The Effect of gait training using wearable robot in children with cerebral palsy
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0006273
- Lead Sponsor
- Chungnam National University Hospital
- Brief Summary
Question: Is robot-assisted gait training (RAGT) with wearable exoskeletal robots more effective than conventional physical therapy (PT) in children with CP (cerebral palsy)? Findings: Our multicenter, randomized controlled trial offers robust insights into the benefits of overground RAGT using an untethered torque-assisted wearable exoskeletal robot in children with CP. Our findings indicate significant improvements in gross motor function, gait asymmetry, and participation in daily living among the intervention group. Meaning: An untethered torque-assisted wearable exoskeletal robot, based on assist-as-needed control, is effective in children with CP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Among patients who visited the Department of Rehabilitation Medicine up to 24 months after IRB approval
? Patients who have been diagnosed with spastic cerebral palsy for more than 1 year
? Children from 6 years old ~ under 18 years old
? Children with spastic cerebral palsy with GMFCS level II to IV
? Children who can wear walking assistance robot
? Children who have the cognitive function to carry out instructions
? When the person or care-giver has been informed of the study and consented to participate in the study
? Subjects with intellectual disabilities unable to perform simple instructions during gait training and assessment
? In the case of school-age children, if there is no intention to participate even with parental consent
? Cerebral palsy with dyskinetic or ataxic type
? Excessive lower extremity spasticity of grade 3 or higher on the Modified Ashworth Scale
? In the case of lower extremity botulinum toxin injection or lower extremity casting within 3 months from the first assessment date
? In the case of lower extremities orthopedic surgery within 6 months from the first assessment date
? In the case of skin abnormality or joint contracture that restrics wearing of the wearable gait robot
? Those who have been judged by the researcher as unsuitable for this research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GMFM: Gross motor function measure
- Secondary Outcome Measures
Name Time Method PBS: Pediatric balance scale;SCALE:Selective Control Assessment of theLower Extremity ;Pediatric Evaluation of Disability Inventory(PEDI)-CAT; 10MWT:10-meter walking test ;computer based 3D motion analysis;Body composition analysis ;Rate of Perceived Exertion:Borg scale ;Oxygen consumption;adverse event;User Satisfaction and safety survey