Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Fugl-Meyer
研究概览
简要总结
m-CIMT therapy is the restriction of the unaffected upper extremity in conjunction with an upper extremity specific exercise protocol to improve the functionality and use of the affected upper extremity.
详细描述
The study consists of a total of 7 days with a total of 3 hours per day of restraint of the unaffected upper limb together with 1 physiotherapy session per day specific to the affected upper limb.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischaemic stroke.
- •Hospitalised patient (first 15 days).
- •Ability to understand and execute simple instructions.
- •Over 18 years of age.
- •Upper limb motor deficit.
- •Sign the informed consent document.
排除标准
- •Unstable clinical/medical condition.
- •Limitation of the upper limb due to a previous stroke.
- •Strokes affecting both upper limbs bilaterally.
- •Fractures/dislocations in the joints of the affected upper limb that may affect recovery.
- •Severe behavioural disturbance.
结局指标
主要结局
Fugl-Meyer
时间窗: Basal, immediately after the intervention, 3 months after treatment
The Fugl-Meyer Upper Extremity Scale assesses motor function of the arm and hand after stroke. It measures movements, reflexes and coordination, with a maximum score of 66. It is a structure-measuring tool. This scale is scored from 0 to 66 with 66 being the best score.
Abilhand
时间窗: Basal, immediately after the intervention, 3 months after treatment
The ABILHAND assesses a person's ability to perform manual activities of daily living. It is based on the patient's perception of the difficulty of these tasks. It is a tool for measuring activity. This scale is scored from 0 to 46 with 46 being the best score.
Motor Activity Log
时间窗: 3 months after treatment
The Motor Activity Log (MAL) assesses how much and how well a person uses their affected arm in everyday activities after a stroke. It is based on interviews and rates the Amount of Use and Quality of Movement of the use of the paretic arm in daily life. This scale has two scores, quality and quantity. From 0 to 150 for quantity and from 0 to 150 for quality. 150 being the best result in both cases.
Fatigue Assessment Scale (FAS)
时间窗: Basal, immediately after the intervention, 3 months after treatment
The Fatigue Assessment Scale (FAS) is a questionnaire that assesses the level of physical and mental fatigue in patients with various health conditions. It consists of 10 items that the patient answers according to their recent experience. This scale has two scores: Mental fatigue from 0 to 25 (sum of items 3, 6, 7, 8 and 9) and physical fatigue from 0 to 25 (sum of items 1, 2, 4, 5 and 10). With 25 being the worst score for both cases.
Stroke Impact Scale
时间窗: Basal,immediately after the intervention, 3 months after treatment
The Stroke Impact Scale (SIS) assesses the difficulty a person has in performing daily activities during the last two weeks after a stroke. The minimum score on this scale is 16 points and the maximum is 80 points, with 80 being the best score.
次要结局
- Modified Rankin Scale (MRS)(Basal, immediately after the intervention, 3 months after treatment)
- National Institutes of Health Stroke Scale (NIHSS)(Basal, immediately after the intervention, 3 months after treatment)