The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed

Sahmyook University

Status: Unknown

Conditions: Gait Disorders, Neurologic; Cerebral Palsy; Bilateral Spastic Cerebral Palsy

Treatments: Device: Robot-assisted gait training (walking speed: 0.5km/h); Device: Robot-assisted gait training (walking speed: 1.1km/h); Device: Robot-assisted gait training (walking speed: 0.8km/h)

Study type: Interventional

Funder types: Other

Identifiers

NCT04909151

2-1040781-A-N-012021050HR

Details and patient eligibility

About

Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.

Enrollment: 39 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 4-12 years old diagnosed with cerebral palsy
• Children who have not received botulinum toxin treatment or surgery within 3 months
• Children in stage 2 of the gross motor function system
• Children who can express pain, fear, or discomfort on their own

Exclusion criteria

• Severe lower extremity contracture and fracture
• Bone instability
• Osteoporosis
• Severe bones grow disproportionately
• Unhealed skin lesions on the lower extremities (thromboembolic disease)
• Thromboembolic disease
• Cardiovascular instability
• Mild scoliosis with a Cobb's angle of more than 20 degrees

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Robot-assisted gait training with walking speed of 0.5km/h

Experimental group

Treatment:

Device: Robot-assisted gait training (walking speed: 0.5km/h)

Robot-assisted gait training with walking speed of 0.8km/h

Experimental group

Treatment:

Device: Robot-assisted gait training (walking speed: 0.8km/h)

Robot-assisted gait training with walking speed of 1.1km/h

Experimental group

Treatment:

Device: Robot-assisted gait training (walking speed: 1.1km/h)