A randomized, single-blind investigator exploratory clinical trial to evaluate the effects of a flexible power structure-based electric ankle orthosis on gait in chronic stroke patients with hemiplegia

Not Applicable

• Conditions: Diseases of the nervous system

• Registration Number: KCT0007993
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

? Adult patients over the age of 19
? Hemiplegic patients due to ischemic or hemorrhagic stroke
? Chronic stroke patients 6 months after stroke onset
? Patients with Functional Ambulatory Category = 3 points or higher
? A patient who understands the study, is willing to participate voluntarily, and agrees to participate
? MMSE = 10 points or patients with sufficient communication and cognitive abilities

Exclusion Criteria

? Patients with ataxia confirmed in neurological examination (cranial nerve test, cerebellar function test, balance test)
? Patients with serious musculoskeletal disorders of the lower extremities: When it is impossible to wear an electric ankle brace or to train for walking due to existing bone disease, joint disease or injury, or joint pain while walking
? Patients who show limitation of motion in the evaluation of the joint range of motion of the lower extremities
? Patients with lower extremity fractures or open trauma or unhealed ulcers
? Those who have difficulty in electric ankle orthosis gait treatment due to serious internal medical conditions such as cardiovascular disease or lung disease
? Persons with severe osteoporosis predicted to occur fractures
? Patients with other neurological diseases affecting the lower extremities (eg. Parkinson disease, multiple sclerosis, etc.)
? Patients with a Dorsiflexor and Plantarflexor Modified Ashworth Scale (MAS) score of 3 or higher of the affected ankle
? In other cases, when the researcher judges that it is inappropriate to participate in this research

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of change in m/s value of 10 Meter Walk Test (10MWT), which can measure short-distance walking speed and ability before/after 5 training sessions

Secondary Outcome Measures

Name	Time	Method
After 5 gait training 6 Minute Walk Test (6MWT);After 5 gait training Energy consumption;After 5 gait training 3D Motion Capture;After 5 gait training Usability/satisfaction evaluation