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

November 18, 2021 updated by: Hyun-Joong Kim, Sahmyook University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Yongin-si, Korea, Republic of, 16943
        • Ez rehabilitation medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: robot-assisted gait training
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
Active Comparator: conventional locomotion therapy
Behavioral: conventional locomotion therapy
locomotion exercise, postural control training, balance training, electrotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline muscle activation at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahmyook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

May 8, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-1040781-A-N-012021048HR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

I plan to decide after the study is over.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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