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临床试验/NCT04841161
NCT04841161已完成不适用

Development of an Intelligent Balance Training System Providing Weight-bearing Feedback Via Force Platform to Improve Sit-to-stand, Dynamic Weight-shifting and Standing Performance in Stroke Patients

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Changes in performance of weight distribution after 8 sessions intervention

研究概览

简要总结

The sit-to-stand and dynamic weight-shifting ability of stroke patients is highly associated with walking performance. Therefore, in order to improve the dynamic weight-shifting ability in sit-to-stand and parallel or tandem standing, a real-time visual or auditory feedback is used in our design to allow patients to realize the weight-bearing condition (by using load cells) in both sound and affected legs immediately. It can help patients to learn to control muscle to shift weight effectively which will improve patients' walking performance. By integrating physical therapy planning with electro-mechanical technology, the goal of this study is to develop a standing balance training system by requiring patients to control their center of pressure (COP) in performing sit-to-stand and maintain a standing posture via the use of their core and lower extremity musculature.

详细描述

  1. Written informed consent must be obtained before any study specific procedures are undertaken.

  2. For healthy group: Participants will be recruited from the staffs and students in Kaohsiung Medical University (including Learning University), and healthy families of CVA patients in the university affiliated hospital.

  3. For stroke (CVA) group: We will ask the physical therapists in the university affiliated hospital to nominate the potential CVA participants . The physicians will determine if they would meet the inclusion criteria before participating the present study.

  4. The process of the experiment (brief describe)

  5. Written informed consent must be obtained before any study specific procedures are undertaken.

  6. Subjects who are recruited to participate in this experiment should provide the personal information forms first (ex: sex, age, height, weight, post-stroke duration, stroke type, hemiplegic side, ambulation devices etc.). Then, assessment (PASS, Berg Balance Scale, Timed Up and Go) will be conducted by a physical therapist at baseline.

  7. While the stroke patients after completing the 4 -times, and 8-times training program, the above-mentioned assessment conducted again by the same physical therapist. The healthy will not receive balance training, thus .only receive one assessment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults
  • a. Their age should be ranged between 20 - 75 years
  • Stroke patients
  • diagnosed with unilateral ischemic or hemorrhagic stroke
  • a minimum of six months post stroke
  • able to stand without support for 1 minutes
  • medically stable with physician release

排除标准

  • Healthy adults
  • neurological diseases
  • musculoskeletal diseases
  • rheumatic diseases
  • history of orthopedic surgery on spine or lower extremity
  • Stroke patients
  • other injuries or illnesses that affect standing or walking

结局指标

主要结局

Changes in performance of weight distribution after 8 sessions intervention

时间窗: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)

By using the force plate to record the ground reaction force and then to obtain weight distribution while performing the sit to stand activity

Changes in performance of dynamic balance after 8 sessions intervention

时间窗: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)

By using Timed Up and Go Test (TUG) to assess fall risk and measure the progress of balance. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.

Changes in performance of balance function after 8 sessions intervention

时间窗: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)

By using the Berg Balance Scale to assess balance function. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4during a series of predetermined tasks. The total score ranges from 0 - 56.

Changes in performance of standing balance after 8 sessions intervention

时间窗: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)

By using the force plate to obtain displacements of the center of pressure (COP) while standing and weight transfer

Changes in performance of static and dynamic balance after 8 sessions intervention

时间窗: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)

By using the Postural Assessment Scale of Stroke (PASS) to assess and monitor postural control. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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