Идёт набор NCT06612359

Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke

Фаза I С лечением Stroke with Hemiparesis Stroke

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: BOOST GAIT Program.
Кому может быть актуально: Состояния в реестре: Stroke with Hemiparesis, Stroke. Базовые параметры: от 18 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: Бельгия
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

Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke - a Pilot Study Impact Van Het BOOST GAIT Programma Op Het Herstel Van Het Gangbeeld En Functionele Mobiliteit Na Een Beroerte - Een Pilootstudie

Обзор

The overarching goal is to determine if the BOOST GAIT program can improve functional mobility in patients with stroke who are undergoing inpatient rehabilitation and have some walking function, through the application of augmented therapeutic exercises designed to achieve a normative gait pattern. The evaluation will be conducted using a combination of clinical scales and objective motion sensors that map walking quality and performance during activities of daily living, such as rising from a chair and standing. It is acknowledged that this single-group pilot study, which aims to include 12 participants, is insufficiently powered to address the primary objective. A larger parallel-design study is required to definitively address this issue. To help design a larger study, the current objectives are: first, to have realistic expectations regarding recruitment and dropout rates; second, to identify potential barriers to therapy adherence and data collection that may impede the success of a larger study; third, assess the test-retest reliability of sensor-based motion capture of movement quality during walking and related tasks in hemiparetic stroke patients. For the latter objective, the sensor measurements at the end of the intervention will be repeated on two consecutive days. In addition to their usual care, participants will undergo additional therapy over a four-week period, with sessions occurring five times per week for one hour as part of the BOOST GAIT program. The BOOST GAIT sessions will be conducted as group-based therapy with four patients and two physiotherapists present to oversee the performance of mobility-specific exercises, including sit-to-stand transfers, standing and stepping, and eventually walking. The rationale for this approach is that the combined effects of augmenting the amount of therapeutic exercises and specifically targeting motor control of the paretic leg will facilitate symmetry during tasks, which in turn will have carry-over effects on safe performance of walking and other mobility tasks.

Вмешательства

Поведенческое BOOST GAIT Program
In addition to usual care, participants will undergo additional therapy over a four-week period, with sessions occurring five times per week for one hour. The BOOST GAIT sessions will be conducted as group-based therapy with four patients and two physiotherapists present to oversee the performance of mobility-specific exercises, including sit-to-stand transfers, standing and stepping, and eventually walking.

Первичные конечные точки

Self-selected Gait Speed (m/s) [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]

Вторичные конечные точки (8)

Fugl-Meyer assessment - motor subscale for the Lower Extremity (FM-LE) [0-34] [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Motricity Index - subscale for the Lower Extremity (MI-LE) [0-100] [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Berg Balance Scale (BBS) [0-56] [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Functional Ambulation Category (FAC) [0-5] [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Smoothness during a sit-to-stand transfer [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Postural sway during quiet standing [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Spatio-temporal parameters of the gait pattern during self-selected walking over a short distance [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]
Spatio-temporal parameters of the gait pattern during fastest walking over a longer distance [Срок оценки: At inclusion and the end of the intervention at 4 weeks.]

Критерии участия

Критерии включения

A first-ever unilateral stroke, infarction or bleeding
Undergoing inpatient rehabilitation in the Jessa hospital, Herk-de-Stad
Less than 3 months after stroke onset at the moment of inclusion
18 years of older
Berg Balance Scale score 24 or higher (out of 56) at moment of inclusion
Timed Up-and-Go score 14 s or higher at moment of inclusion
Functional Ambulation Category 3 or higher at moment of inclusion
Understanding the goals and procedures of this study and giving informed consent