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

NCT04884386 | Completed

• 1 other identifier: 2-1040781-A-N-012021048HR
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy; Bilateral Spastic Cerebral Palsy; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

robot-assisted gait training

EXPERIMENTAL

Device: robot-assisted gait training; Behavioral: conventional locomotion therapy

conventional locomotion therapy

ACTIVE COMPARATOR

Behavioral: conventional locomotion therapy

Interventions

robot-assisted gait training DEVICE

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

conventional locomotion therapy BEHAVIORAL

locomotion exercise, postural control training, balance training, electrotherapy

conventional locomotion therapy; robot-assisted gait training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Ez rehabilitation medical center

Yongin-si, 16943, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: collaborator

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: June 12, 2021
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

KR (1)