Идёт набор NCT06407427

Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

Без фазы С лечением Spine Degeneration Hip Arthritis Knee Osteoarthritis Hip Fractures

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: App for in-bed conditioning exercises, Usual care.
Кому может быть актуально: Состояния в реестре: Spine Degeneration, Hip Arthritis, Knee Osteoarthritis, Hip Fractures. Базовые параметры: от 18 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 →

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Официальное название

Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients

Обзор

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

Подробное описание

The study aims to assess the effectiveness of a mobile app-based tool in improving conditioning, mobility, and physical therapy performance among patients recovering from orthopedic surgery, particularly hip fracture fixation, spinal fusion, and total knee/hip arthroplasty. The app sets reminders for in-bed conditioning exercises, with difficulty levels adjusted based on patient feedback. The prospective, single-arm pilot study will enroll patients over 65 years old with adequate cognitive status and a mobile phone. Patient performance on the app, satisfaction metrics, and physical therapy outcomes will be evaluated, along with feedback from physical therapists. The study is conducted through the Yale New Haven Health System, with plans to enroll 15 patients initially and subsequently expand to a randomized controlled trial with 50 participants in each arm. The goal is to improve outcomes in this population, characterized by poor mobility, morbidity, and mortality rates, by supplementing inpatient rehabilitation with targeted, app-prompted exercises.

Вмешательства

Устройство App for in-bed conditioning exercises
Participants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients
Другое Usual care
All participants will receive usual care in the post-operative setting.

Первичные конечные точки

Change in patient performance during physical therapy (PT) [Срок оценки: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)]

Вторичные конечные точки (7)

Patient-reported satisfaction metrics [Срок оценки: at postoperative day 3-5]
Length of stay [Срок оценки: an average of 3-5 days]
Postoperative VAS scores [Срок оценки: immediately postoperative and day of last admission, up to 5 days]
Patient performance on the app [Срок оценки: an average of 3-5 days]
Patient compliance with prescribed exercises [Срок оценки: an average of 3-5 days]
Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility [Срок оценки: up to 120 days]
Adverse Events [Срок оценки: Up to 90 Days]

Критерии участия

Критерии включения

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
English reading/speaking
Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
Must be able bodied enough to participate in a mobile app tool for physical therapy
Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Критерии исключения

Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
Severe physical impairment:

Neurologic paralysis
Polytraumas with restrictions incompatible with anti-gravity exercises
Knee immobilization, bed rest
Unstable medical conditions:

On ventilatory support
Utilizing high degrees of oxygen support (continuous BiPAP, high flow nasal cannula, nonrebreather mask, aerosol mask >3L/min)
Hemodynamic instability requiring pressor medication support (can include those on pressors for elevated mean arterial pressure goals (MAPs))
Neurologically instable with strokes, hemorrhages, increased intracranial pressures
Open wounds or surgical incisions