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临床试验/NCT02779036
NCT02779036已完成不适用

The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke

Mahidol University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2016年6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
63
试验地点
2
主要终点
6 Minutes Walk Test

研究概览

简要总结

In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.

详细描述

The majority of stroke individuals unable to reenter their previous community life after they have had a stroke. Reintegration of community life by optimizing walking function is a major goal of stroke rehabilitation. Because not widely available inpatient rehabilitation, discharged with incomplete recovery, limited numbers of technically trained physical therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation setting has been interested in many developing countries.

Task- oriented exercise is well known and accepted approach to optimize walking function with underlying principles of motor control and motor learning theories. This approach has been used in the clinical setting with close supervision, but identification of appropriate protocol in the community environment is on progress. To date, no proper home exercise program based on task-oriental principle with minimal supervision for improving walking competency after stroke has been proposed in stroke rehabilitation.

The purpose of this study is to investigate the effects of a structured, progressive, task- oriented home exercise program on walking competency in individual post stroke.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI.
  • •Age between 40 to 65 years old.
  • •Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
  • •Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).
  • •Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)

排除标准

  • •Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
  • •Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
  • •Fugl Meyer Assessment score (lower extremity) less than ≤ 21
  • •Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
  • •Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

研究组 & 干预措施

Task-oriented Exercise

Experimental

Structured, progressive, task-oriented, home exercise program

干预措施: Task-oriented home exercise (Procedure)

Usual Care

Active Comparator

Usual Physiotherapy Care

干预措施: Usual Physiotherapy Care (Procedure)

结局指标

主要结局

6 Minutes Walk Test

时间窗: up to 8 weeks

Patients will be measured their walking distance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.

10 Meter Walk Test

时间窗: up to 8 weeks

Patients will be measured their walking speed by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.

次要结局

  • Dynamic Gait Index(Baseline and 8 weeks)
  • Berg Balance Scale(up to 8 weeks)
  • Stroke Impact Scale (Participation)(Baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thin Thin Moe

Ph D candidate

Mahidol University

研究点 (2)

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