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

NCT ID: NCT04909151

Last Updated: 2021-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-18

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy Gait Disorders, Neurologic Bilateral Spastic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Robot-assisted gait training with walking speed of 0.5km/h

Group Type EXPERIMENTAL

Robot-assisted gait training (walking speed: 0.5km/h)

Intervention Type 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.

Robot-assisted gait training with walking speed of 0.8km/h

Group Type EXPERIMENTAL

Robot-assisted gait training (walking speed: 0.8km/h)

Intervention Type 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.

Robot-assisted gait training with walking speed of 1.1km/h

Group Type EXPERIMENTAL

Robot-assisted gait training (walking speed: 1.1km/h)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahmyook University

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Joong Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sun-Geon Park, Ph.D candidate

Role: PRINCIPAL_INVESTIGATOR

The Wells Neuro Pain Clinic

Locations

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Pajucity convalescent Hospital

Paju, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sun-Geon Park, Ph.D candidate

Role: CONTACT

+82-10-6204-8377

Facility Contacts

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Sun-Geon Park

Role: primary

+82-31-942-7500

Other Identifiers

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2-1040781-A-N-012021050HR

Identifier Type: -

Identifier Source: org_study_id

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