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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007993
Enrollment
20
Registered
2022-12-12
Start date
2023-01-02
Completion date
Unknown
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : - training ? Training is divided into two sessions: 5 Exo_on training sessions with power assistance from an electric ankle brace, and 5 Exo_off training sessions without power assist

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactChang Jun Ko

Yonsei University Health System, Severance Hospital

koko1032@yuhs.ac+82-2-2228-8340

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026