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Идёт набор NCT07519928

Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury

Без фазы С лечением Spinal Cord Injuries (SCI)

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: Pelvic Floor Muscle Physiotherapy.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries (SCI). Базовые параметры: от 19 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical study is to determine the feasibility and explore the potential benefits of pelvic floor muscle training during inpatient SCI rehabilitation on urinary, bowel, and sexual function and quality of life in people with SCI. The main questions it aims to answer are: 1. What is the feasibility of recruiting inpatients from SCI rehabilitation to a pelvic floor muscle training program? 2. What is the feasibility and acceptance of the implementation of a pelvic floor muscle training program in SCI inpatient rehabilitation? 3. What are the potential effects of a pelvic floor muscle training program implemented in SCI inpatient rehabilitation on bladder, bowel, and sexual function and quality of life? Participants will be asked to complete a series of assessments (questionnaires, physical assessments) before and after a 6-week intervention of pelvic floor physical therapy.

Вмешательства

  • Поведенческое Pelvic Floor Muscle Physiotherapy
    Pelvic floor muscle physiotherapy 5x/week for 6-weeks.

Первичные конечные точки

  • Feasibility - Recruitment Rate [Срок оценки: Through study completion, an average of 8 months]
  • Feasibility - Compliance [Срок оценки: Through study completion, an average of 8 months]
  • Feasibility - Acceptability (Perceived Acceptability Questionnaire) [Срок оценки: Through study completion, an average of 8 months]
Вторичные конечные точки (10)
  • Incontinence Quality of Life Questionnaire (I-QoL) [Срок оценки: Through study completion, an average of 8 months]
  • Neurogenic Bladder Symptoms Score (NBSS) [Срок оценки: Through study completion, an average of 8 months]
  • Timed Bowel Routine [Срок оценки: Through study completion, an average of 8 months]
  • Neurogenic Bowel Dysfunction Score (NBDS) [Срок оценки: Through study completion, an average of 8 months]
  • International Index of Erectile Function (IIEF) Questionnaire [Срок оценки: Through study completion, an average of 8 months]
  • Female Sexual Function Index (FSFI) Questionnaire [Срок оценки: Through study completion, an average of 8 months]
  • Sexual Quality of Life Questionnaire - Male/Female (SQoL) [Срок оценки: Through study completion, an average of 8 months]
  • S4/5 Questionnaire [Срок оценки: Through study completion, an average of 8 months]
  • Pelvic Floor Electromyography [Срок оценки: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care]
  • Ultrasound Assessment [Срок оценки: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care]

Критерии участия

Критерии включения

  • Are at least 19 years of age.
  • Have a traumatic or non-traumatic SCI
  • Are able to perform a voluntary anal contraction
  • Present with bladder or urinary tract dysfunction from SCI
  • Are a current inpatient at GF Strong Rehabilitation Center and are expected to remain as an inpatient for at least 6 weeks after the time of consent.
  • Are able to speak and understand English.

Критерии исключения

  • Present with symptoms of lower motor neuron injury to the sacral segments (e.g. negative anal and bulbocavernosus reflexes)
  • Present with any other condition besides SCI that impacts the pelvic floor muscles or other pelvic structures
  • Are planning to receive intra-detrusor Botox injections in the next 3 months
  • Have a brain injury or other condition that interferes with their ability to follow instructions
  • Are using a ventilator
  • Have severe and unmanaged spasticity (involuntary muscle tightness or spasms) or contractures (prolonged muscle/joint stiffness)
  • Are unable to tolerate transfers to or lie on a physical therapy table
  • Experience severe pain that interferes with their ability to participate in pelvic floor muscle training

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

Канада · 1 центр
  • GF Strong Rehabilitation Centre — Vancouver

Идентификаторы

NCT: NCT07519928 · H26-00445

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗