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Набор по приглашению NCT07578753

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

Без фазы С лечением Burn Fracture Robot Assisted Gait Training

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: robot assisted gait training.
Кому может быть актуально
Состояния в реестре: Burn, Fracture, Robot Assisted Gait Training. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • functional ambulatory category [Срок оценки: 8 weeks]
Вторичные конечные точки (4)
  • manual muscle test, MMT [Срок оценки: 8 weeks]
  • active range of motion (AROM) of the lower limbs [Срок оценки: 8 weeks]
  • pain score (visual analog scale, VAS) [Срок оценки: 8 weeks]
  • 6-minute walking test (6 MWT) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Hangang Sacred Heart Hospital — Seoul

Публикации

  • 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
  • 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

Идентификаторы

NCT: NCT07578753 · HangangSHH-23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗