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Clinical Trials/NCT07277166
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 : Pilot Study

Hangang Sacred Heart Hospital1 site in 1 country20 target enrollmentStarted: May 13, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
functional ambulatory category

Overview

Brief 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.

Detailed Description

Regaining a mobility level post-surgery that comes close to the patient's previous mobility as a baseline is the goal. It is commonly accepted that conventional physiotherapy after burn injury has a positive impact on muscle strength, range of motion, pain or gait performance which all impact patient mobility. Wearable robots that assist walking centered on the hip joint of the lower extremities are appearing. This wearable robot is a positive effect in terms of increased energy efficiency and posture during walking. 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. This study excluded patients with fourth-degree burns (involving muscles, tendons, and bone injuries), severe communication disorders because of intellectual impairment and psychological problems. The specific exclusion criteria were as follows. 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.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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

functional ambulatory category

Time Frame: 12 weeks

Participants were rated on a six-point scale based on the level of physical assistance required for walking, regardless of whether an assistive device was used.

Secondary Outcomes

  • 6-Minute Walk Test (6MWT)(12weeks)
  • visual analogue scale (VAS)(12 weeks)
  • sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

So Young Joo

Principal Investigator, Department of rehabilitation medicine of Hangang Sacred heart hospial

Hangang Sacred Heart Hospital

Study Sites (1)

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