A Translational Study of Clinical Effects of Gait Rehabilitation Robots in Children with Gait Disorders

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007557

Enrollment

Registered

2022-07-26

Start date

2022-08-04

Completion date

Unknown

Last updated

2022-10-24

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 : 1) Experimental Group A -Walking training based on angle control treadmill using Walkbot-K((P&S Mechanics, Korea) - 3 times per week, 30 minutes per session, total of 6 weeks 2) Expe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Among patients who visited the Department of Rehabilitation Medicine up to 36 months after IRB approval ? Patients with gait disorders caused by cerebral palsy or in-progressive brain injury for more than 6 months ? 5 years of age or older~ 18 years of age or younger ? Corresponds to levels 2 to 4 of the Great Motor Function Classification System (GMFCS) (level II to IV) ? Simple instruction performance is subject to the degree of cognitive function possible ? Where the person or guardian has heard the explanation of the study and agreed to participate in the study; ? Height of 115 cm or more for two robots to wear

Exclusion criteria

Exclusion criteria: ? Subjects with intellectual disabilities to the extent that it is impossible to perform instructions during gait training and evaluation ? In case of severe joint contracture (contraction of more than 20 degrees of flexion in the knee joint, and more than 40 degrees of flexion of the hip joint) ? In case of severe lower extremity stiffness grade 3 or higher on the Modified Ashworth Scale on the lower extremity stiffness scale ? If you have experience with lower extremity botulinum toxin treatment or lower extremity plaster fixation within 3 months from the first evaluation date ? In case of orthopedic surgery on the lower extremities within 6 months from the first evaluation date ? Other subjects deemed unsuitable for this study by the tester

Design outcomes

Primary

Measure	Time frame
GMFM:Gross motor function measure	—

Secondary

Measure	Time frame
PBS:Pediatricbalancescale;10MWT:10-meterwalkingtest;Gillette FAQ ;Edinburgh Visual Gait Score;functional near-infrared spectroscopy;Photoplethysmography;User Satisfaction and safety survey;adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactJayoung Choi

Chungnam National University Hospital

cielewme@naver.com+82-42-338-2418

Outcome results