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Идёт набор NCT07550647

Early Rehabilitation After Total Hip Arthroplasty

Без фазы С лечением Total Hip Arthroplasty (THA)

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: Early Postoperative Physiotherapy, Neuromuscular Electrical Stimulation (NMES), Telerehabilitation, Standard Postoperative Care.
Кому может быть актуально
Состояния в реестре: Total Hip Arthroplasty (THA). Базовые параметры: 50 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Early Rehabilitation on Functional Recovery After Total Hip Arthroplasty: A Randomized Controlled Trial

Обзор

This study aims to investigate the effects of an early postoperative rehabilitation program combined with neuromuscular electrical stimulation (NMES) and telerehabilitation on functional recovery in patients undergoing total hip arthroplasty (THA). In the early postoperative period, patients commonly experience muscle weakness, impaired gait, and functional limitations that may delay recovery. Early rehabilitation has been shown to improve functional outcomes, while NMES may enhance muscle activation, particularly in hip abductor muscles. Additionally, telerehabilitation may support continuity of care following discharge by enabling supervised home-based exercise. In this prospective study, participants will be assigned to either an intervention group receiving early physiotherapy combined with NMES and telerehabilitation, or a control group receiving standard postoperative care. Functional outcomes, gait parameters, quality of life, and muscle-related changes will be evaluated at predefined time points.

Подробное описание

This study is designed as a prospective, randomized controlled clinical trial to evaluate the effectiveness of an early postoperative rehabilitation program combined with neuromuscular electrical stimulation (NMES) and telerehabilitation in patients undergoing total hip arthroplasty (THA).

Following THA, patients frequently experience muscle weakness, gait asymmetries, and reduced functional capacity, which may prolong recovery. Although early mobilization and rehabilitation are widely recommended, the combined effects of NMES and telerehabilitation within a structured early-phase rehabilitation program have not been sufficiently investigated.

Participants will be randomly allocated into intervention and control groups using a simple randomization method. The intervention group will receive a structured physiotherapy program initiated on the first postoperative day and continued daily during hospitalization. This program will be combined with NMES targeting the gluteus medius muscle, applied using surface electrodes placed over the motor point with stimulation parameters adjusted according to patient tolerance.

After discharge, participants in the intervention group will continue a structured home-based exercise program supported by synchronous telerehabilitation sessions conducted three times per week. These sessions will enable real-time supervision, feedback on exercise performance, and progression based on standardized tolerance criteria.

The control group will receive the standard postoperative care protocol routinely applied in the clinic, without additional NMES or telerehabilitation support.

All participants will be evaluated at predefined time points: preoperatively (within 3 days before surgery), at discharge (postoperative day 6), and at postoperative week 4. Outcome assessments will be performed by an experienced physiotherapist blinded to group allocation, and intervention delivery and outcome assessment will be conducted by different physiotherapists.

The primary objective of the study is to determine whether the addition of NMES and telerehabilitation to early rehabilitation improves functional recovery following THA. Secondary objectives include evaluating changes in muscle strength, joint mobility, pain levels, gait characteristics, and muscle morphology.

Вмешательства

  • Другое Early Postoperative Physiotherapy
    A structured physiotherapy program including mobilization and therapeutic exercises initiated on postoperative day 1 and continued daily until discharge (5 days).
  • Устройство Neuromuscular Electrical Stimulation (NMES)
    NMES applied to the gluteus medius muscle starting on postoperative day 1, administered daily for 5 days using standard stimulation parameters to enhance muscle activation.
  • Другое Telerehabilitation
    A 3-week home-based exercise program supported by synchronous video-based telerehabilitation sessions conducted three times per week after discharge.
  • Другое Standard Postoperative Care
    Routine postoperative care including wound monitoring and general medical follow-up during hospitalization. At discharge, patients receive a home exercise brochure without supervised rehabilitation or telerehabilitation.

Первичные конечные точки

  • Timed Up and Go (TUG) Test [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4.]
  • 10-Meter Walk Test (10MWT) [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Stair Climb Test [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
Вторичные конечные точки (9)
  • 6-Minute Walk Test (6MWT) [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Hip Muscle Strength (Manual Muscle Testing) [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Range of Motion (ROM) [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Pain Intensity (Visual Analog Scale - VAS) [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Hip Function and Quality of Life (International Hip Outcome Tool-12) [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Gluteus Medius Muscle Sarcopenia (CT-Based Assessment) [Срок оценки: Preoperative (within 3 days before surgery) and postoperative week 4]
  • Step Length [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Cadence [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]
  • Walking Speed [Срок оценки: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4]

Критерии участия

Критерии включения

  • Patients scheduled for unilateral total hip arthroplasty due to osteoarthritis or developmental dysplasia of the hip (DDH)
  • Aged between 50 and 75 years
  • Willing and able to participate in all follow-up assessments
  • Able to comply with assessment procedures
  • Able to meet the requirements of telerehabilitation
  • Undergoing surgery with a standardized surgical protocol

Критерии исключения

  • Previous history of total hip arthroplasty on either side
  • Planned revision total hip arthroplasty
  • Severe osteoarthritis in the contralateral hip
  • Presence of severe acute metabolic, neuromuscular, or cardiovascular disease
  • History of active malignancy
  • Presence of respiratory infection
  • Concomitant orthopedic conditions (e.g., lower extremity fractures, severe hip/knee deformities, lumbar or sacroiliac dysfunction)
  • Body mass index >35
  • Occurrence of postoperative complications (e.g., prosthetic infection, thromboembolic events, or conditions requiring reoperation)

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
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Niğde Ömer Halisdemir University, Education and Research Hospital — Niğde

Публикации

  • Baldwin ER, Klakowicz PM, Collins DF. Wide-pulse-width, high-frequency neuromuscular stimulation: implications for functional electrical stimulation. J Appl Physiol (1985). 2006 Jul;101(1):228-40. doi: 10.1152/japplphysiol.00871.2005. Epub 2006 Apr 20. PMID 16627680
  • Marchisio AE, Ribeiro TA, Umpierres CSA, GalvAo L, Rosito R, Macedo CAS, Galia CR. Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial. Rev Col Bras Cir. 2020;47:e20202548. doi: 10.1590/0100-6991e-20202548. Epub 2020 Aug 12. English, Portuguese. PMID 32844909
  • Madara KC, Marmon A, Aljehani M, Hunter-Giordano A, Zeni J Jr, Raisis L. PROGRESSIVE REHABILITATION AFTER TOTAL HIP ARTHROPLASTY: A PILOT AND FEASIBILITY STUDY. Int J Sports Phys Ther. 2019 Jul;14(4):564-581. PMID 31440408
  • Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237. PMID 23190932

Идентификаторы

NCT: NCT07550647 · CD2

Первоисточники (государственные реестры)

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