrepancy of 2 cm or more (Rt: cm / Lt: cm)
? patients with a lower limb fracture or open wound or unhealed ulcer
? patients to whom robot-assisted gait rehabilitation cannot be applied due to a severe cardiovascular or pulmonary disease
? patients with a history of osteoporotic fracture
? patients with a neurological disorder that may affect the ambulatory function (e.g. Parkinson disease, multiple sclerosis, etc.)
? patients determined to be ineligible by the investigator
? patients who express a desire to drop out of treatment
? patients who do not comply with the guidelines provided by the investigator
? patients who require a treatment outside the scope of the present clinical study
? patients who show a severe injury due to an accident such as a fall
? patients who participate in < 80% of training sessions
? patients who show a new major condition and consequently require absolute rest for recovery
(e.g. another incidence of stroke, aggravation of stroke, myocardial infarction, any other neurological, internal, or musculoskeletal condition, etc.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Ambulatory Category (FAC)
- Secondary Outcome Measures
Name Time Method Fugl Meyer Assessment-Lower Extermity;10 Meter Walking Test (10MWT);6 Minute Walking Test;Physiological cost index;Berg Balance Score (BBS);Trunk Control Test (TCT);Functional Independence Measure (FIM);Modified Ashworth Scale;Motricity index-Lower Extremity;Geriatric depression scale-short form (GDS-SF)