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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy

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

Intervention / Treatment
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* Device: Robot-assisted gait training (walking speed: 0.5km/h)
* Device: Robot-assisted gait training (walking speed: 0.8km/h)
* Device: Robot-assisted gait training (walking speed: 1.1km/h)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted gait training with walking speed of 0.5km/h<br> | Device: Robot-assisted gait training (walking speed: 0.5km/h)<br>* Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.<br>|
| Experimental: Robot-assisted gait training with walking speed of 0.8km/h<br> | Device: Robot-assisted gait training (walking speed: 0.8km/h)<br>* Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.<br>|
| Experimental: Robot-assisted gait training with walking speed of 1.1km/h<br> | Device: Robot-assisted gait training (walking speed: 1.1km/h)<br>* Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait ability | Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed. | Change from baseline gait ability at 6 weeks |