Effectiveness of A Game Based Rehabilitation on Sedentary Behavior and Physical Activity in Patients with Acute and Subacute Stroke A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Fibion Accelerometer data
研究概览
简要总结
Introduction
Stroke is a significant public health problem in low-middle-income countries, including India. Inpatients in acute care settings are particularly vulnerable to the adverse effects of physical inactivity, which can exacerbate post-stroke disabilities, increase the risk of stroke recurrence, and prolong hospital stays. Despite the recommendations, many stroke patients tend to lead a sedentary lifestyle, spending prolonged periods sitting down each day.
Objectives
To estimate the levels of physical activity using a thigh-worn triaxial accelerometer in patients with acute and subacute stroke and to determine the effectiveness of a game-based rehabilitation on sedentary behavior and physical activity in patients with acute and subacute stroke.
Methods
The study’s first phase involves estimating physical activity levels and sedentary behavior in patients with acute and subacute stroke. Wherein the patients will be screened at 3 different settings in India, and those meeting the eligibility criteria will undergo an assessment and be given an activity log and a thigh-worn triaxial accelerometer, which they will need to wear for 7 days or until discharge, followed by assessment and a follow-up assessment at 1-month post-discharge.
The second phase constitutes the recruitment of patients fulfilling the objective of this phase, followed by baseline assessment along with completion of activity log and accelerometer recording followed up by randomization into experimental and control groups The experimental group will receive game-based rehabilitation, and the control group will receive conventional physiotherapy for 3 weeks, with an assessment along with completion of activity log and accelerometer data recording for a minimum of 3 days at the end of the 3rd week. after this, both the groups will be given the context-specific exercise program as a home-based therapy which they will have to perform up to the final assessment at 1 month
Results
Objective assessment and estimation of PA levels and delivery of game-based rehabilitation in the early stroke care periods may minimize the secondary effects of sedentary behavior and help in planning to meet the recommended levels of PA, reducing the burden in LMICs.
Conclusion
This strategy may enhance physical activity, directly contributing to and promoting healthier lifestyles. Also, this can potentially reduce healthcare costs. The utilization of accelerometers and gaming technology for health-related purposes demonstrates the potential of technological advancements to tackle health issues and enhance the overall quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •PHASE ONE The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician.
- •Aged eighteen years and above Medically stable (with systolic blood pressure: one hundred twenty to one hundred sixty millimeters of mercury Oxygen saturation: greater than ninety-two percent Heart rate: forty to one hundred beats per minute Temperature: less than thirty-eight point five degrees Celsius) Montreal Cognitive Assessment score greater than or equal to twenty-six points Stroke severity score greater than five and less than twenty-four on the NIH Stroke Scale (NIHSS) PHASE TWO The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician.
- •Aged eighteen years and above Medically stable (with systolic blood pressure: one hundred twenty to one hundred sixty millimeters of mercury Oxygen saturation: greater than ninety-two percent Heart rate: forty to one hundred beats per minute Temperature: less than thirty-eight point five degrees Celsius) Patients with premorbid disability with a modified Rankin Scale score less than four Stroke severity score greater than five and less than twenty-four on the NIH Stroke Scale (NIHSS) The Brunnstrom voluntary control grade greater than or equal to one and less than or equal to six in the affected limb Modified Ashworth Scale score less than or equal to three in the affected limb Montreal Cognitive Assessment score greater than or equal to twenty-six points Ability to come to a propped-up position with or without support.
排除标准
- •PHASE 1 Global or receptive aphasia Severe infections and cardiopulmonary diseases Any brain-related surgical procedure Any skin problems in the area of accelerometer placement.
- •Any other musculoskeletal conditions or significant medical problems or co-morbidities Early deterioration/Premature decline Isolation regime because of infection Physician-ordered bed rest PHASE 2 Global or receptive aphasia Severe infections and cardiopulmonary diseases (acute coronary syndrome, severe heart failure) Any brain-related surgical procedure Any skin problems in the area of accelerometer placement.
- •Early deterioration/Premature decline Any other musculoskeletal conditions or significant medical problems or co-morbidities Isolation regime because of infection Physician-ordered bed rest.
结局指标
主要结局
Fibion Accelerometer data
时间窗: Phase 1 | Continuous monitoring will be performed from the time of recruitment until hospital discharge or up to 7 days, whichever occurs first. | Phase 2 | Continuous monitoring will be conducted for 3 consecutive days post-recruitment and repeated for an additional 3 consecutive days at the end of the 3-week intervention period.
次要结局
- Stroke Physical Activity Questionnaire (SPAQ)
- Motor Assessment Scale (MAS)
- 2 Minute step test (2MST)
- The National Institutes of Health Stroke Scale (NIHSS)
- Montreal Cognitive Assessment (MoCA)
- Fugl-Meyer Assessment (FMA)
- Berg Balance Scale (BBS)
- Modified Rankin Scale(mRS)
- Physical Activity in Inpatient Rehabilitation Assessment((PAIR))
研究者
S Aparna Selvam
Manipal college of Health Professions, Manipal Academy of Higher education, Manipal