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临床试验/NCT01693341
NCT01693341已完成不适用

Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Asia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Stroke Impact Scale

研究概览

简要总结

To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.

详细描述

In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •>6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
  • •No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)

排除标准

  • •Recurring strokes
  • •Mental or cognitive impairment
  • •Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
  • •Caregiver with mental/behavioral disorders

研究组 & 干预措施

Care-giver mediated training

Active Comparator

Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need.

干预措施: Care-giver mediated training (Other)

Standard-care

No Intervention

Maintain the inherent standard-care

结局指标

主要结局

Stroke Impact Scale

时间窗: Baseline and 12 weeks

Change from baseline in Stroke Impact Scale at 12 weeks

次要结局

  • 10-meter walking speed(Baseline and 12 weeks)
  • Lawton Instrumental Activities of Daily Living scale (IADL)(Baseline and 12 weeks)
  • Berg balance scale(Baseline and 12 weeks)
  • 6-min walking distance(Baseline and 12 weeks)
  • Bathel index score(Baseline and 12 weeks)
  • Fugl-Meyer Assessment Scale(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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