Telerehab Exerbrain: Bridging Physical and Cognitive Therapy in Stroke

Официальное название

Effects of Web-Based Physical-Cognitive Telerehabilitation Exergaming on Physical and Cognitive Performance in Chronic Stroke Survivors: Protocol for a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if a web-based exercise and cognitive training (physical-cognitive) program works to improve movements and brain function in adults with long-term stroke. It will also learn whether the program is safe and enjoyable. The main questions it aims to answer are: Does the program improve walking, balance, strength, and reduce fall risk? Does the program improve cognitive skills such as memory, attention, and problem-solving? Researchers will compare the online exercise-and-cognitive training program to usual care to see if the program leads to greater improvements. Participants will: * Be randomly assigned to either the online training group or the usual care group * If in the training group, complete the home-based program for 12 weeks. * Take part in physical and cognitive tests before and after the program

Подробное описание

The goal of this clinical trial is to evaluate whether a 12-week, web-based exercise and cognitive (physical-cognitive) training program can improve both physical abilities and brain function in adults with long-term stroke. The study will also examine whether the program is safe, practical to use at home, and enjoyable.

Many people who have had a stroke continue to experience problems with movement (such as walking, balance, weakness, and risk of falling) as well as problems with cognition (such as memory, attention, and problem-solving). Traditional rehabilitation often focuses mainly on physical recovery. This study tests a program that combines physical exercises and cognitive training at the same time using interactive online "exergames" delivered through telerehabilitation.

The main questions this study aims to answer are:

Does the program improve motor function, walking speed, balance, muscle power, and reduce fall risk? Does the program improve cognitive abilities, including global cognitive ability, executive function, memory, and attention? Is the program enjoyable and feasible for people with chronic stroke to use at home? In this study, 52 participants will be randomly assigned to one of two groups. One group will complete the 12-week web-based physical-cognitive training program at home. Another group will continue receiving their usual care. The researchers will compare changes in physical and cognitive performance between the two groups.

Participants in the training group will follow guided exercise sessions delivered online. All participants will complete physical and cognitive assessments before and after the 12-week period. The results of this study may help determine whether web-based physical-cognitive training is an effective and accessible rehabilitation option for people living with chronic stroke.

Вмешательства

• Поведенческое Web-Based Physical-Cognitive Telerehabilitation Exergaming
  Perform a physical-cognitive exergame via ExerbrainCMU web-based platform at home setting for 60 min/session, 3 sessions/week for 12 weeks.

Первичные конечные точки

• Executive function [Срок оценки: 3 months]
• Fall risk [Срок оценки: 3 months]
• Gait speed [Срок оценки: 3 months.]

Вторичные конечные точки (7)

• Global cognitive function [Срок оценки: 3 months]
• Attention [Срок оценки: 3 months]
• Motor function [Срок оценки: 3 months]
• Balance [Срок оценки: 3 months]
• Muscle strength [Срок оценки: 3 months]
• Weight distribution [Срок оценки: 3 months]
• Enjoyment [Срок оценки: 3 months]

Критерии участия

Критерии включения

• diagnosed with ischemic or hemorrhagic stroke at least 6 months before enrollment
• aged between 20 and 80 years
• able to walk at least 10 meters with or without assistive devices
• able to perform sit-to-stand safely with or without assistive devices
• can see the screen of a tablet or notebook computer at a distance of at least 60 cm
• have a stable medical condition and can follow study instructions
• frequent users of a mobile phone, tablet, or notebook computers

Критерии исключения

• have medical conditions or complications that would be unsafe to exercise
• have neglect, impaired communication, or uncorrected visual problems \[30\], or - have severe spasticity of the upper or lower extremities (Modified Ashworth Scale ≥ 3)

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07446062 · N42A680192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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