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

Cerebral Palsy Clinical Trial

Official title:

Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Bilateral Spastic and Hemiplegic Cerebral Palsy: A Single-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884386
• Other study ID #: 2-1040781-A-N-012021048HR
• Status: Completed
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Sahmyook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders, Neurologic
• Muscle Spasticity
• Nervous System Diseases
• Paralysis
• Spastic Hemiplegic Cerebral Palsy

Intervention

Device:
• 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.

Behavioral:
• conventional locomotion therapy
locomotion exercise, postural control training, balance training, electrotherapy

Locations

Country	Name	City	State
Korea, Republic of	Ez rehabilitation medical center	Yongin-si

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	muscle activation	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	Change from baseline muscle activation at 4 weeks