The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed

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

The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy

Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

39

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 Contact

Study Locations

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 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 4-12 years old diagnosed with cerebral palsy
  • Children who have not received botulinum toxin treatment or surgery within 3 months
  • Children in stage 2 of the gross motor function system
  • Children who can express pain, fear, or discomfort on their own

Exclusion Criteria:

  • Severe lower extremity contracture and fracture
  • Bone instability
  • Osteoporosis
  • Severe bones grow disproportionately
  • Unhealed skin lesions on the lower extremities (thromboembolic disease)
  • Thromboembolic disease
  • Cardiovascular instability
  • Mild scoliosis with a Cobb's angle of more than 20 degrees

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 with walking speed of 0.5km/h
Device: Robot-assisted gait training (walking speed: 0.5km/h)
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.
Experimental: Robot-assisted gait training with walking speed of 0.8km/h
Device: Robot-assisted gait training (walking speed: 0.8km/h)
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.
Experimental: Robot-assisted gait training with walking speed of 1.1km/h
Device: Robot-assisted gait training (walking speed: 1.1km/h)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait ability
Time Frame: Change from baseline gait ability at 6 weeks
Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.
Change from baseline gait ability at 6 weeks

Collaborators and Investigators

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

Sponsor

Sahmyook University

Investigators

  • Principal Investigator: Sun-Geon Park, Ph.D candidate, The Wells Neuro Pain Clinic

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 18, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-1040781-A-N-012021050HR

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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