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NCT Number: NCT04281394

Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity

Gait enables individuals to move forward and is considered a natural skill. However, gait disturbances are very common in patients with burn injury. Major causes of functional impairment are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT). This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.

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Key information

Conditions

Burns Gait Disorder, Sensorimotor Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

About this study

This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.

20 patients with burn were randomly divided into 2 groups. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. The conventional group underwent conventional physical therapy twice a day, 5 times a week in 12 weeks. Main outcomes were functional ambulatory category(FAC), 6 minutes walking test(6MWT), visual analogue scale(VAS), isometric forces of bilateral knee and ankle muscles, and foot pressure analysis before and after 12 weeks training.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with full or virtually full thickness involvement of >50% on the body surface area of the lower extremity
  • age > 18 years
  • with ≤1 functional ambulation category (FAC) score ≤ 3

Exclusion criteria

  • patients with cognitive disorders before burn
  • serious cardiac dysfunction
  • problems with weight bearing due to unstable fractures
  • body weight ≥100 kg
  • severe fixed contracture
  • skin disorders that could be worsened by RAGT and conventional rehabilitation
  • patients with severe pain who were unable to undergo conventional rehabilitation programs.

Treatment and study plan

Robot assisted gait training

Device

SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks.

Conventional Gait Training

Other

even level gait training and range of motion exercises

Primary outcomes

  1. the changes of functional ambulatory category

    Time frame: baseline, and after 12 weeks intervention

    Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently. Higher scores mean a better outcome.

  2. the changes of 6 minutes walking test

    Time frame: baseline, and after 12 weeks intervention

    6MWT was performed in accordance with standardized guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min. Higher scores mean a better outcome.

  3. the changes of visual analogue scale

    Time frame: baseline, and after 12 weeks intervention

    Visual analogue scale was used to rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points. higher scores mean a worse outcome

Secondary outcomes

  1. the changes of active range of motion of flexion and extension

    Time frame: baseline, and after 12 weeks intervention

    The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint)

  2. the changes of active range of motion of flexion and extension

    Time frame: baseline, and after 12 weeks intervention

    The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(knee joint)

  3. the changes of active range of motion of dorsiflexion and plantarflexion

    Time frame: baseline, and after 12 weeks intervention

    The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint)

  4. the changes of isometric forces of knee flexion and knee extension

    Time frame: baseline, and after 12 weeks intervention

    Isometric knee extension and knee flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded.

  5. the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion

    Time frame: baseline, and after 12 weeks intervention

    Isometric ankle dorsiflexion, and ankle plantar flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded.

  6. the changes of gait symmetry using stride length

    Time frame: baseline, and after 12 weeks intervention

    Stride is the equivalent of a gait cycle. The duration of a stride is the interval between two sequential initial floor contacts by the same limb. symmetry ratio is defined with affected side stride length/ non affected side stride length.

  7. the changes of center of foot pressure pattern

    Time frame: baseline, and after 12 weeks intervention

    center of foot pressure patten during a normal stride. longitudinal line analysis

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Collaborators

  • Ministry of Health, Republic of Korea

Registry information

Official study title

Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity : a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2020
Registry last updated
Feb 26, 2020

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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