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OpenTrials
Completed

NCT Number: NCT04884386

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ez rehabilitation medical center

Yongin-si, 16943, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

conventional locomotion therapy

Behavioral

locomotion exercise, postural control training, balance training, electrotherapy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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