Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study

NCT07578753 | Enrolling By Invitation

• 1 other identifier: HangangSHH-23
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures. In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training.

Conditions

Burn; Fracture; Robot Assisted Gait Training

Keywords

Burn; Fracture; Robot assisted gait training

Outcome Measures

Primary Outcomes (1)

• functional ambulatory category

  Ambulatory ability was assessed using the FAC scale. 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.

  8 weeks

Secondary Outcomes (4)

• manual muscle test, MMT

  8 weeks

• active range of motion (AROM) of the lower limbs

  8 weeks

• pain score (visual analog scale, VAS)

  8 weeks

• 6-minute walking test (6 MWT)

  8 weeks

Study Arms (1)

robot assited gait training

OTHER

All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.

Other: robot assisted gait training

Interventions

robot assisted gait training OTHER

All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.

robot assited gait training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 19 years or older
• admitted to the Department of Rehabilitation Medicine after the wound had epithelialized following wound treatment via skin grafting or aseptic dressing procedures
• underwent fixation or brace treatment after a lower limb fracture was diagnosed via imaging at the time of injury
• sufficient cognitive function to follow the therapist's instructions during training
• a functional ambulatory category (FAC) of 1 or higher and 3 or lower.

You may not qualify if:

• unable to bear weight owing to fracture union failure or complications such as osteomyelitis
• severe pain rendering the patient unable to wear the robotic device
• scars that may bleed or become infected when wearing the robotic device
• a history of lower limb weakness or reduced gait ability due to other causes prior to injury
• lower limb sensory disturbances caused by peripheral neuropathic diseases such as diabetes
• height less than 120 cm or body mass more than 120 kg
• withdrawal of consent.

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, 07247, South Korea

Location

Related Publications (2)

• Franks PW, Bryan GM, Martin RM, Reyes R, Lakmazaheri AC, Collins SH. Comparing optimized exoskeleton assistance of the hip, knee, and ankle in single and multi-joint configurations. Wearable Technol. 2021 Nov 24;2:e16. doi: 10.1017/wtc.2021.14. eCollection 2021.

  PMID: 38486633 RESULT

• Iziumov A, Hussein TS, Kosenko E, Nazarov A. Adaptive Exoskeleton Device for Stress Reduction in the Ankle Joint Orthosis. Sensors (Basel). 2025 Jan 30;25(3):832. doi: 10.3390/s25030832.

  PMID: 39943472 RESULT

MeSH Terms

Conditions

Burns; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome measurements and data analyses were conducted by trained, blinded assessors who were not involved in the training.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RAGT and conventional gait training were performed by a physical therapist with more than 7 years of experience with patients with burns. Complications in the scar area and worsening of pain were monitored during gait training. All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KR (1)