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临床试验/NCT06696040
NCT06696040Enrolling By Invitation不适用

Immediate Effects of Mobilization Performed by Passive Kinesiotherapy Equipment on Lower Limbs on Spasticity and Gait in Neurological Patients

Fernanda Trubian2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3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
Enrolling By Invitation
发起方
入组人数
80
试验地点
2
主要终点
Gait kinematics

研究概览

简要总结

Undergo assessment of muscle tone (Ashworth Scale), gait (BAIOBIT) and risk of falling (Timed Up and Go) before using the device; Use the device on the spastic lower limb(s) for 30 minutes; Go through the same assessment carried out previously.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • agree and sign the Free and Informed Consent Form or signature of the person responsible
  • individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)

排除标准

  • over 18 years old whose ability to sign the Free and Informed Consent Form is compromised, or who understand it, but are not responsible for signing the Free and Informed Consent Form
  • present cardiovascular, neurological, musculoskeletal instability or other condition(s) that interfere with the use or positioning of the device or gait assessment
  • present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
  • For the children's group, participants who: 1) are under 8 years of age and/or over 13 years of age will be excluded; 2) no person responsible for signing the TCLE; 3) present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol

研究组 & 干预措施

Pre-intervention and immediate post-intervention

Experimental

干预措施: Passive mobilization using a device (Device)

结局指标

主要结局

Gait kinematics

时间窗: Immediate post-evaluation (after using the device for 30 minutes)

Assessment of gait kinematics using the BAIOBIT pre and post intervention

次要结局

  • Muscle tone - spasticity(Immediately after using the device for 30 minutes)
  • Timed Up and Go(Immediately after using the device for 30 minutes)

研究者

发起方
Fernanda Trubian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fernanda Trubian

PhD student in Health Sciences

Universidade de Caxias do Sul

研究点 (2)

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