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Идёт набор NCT06649500

Identify the Most Effective Rehabilitation Method Between a Treatment with a Sensorized Treadmill (Walker View) and a Treatment with Conventional Group Therapy in Balance Disorders and the Use of Artificial Intelligence to Identify Predictive Indices to Prevent Falls and Diagnose Promptly the Risk

Без фазы С лечением Balance Disorders Rehabilitation Falls Falls Prevention

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: Treadmill, conventional therapy.
Кому может быть актуально
Состояния в реестре: Balance Disorders, Rehabilitation, Falls, Falls Prevention. Базовые параметры: от 65 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

Comparison Between Treatment with Sensorized Treadmill and Conventional Therapy in Balance Disorders and Use of Artificial Intelligence in Identifying Predictive and Prognostic Indices of the Risk of Falling in Balance Disorders in Adult-elderly Subjects

Обзор

Falls in the elderly are one of the main sources of disability and hospitalization, with a significant impact on quality of life and social and healthcare costs. Falls represent a significant health concern for people over 60 years old. Numerous studies have shown that falls cause serious health consequences. Around 30% of people over the age of 60 experience a fall during the year. According to the impact falls have, the investigators decided to analyze the effectiveness of training on a Walker View sensorized treadmill, with the possibility of exercises for coordination and balance, compared to training with a conventional group therapy, in order to understand the best training to reduce the risk of falling and observe the possible improvements in daily life activities. So the study aims to identify the most effective rehabilitation method between a treatment with a sensorized treadmill (Walker View) and a conventional group therapy in balance disorders. The study also aims to identify predictive indices, with the use of Artificial Intelligence, that can contribute to the prevention and diagnosis of balance disorders in a short time and prevent falls in the elderly.

Вмешательства

  • Другое Treadmill
    The Walker View system is a treadmill equipped with a loaded cell sensor belt and a 3D camera that allows you to detect every single angular movement of the subject. Furthermore, thanks to the two optics, a classic one for 2D shooting in high resolution, and a revolutionary one for infrared rays, it is possible to reconstruct the position of the subject in space in three-dimensional mode and in real time. The reflected image reconstructed by the system helps to improve movement through the \&#34
  • Другое conventional therapy
    Conventional therapy intervention will follow the usual treatment according to current clinical practice. This treatment will be delivered to patients in a group session in order the balance disorders.

Первичные конечные точки

  • Change in Step Length of Gait Analysis [Срок оценки: Baseline, 6 weeks, 10 weeks]
Вторичные конечные точки (8)
  • Balance [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Mobility [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Risk of falling [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Daily Living [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Instrumental Activites of Daily Living [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Muscle strength [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Patient reported Quality of Life [Срок оценки: Baseline, 6 weeks, 10 weeks]
  • Stability [Срок оценки: Baseline, 6 weeks, 10 weeks]

Критерии участия

Критерии включения

  • Age ≥ 65 years
  • Consent to participate in the study
  • Positive history of balance disorders
  • Absence of cognitive deficits (MMSE ≥ 24)
  • Tinetti \< 25

Критерии исключения

  • Clinical pictures associated with musculoskeletal, cardiovascular, cerebrovascular, neuro-psychic problems and post-surgical outcomes that make the planned evaluation tests unfeasible.
  • Inability to carry out a walking test.
  • History of more than one fall in the last six months.
  • Subjects who have not expressed informed consent to participate in the study.

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

Италия · 1 центр
  • Policlinico Universitario Campus Bio Medico di Roma — Rome

Идентификаторы

NCT: NCT06649500 · 180.24 CET2cbm · PNC0000007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗