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

Not Applicable

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

• Registration Number: NCT04909151
• Lead Sponsor: Sahmyook University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Status Verified: 2021-06
• Study First Posted: 2021-06-01
• Study Start: 2021-06-18
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21
• Primary Completion: 2021-09-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait ability	Change from baseline gait ability at 6 weeks	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.

Trial Locations

Locations (1)

Pajucity convalescent Hospital; 🇰🇷 Paju, Korea, Republic of