Stroke Rehabilitation System of Oriental and Western Medicine Based on Three-level Network Rehabilitation Model Under the Background of Medical Alliance in Huzhou
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fugl-Meyer motor score
研究概览
简要总结
The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement.
Researchers randomly assigned 90 patients to either group A or Group B, 45 in each group. Group A adopted the conventional three-level rehabilitation model; Group B adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of Chinese and Western medicine. Fugl-Meyer motor score was used to assess the patient's motor ability, Berg balance scale was used to assess the patient's balance ability, National Institute of Health stroke scale was used to assess the patient's neurological function, and modified Barthel index was used to assess the patient's ability of daily living.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose primary disease is stroke, whose diagnosis conforms to the "Chinese and Western Medicine Emergency Diagnosis and Treatment Expert Consensus for Acute Ischemic Stroke";
- •confirmed by imaging MRI or CT;
- •hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop.
排除标准
- •Patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past;
- •patients with lumbar spine or sacral spinal stenosis in the past;
- •patients with previous epilepsy;
- •patients with previous history of stroke;
- •patients with heart and renal failure;
- •Patients who cannot cooperate with treatment.
结局指标
主要结局
Fugl-Meyer motor score
时间窗: Assessment was made after 3 months of intervention
This scale evaluates the patient's motor ability, including 7 major items and 17 sub-items such as reflex activity, cooperative movement, coordination ability, speed, etc. each item is 0-2 points, a total of 34 points, the higher the score, the better the exercise ability.
The Berg balance scale
时间窗: Assessment was made after 3 months of intervention
This scale evaluate the balance ability of the patients, and the balance ability of the two groups of patients before and after 6 months of treatment was scored, including standing, sitting, standing-to-sit transfer, bed-chair transfer, and turning around, totaling 14 items, totaling 56 score (the higher the score, the better the balance ability)
National Institute of Health stroke scale
时间窗: Assessment was made after 3 months of intervention
This scale evaluate the neurological function of the two groups before treatment and 4 weeks after treatment, including consciousness, eye movement, visual field, facial paralysis, limb movement, limb coordination, sensation, vision, hearing and touch, totaling 11 items, totaling 42 points (the higher the score, the more serious the neurological deficit of the patient).
Barthel index
时间窗: Assessment was made after 3 months of intervention
This scale evaluate the daily living ability of the two groups of patients before treatment and 4 weeks after treatment, including eating, bathing, grooming, dressing, control of urination, toileting, and seat transfer.10 items such as walking and going up and down stairs, each item is scored from 0 to 10,with a total of 100 points (the higher the score, the stronger the patient's daily living ability).
次要结局
未报告次要终点
研究者
Wenming Feng
President
The First People's Hospital of Huzhou