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

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: Cerebral Palsy; Gait Disorders, Neurologic; Bilateral Spastic Cerebral Palsy
• Intervention / Treatment: Device: Robot-assisted gait training (walking speed: 0.5km/h); Device: Robot-assisted gait training (walking speed: 0.8km/h); Device: Robot-assisted gait training (walking speed: 1.1km/h)

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sun-Geon Park, Ph.D candidate; Phone Number: +82-10-6204-8377; Email: spring1056@naver.com

Study Locations

• Korea, Republic of
  • Paju, Korea, Republic of, 10915
    • Recruiting
    • Pajucity convalescent Hospital
    • Contact: Sun-Geon Park; Phone Number: +82-31-942-7500; Email: spring1056@naver.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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

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

Study record dates

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: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Nervous System Diseases; Paralysis; Gait Disorders, Neurologic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• 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