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NCT Number: NCT07578753

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

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.

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Key information

Conditions

Burn Burns Fracture Fractures, Bone Robot Assisted Gait Training Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangang Sacred Heart Hospital

Seoul, 07247, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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