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Идёт набор NCT06162052

Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery

Без фазы С лечением Burns

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: Tele-Rehabilitation.
Кому может быть актуально
Состояния в реестре: Burns. Базовые параметры: 18 лет — 79 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 →

Обзор

The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.

Подробное описание

This is a prospective single center randomized trial comparing a traditional approach to physical therapy to a technology-enhanced approach following a burn. We hypothesize that with the implementation of a novel telerehabilitation program incorporating technology enhancement, range of motion and quality of life can be improved. To test the hypothesis in future grant applications, this pilot study will be used to determine feasibility, collect preliminary data, vet endpoints, and gain patient feedback. To achieve these necessary goals, we will compare two methods of supporting home performance of prescribed physical and occupational therapy: Standard (S): patients will be equipped with paper instructions for their physical therapy exercises; and Technology-Enhanced (TE) support: patients will be given paper instructions, set up with a habit and productivity application (Avocation) that gamifies tasks and tracks achievements, a Fitbit activity tracker, a logbook, and have virtual movement therapy once weekly with an exercise physiologist for a total of four weeks.

Specific Aim 1: To determine whether range of motion is altered with TE. Range of motion in the affected joint(s) will be measured by goniometry (self-reported by patient and measured by study staff in the clinic)

Specific Aim 2: To determine whether TE with prescribed movement affects scar, pain, and quality of life.

Вмешательства

  • Другое Tele-Rehabilitation
    Technology will be used to enhance rehabilitation.

Первичные конечные точки

  • Change in range of motion, measured with a goniometer [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]
Вторичные конечные точки (8)
  • Scar Volume [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]
  • Elasticity, color, temperature, trans epidermal water loss, and scar thickness [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]
  • Blood Flow [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]
  • Patient and Observer Scar Assessment Scale v2.0 [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]
  • Pain Visual Analog Scale (VAS) Score [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]
  • Post Interview [Срок оценки: 6 months (± 2 weeks) post discharge]
  • Overall Activity [Срок оценки: Months 2, 4, and 5 (+15 days, each timepoint) in addition to 1, 3, & 6 months after discharge.]
  • Itch Scale [Срок оценки: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)]

Критерии участия

Критерии включения

  • Adults: ≥18 to ≤79 years of age
  • Not participating in another interventional trial
  • Admitted to the Blocker Burn Unit for treatment of initial burn
  • Subject is able and willing to follow the protocol requirements
  • Burn wound / scar / contracture occurring across at least one joint.
  • Has regular access to smart phone, tablet, or computer with internet access.

Критерии исключения

  • Any medical condition that, in the opinion of the investigator or physician, would place the subject at increased risk for participation.
  • Concurrent participation on another interventional clinical trial
  • History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
  • Patients without internet access.

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 · 1 центр
  • University of Texas Medical Branch — Galveston

Идентификаторы

NCT: NCT06162052 · 21-0331

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗