Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke

Официальное название

Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke - A Feasible Study

Обзор

The goal of this clinical trial is to evaluate if the exercised via data-driven approach is effective in enhance the gait pattern in people with stroke. It will reduce burdun of patient consultations for clinicians in reality.The main questions it aims to answer are: Does individualized exercise training programmes via data-driven approach could improve gait patterns in individuals with chronic stroke? Does individualized exercise training programmes via data-driven approach could improve improve motor recovery, motor functions (including gait speed and balance performance), and community integration in individuals with chronic stroke? Participants will: Undergo 12 supervised-exercise (training sessions (60 minutes, two times a week, for six weeks), Participants will receive a data-driven exercise prescription or conventional exercise prescription which consists of 5 different exercises. They will be assessed on Baseline assessment before training (A0); after six sessions (A1); after 12 sessions (A2); and three months after training (A3).

Подробное описание

Based on the results of the gait patterns and Electromyography (EMG) analysis, the principal investigator (PI) will design appropriate exercises that target the specific gait impairment at a specific time period during the gait cycle. Exercises will utilize various modalities that are commonly used in clinical practice, including TheraBand, gym equipment, free weight. The training may target single-joint movement or targeting a movement pattern that involves multiple joint holistically. A body harness system will be used to protect the participant during the exercise training. The participant will be supervised by a research assistant who has rich experience in conducting exercise training on people with disability. Below are potential exercises that will be prescribed to the participant based on their impairment revealed by the analyses. eg. Lack of hip flexion during swing phase: Open kinetic chain strengthing exercise for hip flexor in a concentric manner...

Вмешательства

• Другое Data-driven exercise
  The result from the Statistical Parametric Mapping 1D (SPM1D) analysis will be used to identify the magnitude of deviation from normal gait patterns in reference to healthy subjects for each lower limb joint. Thereby, the targeted action and joint position can be identified. Training will focus on the specific movement where the "steepest gradients" are observed. The targeted exercises will be selected based on the five largest deviations observed during the swing or stance phase. Open-chain ex
• Поведенческое Standardized exercises
  The participants will perform dose match standardised exericse program.

Первичные конечные точки

• Gait kinematics [Срок оценки: At baseline and 6 weeks post-intervention]

Вторичные конечные точки (8)

• Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait [Срок оценки: At baseline and 6 weeks post-intervention]
• Fugl-Meyer assessment (FMA-LE) [Срок оценки: At baseline and 6 weeks post-intervention]
• Berg Balance Scale (BBS) [Срок оценки: At baseline and 6 weeks post-intervention]
• Subjective Index of physical and Social Outcome (SIPSO) [Срок оценки: At baseline and 6 weeks post-intervention]
• Short Physical Performance Battery (SPPB) [Срок оценки: At baseline and 6 weeks post-intervention]
• Trunk Impairment Scale (TIS) [Срок оценки: At baseline and 6 weeks post-intervention]
• Ability to Perform Locomotion Activities (ABILOCO) [Срок оценки: At baseline and 6 weeks post-intervention]
• Timed Up and Go (TUG) test [Срок оценки: At baseline and 6 weeks post-intervention]

Критерии участия

Критерии включения

• between 45 and 75 years old;
• have received a diagnosis of stroke more than six months earlier;
• able to walk 10 m independently;
• able to score at least 6 of 10 on the Abbreviated Mental Test;
• able to follow instructions and give informed consent.

Критерии исключения

• any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
• unable to offer consent due to impaired cognitive function.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• the Hong Kong Polytechnic University — Hksar

Идентификаторы

NCT: NCT06878677 · HSEARS20240216001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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