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Идёт набор NCT06908564

Balance Rehabilitation Based on Serious Games

Без фазы С лечением Hip Replacement, Total

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: Experimental: Interactive balance rehabilitation based on serious games., Active Comparator: conventional balance rehabilitation without the use of technological devices..
Кому может быть актуально
Состояния в реестре: Hip Replacement, Total. Базовые параметры: 18 лет — 85 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
Италия
Следующий шаг
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Официальное название

Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study

Обзор

The effects of new technologies, particularly exergames, on the rehabilitation process of patients with hip arthroplasty have not yet been verified. For this reason, the aim of this study is to evaluate the effectiveness, in terms of balance recovery, of a balance rehabilitation program based on serious games in individuals with hip arthroplasty compared to conventional treatment.

Подробное описание

Total Hip Arthroplasty (THA) is one of the most commonly performed orthopedic surgeries worldwide, primarily aimed at reducing pain, improving function, and enhancing quality of life. Over the past decade, the rate of THA has increased by 30%, and it is projected to double by 2035. Rehabilitation after THA includes pain management, wound care, self-care, motor therapy, early mobilization, and complication prevention \[iv, v, vi\]. Active patient involvement in the rehabilitation process is increasingly recognized as essential for improving post-THA autonomy .

Exergames can enhance patient engagement and attention during treatment, potentially leading to better rehabilitation outcomes. The application of game design approaches in rehabilitation has gained popularity, offering more engaging treatments that boost patient motivation and understanding. Serious games, which are not primarily intended for entertainment, focus on specific therapeutic goals. In motor rehabilitation, exergames allow patients to perform physical exercises through video game interaction, often integrating sensors and biosensors that provide biofeedback and enable therapists to monitor progress and personalize treatment.

Despite their growing popularity, there is limited literature on the effectiveness and safety of exergames in orthopedic rehabilitation. A systematic review by Wang et al. found a moderate reduction in pain with technology-assisted rehabilitation (via tele-rehabilitation) in patients with hip and knee arthroplasty, but no significant effects on functional mobility. Research specifically on THA patients is scarce and of low quality. Byra et al. reported similar findings, indicating a lack of comprehensive evidence on the effectiveness of technological rehabilitation in THA patients, although preliminary results in pain management, posture training, and proprioception are promising.

The effects of new technologies, particularly exergames, on the rehabilitation of patients with hip arthroplasty remain unverified. This study aims to evaluate the effectiveness of a balance rehabilitation program based on serious games in individuals with hip arthroplasty compared to conventional treatment.

Вмешательства

  • Устройство Experimental: Interactive balance rehabilitation based on serious games.
    The intervention of the Experimental Group consists of 30 minutes (16 sessions, 4 days/week, for 4 weeks) of balance rehabilitation exercises using non-immersive virtual reality through the OAK device (Khymeia Group, Italy). The system includes exercises that require the patient to reach visual targets by shifting their Center of Pressure (COP). The exercises are categorized based on the direction of COP displacement and can be performed with increasing difficulty, as determined by the physiothe
  • Другое Active Comparator: conventional balance rehabilitation without the use of technological devices.
    Intervention of the Control Group (CG) consists of 30 minutes (4 days/week, for 4 weeks) of conventional balance rehabilitation treatments without the use of technological devices. The motor exercises will focus on the rehabilitation of balance, the trunk, and the lower limbs and will be carried out with a physiotherapist who will tailor the treatment according to the patient's characteristics and needs. Primary attention will be given to recovering trunk control and seated posture. This phase w

Первичные конечные точки

  • Time Up and Go Test (TUG) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
Вторичные конечные точки (8)
  • Cognitive Time Up and Go Test (TUG-C) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
  • Passive Range of Motion (p-ROM) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
  • Ten Meter Walking Test (10MWT) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
  • Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR). [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
  • Medical Research Council Scale (MRC) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
  • Modified Barthel Index (mBI) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
  • Visual Analog Scale (VAS) [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 months after treatment).]
  • Activities-specific Balance Confidence scale (ABC). [Срок оценки: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 Months after treatment).]

Критерии участия

Критерии включения

  • Age over 18 years;
  • First elective hip arthroplasty;
  • Cognitive ability to understand and perform the exercises outlined in the protocol;
  • Ability to sign the informed consent.

Критерии исключения

  • Unable to adhere to the exercise program due to poor compliance;
  • Previous contralateral hip arthroplasty;
  • Surgical wound complications;
  • Severe cognitive, linguistic, or visual impairments (inability to understand and follow the study procedures);
  • Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons;
  • Diagnosis of epilepsy;
  • Presence of implanted cardiac pacemakers;
  • Lack of signed informed consent for the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Италия · 2 центра
  • IRCCS San Raffaele Roma — Rome
  • Casa di Cura San Raffaele Sulmona — Sulmona

Идентификаторы

NCT: NCT06908564 · RP 23/08

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗