Меню
Идёт набор NCT06176833

Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

Без фазы С лечением Spinal Cord Injuries

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: Body Weight Supported Treadmill Training.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries. Базовые параметры: 16 лет — 75 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training

Обзор

The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy. The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.

Вмешательства

  • Процедура Body Weight Supported Treadmill Training
    For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.

Первичные конечные точки

  • 10 Meter walk test [Срок оценки: 1-5 days Following Intervention]
Вторичные конечные точки (4)
  • 6 Minute Walk test [Срок оценки: 1-5 days Following Intervention]
  • Walking Index for spinal cord injury [Срок оценки: 1-5 days following intervention]
  • Daily step counts [Срок оценки: 2 weeks following 3-, 6-, 9-, and 12- month assessments]
  • Gait Deviation idex [Срок оценки: Baseline, 3-, 6-, 9-, and 12- month assessments]

Критерии участия

Критерии включения

  • History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
  • Between the ages of 16-74
  • Weight bearing as tolerated in bilateral lower extremities
  • Able to tolerate a harness
  • Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
  • Able to provide informed consent within 60 days of injury onset
  • Able to participate in all study related activities, including 1-year follow up

Критерии исключения

  • Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
  • A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
  • Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
  • Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
  • Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation
  • Pregnancy, as confirmed by blood draw

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • The Shirley Ryan AbilityLab — Chicago
  • Baylor Scott and White Institute for Rehabilitation — Fort Worth

Публикации

  • Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186/s12883-024-03980-x. PMID 39702102

Идентификаторы

NCT: NCT06176833 · STU00219541 · CDMRP- SC220241

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗