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临床试验/NCT03194282
NCT03194282已完成不适用

Effects of the Insole on Balance Capacity in Chronic Stroke

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年7月27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
32
试验地点
1
主要终点
Change in Timed Up and Go (TUG) Test from pre to post-intervention.

研究概览

简要总结

Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift body weight or to with stand external pertubations. Postural movement patterns include three discrete control strategies: hip, knee, and ankle strategy. The ankle rocker is an important factor to maintain balance during standing and the ankle strategy restores the center of mass (CoM) to a position of stability through body movement. As a result, effective control of foot motion and ankle stability may decrease postural sway and the risk of fall in chronic stroke.The purpose of this study is to investigate the effects of the insole on balance capacity in chronic stroke.

详细描述

An important determinant of activities of daily living performance is standing balance. Therefore, poor balance, or postural stability, is significant predictors the risk of fall. After a fall, the patient can experience psychological, physical, social, economic, and sometimes fatal effects. The injuries can reduce the patient's mobility as well as independence and influence quality of life.Patients with chronic stroke wearing functional insoles and sham insoles to challenge balance tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A history of unilateral chronic stroke occurrence over 6 months prior to the study
  • Ability to understand verbal instructions.
  • Ability to walk 5 meters independently without the need of ankle-foot orthosis.

排除标准

  • A diagnosis of other neurological or musculoskeletal disorders that could affect postural balance.

研究组 & 干预措施

chronic stroke patient with insole

Experimental

Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.

干预措施: insole (Other)

chronic stroke patient without insole

Sham Comparator

Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall.

干预措施: insole (Other)

结局指标

主要结局

Change in Timed Up and Go (TUG) Test from pre to post-intervention.

时间窗: up to 10 minutes.

Timed Up and Go (TUG) Test was developed to assess mobility.

Change in Berg balance scale from pre to post-intervention.

时间窗: up to 30 minutes.

The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.

Change in Functional Reach Test(FRT) from pre to post-intervention.

时间窗: up to 10 minutes.

The Functional Reach Test (FRT) is a quick screen for determining risk for falls.

次要结局

  • Change in Center of pressure (CoP) from pre to post-intervention.(up to 30 minutes.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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