Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke - A Feasible Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Gait kinematics
研究概览
简要总结
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).
详细描述
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...
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
- •unable to offer consent due to impaired cognitive function.
结局指标
主要结局
Gait kinematics
时间窗: At baseline and 6 weeks post-intervention
Seventeen wearable sensors (Inertial Measurement Units, IMUs) were attached to the participants' bodies in accordance with the Xsens user manual to collect kinematic data. The extracted data included the pelvis tilt angle (°), oblique angle (°), and rotation angle (°); hip flexion angle (°) and abduction angle (°); knee bending angle (°); as well as ankle flexion angle (°) and abduction angle (°), which were used for further analysis. These data were converted into standardized gait cycles (101 time points) for statistical parametric mapping (SPM1D) analysis, and the deviation time from the normal reference was compared to determine whether there were changes in deviation timing before and after the treatment.
次要结局
- Fugl-Meyer assessment (FMA-LE)(At baseline and 6 weeks post-intervention)
- Berg Balance Scale (BBS)(At baseline and 6 weeks post-intervention)
- Subjective Index of physical and Social Outcome (SIPSO)(At baseline and 6 weeks post-intervention)
- Short Physical Performance Battery (SPPB)(At baseline and 6 weeks post-intervention)
- Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait(At baseline and 6 weeks post-intervention)
- Trunk Impairment Scale (TIS)(At baseline and 6 weeks post-intervention)
- Ability to Perform Locomotion Activities (ABILOCO)(At baseline and 6 weeks post-intervention)
- Timed Up and Go (TUG) test(At baseline and 6 weeks post-intervention)
研究者
Dr Patrick Kwong
Assistant Professor
The Hong Kong Polytechnic University