Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy

Not Applicable

Completed

• Conditions: Bilateral Spastic Cerebral Palsy; Cerebral Palsy; Gait Disorders, Neurologic; Spastic Hemiplegic Cerebral Palsy
• Interventions: Behavioral: conventional locomotion therapy; Device: robot-assisted gait training

• Registration Number: NCT04884386
• Lead Sponsor: Sahmyook University

Brief Summary

In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Gait disorder is one of the important therapeutic goals of children with cerebral palsy, and recently robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help improve gross motor control and coordination control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-08
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-13
• Study Start: 2021-06-12
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
• Patients diagnosed with Bilateral Spastic Cerebral Palsy
• Patients diagnosed with Spastic Hemiplegic Cerebral Palsy

Exclusion Criteria

• Children who cannot understand and follow orders
• Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)> 3
• Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
• Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional locomotion therapy	conventional locomotion therapy	-
robot-assisted gait training	conventional locomotion therapy	-
robot-assisted gait training	robot-assisted gait training	-

Primary Outcome Measures

Name	Time	Method
muscle activation	Change from baseline muscle activation at 4 weeks	Measure muscle activity of Sternocleidomastoid, C4 Cervical Paraspinals, L5 Paraspinals, Rectus Femoris, Medial Hamstring, and Soleus during functional reach test. Surface electromyograph(EMG)(Mini Wave Infinity Waterproof, Cometa Systems, Italy, 2017) was used to measure muscle activity, and analysis software(Myoresearch XP Master 1.07, Noraxon, USA, 2011) was used for EMG analysis. The sampling rate was set to 2000 Hz. The EMG raw data was quantified as 150 ms after applying full wave rectification, and filtering was performed in the range of 20 to 450 Hz using a digital band-pass filter (Lancosh FIR). do

Trial Locations

Locations (1)

Ez rehabilitation medical center; 🇰🇷 Yongin-si, Korea, Republic of