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临床试验/NCT06153992
NCT06153992招募中不适用

Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology

Ran Shi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Body function

研究概览

简要总结

The goal of this clinical trial is to compare in describeparticipant population. The main question it aims to answer is:By using intelligent portable isokinetic tester and traditional isokinetic tester, isokinetic knee flexor and extensor muscles of stroke patients with hemiplegia were trained respectively, so as to observe and compare the effects of the two treatment methods. In addition, the therapeutic effect of the above two treatments was compared with that of exercise therapy alone. Participants will be divided into three groups: control group, intelligent isokinetic treatment group, and traditional isokinetic treatment group. Participants of both the control group and the two treatment groups received exercise therapy. On the basis of exercise therapy, participants of the intelligent isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle, while the participants of traditional isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle.

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, Care Provider)

入排标准

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

入选标准

  • Clinical diagnosis of Cerebral apoplexy's Disease
  • Confirmed by CT or MR Examination of the head
  • First onset, duration ≤1 month
  • The lower extremity of the hemiplegic limb was above Brunnstrom stage III
  • Must be able to sign the informed consent form

排除标准

  • Vital signs are unstable
  • Severe cognitive, visual and hearing impairment
  • Orthopaedic disease
  • Muscle pain lower extremity
  • Congenital disease
  • History of other encephalopathy
  • History of mental illness

结局指标

主要结局

Body function

时间窗: up to 1 month

Evaluate lower limb motor function using the Fugl Meyer method (total lower limb motor score 0-34 points, total balance score 0-14 points).

Measured peak moment

时间窗: up to 1 month

Peak moment of knee joint at 60 °/s angular velocity in Nm

次要结局

  • Satisfaction questionnaire survey(up to 1 month)

研究者

发起方
Ran Shi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ran Shi

doctor

Qianfoshan Hospital

研究点 (1)

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