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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909151
• Other study ID #: 2-1040781-A-N-012021050HR
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: June 2021
• Source: Sahmyook University
• Contact: Sun-Geon Park, Ph.D candidate
• Phone: +82-10-6204-8377
• Email: spring1056[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders, Neurologic
• Nervous System Diseases
• Paralysis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Pajucity convalescent Hospital	Paju

Sponsors (1)

Lead Sponsor	Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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