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临床试验/NCT05026359
NCT05026359Unknown不适用

Effects of Interlimb Coordination Coupling Training on Paretic Ankle and Lower Limb Motor Recovery Following Chronic Stroke

Taipei Medical University Shuang Ho Hospital3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
3
主要终点
Bilateral ankle coordination evaluation

研究概览

简要总结

The coordinated control between the bilateral ankles plays an important role in daily life functions such as walking and balance. The central nervous system damage caused by stroke, in addition to the limitation of the ankle movement on the hemiplegic side and the deterioration of the movement ability, It will seriously affect the coordinated control performance between the bilateral ankle joints, which will cause the majority of stroke patients to have barriers to walking function, and increase the patient's daily care depending on the caregiver. However, there is currently no research on stroke patients, the development of a coordinated control evaluation method with bilateral ankle joints, the use of load-bearing state simulation similar to the real-life bilateral ankle and foot coordination control performance, the establishment of clinical value of bilateral ankle Coordinating the performance parameters of the control evaluation; thus, the clinical doctors can not accurately understand the degree of defect in the bilateral foot and ankle coordination control of the stroke patients, and explore the influence of the bilateral ankle-foot coordination control defect on the daily life function of the stroke patients, and even cannot be based on the evaluation results. The clinical parameters, combined with visual feedback and bilateral rehabilitation advantages of rehabilitation training program, improve the bilateral ankle joint coordination control ability and lower limb function of stroke patients. Therefore, the purpose of this study is to establish an assessment system that can be used to measure the performance of bilateral ankle joint coordination control, to understand the degree of injury in bilateral ankle and foot coordination control, and to analyze the biped coordination parameters and clinical gait performance. The characteristics, and then the design of a double-sided rehabilitation training program combined with visual feedback, is used to improve the bilateral ankle joint coordination control performance and lower limb movement function of stroke patients.

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)

盲法说明

Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 6 months since stroke
  • three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history
  • ability to follow the researcher's instructions
  • the ability to flex and extend the paretic lower limb and ankle
  • Modified Ashworth Score (MAS) ≦3 for the ankle joints
  • a Mini-Mental State Examination (MMSE) score of 24 or higher
  • no other orthopedic or neurological disorders
  • Brunnstrom stage 4
  • no participation in other experimental rehabilitation or drug studies

排除标准

  • unstable cardiovascular conditions
  • uncontrolled hypertension (190/110 mm Hg)
  • severe orthopedic or pain conditions
  • dementia (Mini-Mental State Examination score < 22)
  • aphasia with inability to follow researcher's commands
  • Visual dysfunction
  • severe joint contracture of bilateral lower limb extremities that would impact the movement performance of the lower limb extremities

结局指标

主要结局

Bilateral ankle coordination evaluation

时间窗: Change from Baseline at 4 weeks

The foot (affected foot) first moves to 10° plantar flexion, and the other foot moves to 10° dorsiflexion for 10 seconds; then one foot gradually moves from 10° plantar flexion to 10° dorsiflexion, and the other foot moves from dorsiflexion 10° °Move to 10° plantar flexion.The "alternating time" and "alternating angle" values for coordination of bilateral ankles were calculated. To enable comparison of the alternating time and alternating angle applied for each subject, the data units were normalized as a percentage. We calculated the coefficient of variation (CV) values for the "alternating time" and "alternating angle"from the non-dominant (non-paretic) ankle to the dominant (paretic) ankle. This revealed the overall variation in alternating time and alternating angle on the coordination control of individuals in this study.

次要结局

  • Barthel Index (BI)(Change from Baseline at 4 weeks)
  • Lower Extremity motor control of Fugl-Meyer Assessment (FMA-LE)(Change from Baseline at 4 weeks)
  • Gait kinematics evaluation(Change from Baseline at 4 weeks)
  • Berg Balance Test (BBS)(Change from Baseline at 4 weeks)
  • Time Up and Go Test (Time Up and Go, TUG)(Change from Baseline at 4 weeks)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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