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Clinical Trials/NCT04884386
NCT04884386CompletedNot Applicable

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

Sahmyook University1 site in 1 country22 target enrollmentStarted: June 12, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
muscle activation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

robot-assisted gait training

Experimental

Intervention: robot-assisted gait training (Device)

robot-assisted gait training

Experimental

Intervention: conventional locomotion therapy (Behavioral)

conventional locomotion therapy

Active Comparator

Intervention: conventional locomotion therapy (Behavioral)

Outcomes

Primary Outcomes

muscle activation

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyun-Joong Kim

collaborator

Sahmyook University

Study Sites (1)

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