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Идёт набор NCT06322654

A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients

Без фазы С лечением SMA

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: Robotically Assisted Locomotion, Robotically Assisted Verticalization.
Кому может быть актуально
Состояния в реестре: SMA. Базовые параметры: до 21 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
Польша
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

A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA Patients: Single-center, Randomized, Single-blinded, Comparative Study of a Robotically Active Verticalization Model Versus Robotically Assisted Locomotion Model

Обзор

A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion. The objective of research: The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models. 1. Research period: 4 years 2. Patients age: 0-21 y.o. 3. Group size: 200 patients (100 patients in each group) 4. Assignment of patients to study groups in a randomised manner

Вмешательства

  • Процедура Robotically Assisted Locomotion
    * Motor control training * Locomotion and motor control training with elements of balance and coordination * Verticalization training: standing frame device and vibration platform * Cognitive therapy
  • Процедура Robotically Assisted Verticalization
    * Motor control training * Verticalization training with Standard Frame Devices * Locomotion and motor control training with elements of balance and coordination * Cognitive therapy

Первичные конечные точки

  • Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale [Срок оценки: Through study completion, max. for 2.5 year every 6 months]
  • Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation. [Срок оценки: Through study completion, max. for 2.5 year every 6 months]
  • Functional assessment of patients using GMFM (Gross Motor Function Measure) scale [Срок оценки: Through study completion, max. for 2.5 year every 6 months]
  • X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density [Срок оценки: Once per 1 year]
  • Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0 [Срок оценки: Through study completion, max. for 2.5 year every 6 months]
Вторичные конечные точки (3)
  • Hospitalization during or between rehabilitations that take place each 6 months [Срок оценки: Through study completion, max. for 2.5 year]
  • Occurence of discomfort during therapy requiring abrupt interruption or significant modification [Срок оценки: Through study completion, max. for 2.5 year every 6 months]
  • Number of fractures [Срок оценки: Through study completion, max. for 2.5 year]

Критерии участия

Критерии включения

  • Signing of informed consent to participate in the experiment by the participant or the participant's parent/legal guardian
  • Diagnosis of SMA (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic
  • Age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth)
  • Treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility.

Критерии исключения

  • Cardio-respiratory disorders requiring invasive ventilation
  • Advanced osteoporosis with multiple fractures prior to treatment
  • Functional deterioration during the rehabilitation process in the range of scales appropriately selected for the SMA type: Prechtl, HINE, CHOP-INTEND, HFMS, RULM
  • Lack of cooperation with the therapist
  • Other functional indications preventing exercise

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
Поддерживающая терапия

Центры проведения

Польша · 1 центр
  • Wiktor Dega University Orthopedic and Rehabilitation Hospital — Poznan

Идентификаторы

NCT: NCT06322654 · 2023/ABM/01/00004/P/02

Первоисточники (государственные реестры)

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