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Clinical Trials in South Korea / NCT07277166
Recruiting Not applicable

The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury

NCT07277166 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2025-05-13
Last updated
2025-12-11

Condition(s) studied

BurnsGait DysfunctionRobot Training

Investigational drug(s) / intervention(s)

wearable robot training

wearable robot training: The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks.

Study summary

This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.

Eligibility

Sex
ALL
Min age
19 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. -aged over 18 years * had a Functional Ambulation Category (FAC) score of 3 or higher Exclusion Criteria: * fourth-degree burns (involving muscles, tendons, and bone injuries) * severe communication disorders because of intellectual impairment and psychological problems * Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more. * Patients with heart and circulatory conditions that may affect gait training. * Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hangang sacred heart hodpital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07277166 on ClinicalTrials.gov ↗ ← All trials in South Korea