The Effects of the Control Strategies of Wearable Lower Limb Rehabilitation Robots

Официальное название

Effects of Control Strategies in Wearable Lower Limb Rehabilitation Robots

Обзор

Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.

Вмешательства

• Устройство Robot-assisted overground gait training
  Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers).

Первичные конечные точки

• Change in 10 Meter Walk Test from baseline gait speed [Срок оценки: Baseline, immediately after intervention]

Вторичные конечные точки (1)

• Change scores of Lower Extremity Fugl-Meyer Assessment (FMA-LE) [Срок оценки: Baseline, immediately after intervention]

Критерии участия

Критерии включения

Stroke patients aged between 18 and 75 years. Patients who are medically stable and able to stand and walk independently for at least 10 meters during rehabilitation.

Stroke event occurred at least 3 months ago Patients with impaired lower limb motor function but with some degree of muscle activity in the lower extremities.

Patients without severe cognitive impairment and capable of understanding and following the treatment protocol.

Patients without severe balance or coordination disorders, able to maintain balance and perform gait training with assistive devices.

Patients without lower limb fractures or other serious skeletal issues affecting the lower limbs.

Patients without severe cardiovascular or other serious illnesses and able to tolerate the intensity and duration of rehabilitation therapy.

Patients willing to participate in the study and able to provide written informed consent.

Критерии исключения

Severe cognitive impairment that prevents the patient from understanding or complying with the treatment protocol.

Severe balance or coordination disorders that prevent the patient from maintaining balance and participating in gait training, even with assistive devices.

Other serious motor disorders, such as abnormal muscle tone or ataxia, which may interfere with the effectiveness of rehabilitation therapy.

Active cardiovascular disease or other serious systemic illnesses that may affect the patient's safety or treatment outcomes.

Lower limb fractures or other serious skeletal issues that may impact the suitability and safety of robot-assisted rehabilitation therapy.

Patients currently receiving other rehabilitation or experimental treatments. Patients with skin ulcers, infections, or other severe skin conditions that may interfere with the use and application of robotic devices.

Unexplained discomfort or pain symptoms that may limit the patient's ability to participate in rehabilitation therapy.

Failure to meet other specific inclusion criteria outlined in the study protocol.

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

Китай · 1 центр

• Eight affiliated hospital, Sun Yat-Sen University — Шэньчжэнь

Идентификаторы

NCT: NCT07037849 · 202421602 · U21A20136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗