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

NCT07277166 | Recruiting DMC

• 1 other identifier: HangangSHH-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Gait Dysfunction; Robot Training

Keywords

BURNS, Gait dysfunction, Wearable robot, Robot training

Outcome Measures

Primary Outcomes (1)

• functional ambulatory category

  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.

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Wearable robot training

EXPERIMENTAL

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.

Other: wearable robot training

Interventions

wearable robot training OTHER

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.

Wearable robot training

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang sacred heart hodpital

Seoul, 07247, South Korea

RECRUITING

Related Publications (2)

• Shin JH, Byeon N, Yu H, Lee D, Lee HJ, Lee WH. Effect of wearable robot Bot Fit's hip joint-centered assist torque and voice coach on walking. BMC Musculoskelet Disord. 2024 Dec 23;25(1):1063. doi: 10.1186/s12891-024-08181-8.

  PMID: 39716173 RESULT

• Cho E, Hwang S, Heo SJ, Lim B, Lee J, Lee Y. Feasibility and Effects of a Gait Assistance and Gait Resistance Training Program Using a Walking-Assist Wearable Robot for Community-Dwelling Older Adults: Single-Group, Pre-, and Posttest Study. JMIR Mhealth Uhealth. 2025 May 26;13:e58142. doi: 10.2196/58142.

  PMID: 40418849 RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

SO YOUNG JOO

CONTACT

82-10-3234-9839; anyany98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of rehabilitation medicine of Hangang Sacred heart hospial

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 11, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

KR (1)