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

May 5, 2026 updated by: Hangang Sacred Heart Hospital

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Background : 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.

Material and Methods: 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. To evaluate clinical efficacy, functional ambulation category (FAC), muscle strength (manual muscle test, MMT), active range of motion (AROM) of the lower limbs, 6-minute walking test (6 MWT), pain score, gait kinematics, and spatiotemporal gait parameters will be measured before and after 8 weeks training.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 07247
        • Hangang Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: robot assited 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.
Other: robot assisted 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional ambulatory category
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
manual muscle test, MMT
Time Frame: 8 weeks
. Lower limb muscle strength was assessed using the MMT based on the Medical Research Council scale for muscle strength.
8 weeks
active range of motion (AROM) of the lower limbs
Time Frame: 8 weeks
Full AROM of the hip, knee, and ankle joints was measured before and after training.
8 weeks
pain score (visual analog scale, VAS)
Time Frame: 8 weeks
A visual analog scale (VAS) was used to rate the degree of subjective pain during gait movement (0 points: no pain, 10 points: unbearable pain).
8 weeks
6-minute walking test (6 MWT)
Time Frame: 8 weeks
The 6 MWT was conducted according to standardized guidelines on a 20-m walking course. Patients were instructed to walk as far as possible within 6 min.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangang Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HangangSHH-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to disclose it upon a legitimate request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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