The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR
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: Smart ring assisted physiotherapeutic intervention.
- Кому может быть актуально
- Состояния в реестре: Osteo Arthritis Knee. Базовые параметры: 18 лет — 70 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
- Финляндия
- 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
The Effect of Smart Ring Assisted Physiotherapeutic Intervention on the Risk of Poor Outcome 12 Months After a Total Knee Replacement: a Randomized Controlled Trial
Обзор
The goal of this randomized controlled trial is to learn about the effect of a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor patient reported outcome after a primary total knee replacement. The main question it aims to answer is whether a wearable activity tracker assisted physiotherapeutic intervention and remote monitoring may help to decrease the number of the poor patient reported post-operative outcome 12 months after a primary total knee replacement. Participants will receive standard postoperative care which includes physiotherapy appointments 4 weeks and 3 months after the surgery and they will use smart rings (Oura ring) 3 months postoperatively. Patients will be remotely monitored to follow their recovery from total knee replacement surgery: the study group physiotherapists will follow the patients' activity and sleep and if necessary, make a contact with patient if there seems to low activity indicating difficulties with recovering from the surgery. Researchers will compare the intervention group to a group of participants who will receive only standard postoperative care with physiotherapy appointments 4 weeks and 3 months, to see if the use of the Oura ring may decrease the number of participants with poor patient reported post-operative outcome after total knee replacement.
Вмешательства
- Другое Smart ring assisted physiotherapeutic intervention
the effect of a smart ring (Oura), a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor outcome measured on patient reported post-operative outcome (Oxford Knee Score) 12 months after a primary total knee replacement.
Первичные конечные точки
- the proportion of patients with poor postoperative outcome [Срок оценки: 12 months after total knee replacement surgery]
Вторичные конечные точки (12)
- homogeneity of variance in the Oxford Knee Score [Срок оценки: 12 months after the surgery]
- Oxford Knee Score [Срок оценки: 3 months after the surgery]
- Oxford Knee Score [Срок оценки: 6 months after the surgery]
- Oxford Knee Score [Срок оценки: 12 months after the surgery]
- EQ-5D-5L [Срок оценки: 3 months after the surgery]
- EQ-5D-5L [Срок оценки: 6 months after the surgery]
- EQ-5D-5L [Срок оценки: 12 months after the surgery]
- Forgotten Joint Score 12 (FJS-12) [Срок оценки: 3 months after the surgery]
- Forgotten Joint Score 12 (FJS-12) [Срок оценки: 6 months after the surgery]
- Forgotten Joint Score 12 (FJS-12) [Срок оценки: 12 months after the surgery]
- pain at rest using the visual analoque (VAS scale) [Срок оценки: 3 months after surgery]
- pain at rest using the visual analoque (VAS scale) [Срок оценки: 6 months after surgery]
Критерии участия
Критерии включения
- Patients undergoing primary TKA for primary osteoarthritis.
- Patients able to consent and willing to comply with the study protocol.
- Patients aged 18 to 70 years
- Patients is able to use a smartphone and a smart ring.
Критерии исключения
- Patients unwilling to provide informed consent
- >15 degrees varus or valgus, or > 15 degrees fixed flexion deformity
- Physical, emotional, or neurological conditions that would compromise the patient, e.g., poor compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions, such as Parkinson, MS, etc.)
- Patients unable to attend the study physiotherapy appointments at the outpatient clinic.
- Patients unable to wear Oura ring (example in case of OA or rheumatoid arthritis in the finger joints).
- Patients with cardiac arrhythmia.
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Финляндия · 1 центр
- Coxa Hospital for Joint Replacement — Tampere
Публикации
- Hautala J, Koriseva L, Reito A, Mattila V, Eskelinen A. Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial. BMJ Open. 2025 May 15;15(5):e091956. doi: 10.1136/bmjopen-2024-091956. PMID 40379331
Идентификаторы
NCT: NCT05599776 · R22078