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临床试验/NCT04090892
NCT04090892已完成不适用

Effects of Selective Percutaneous Muscle Lengthening on Gait in Children With Spasticity

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年5月10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
8
试验地点
1
主要终点
Kinematic Change is being assessed

研究概览

简要总结

This research project is being conducted to investigate changes in secondary impairments, functional mobility skills, and gait variables in children with spasticity following selective percutaneous myofascial lengthening. The research project proposed here will be the first to use instrumented three-dimensional motion analysis to investigate the effects of selective percutaneous myofascial lengthening on gait kinematics and kinetics. The objectives of the study are to:

  1. Compare gait kinematics and kinetics in children and young adults with lower extremity spasticity before and after selective percutaneous myofascial lengthening to determine the effects of this procedure on functional mobility.
  2. Identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening .
  3. Identify changes in a family or caregivers perceived quality of life after their child's selective percutaneous myofascial lengthening .

The aim of this study is to identify and describe the specific changes in secondary musculoskeletal impairments, activity limitations, and gait kinematics and kinetics after a selective percutaneous myofascial lengthening procedure. Gait kinematics and kinetics includes the motion of joints and body segments, and force and power, at each lower extremity joint, respectively. The results of this study will provide preliminary information on how this form of soft tissue lengthening affects functional mobility skills in children with spasticity. The study is expected to run for two years and the primary study endpoint is when participants have completed their second post- operative data collection session.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for an selective percutaneous myofascial lengthening procedure,
  • Between the ages of 4.0 and 20.11 years old,
  • Lower extremity spasticity,
  • Able to ambulate 50 feet without a rest, with or without an assistive device, and with or without ankle foot orthoses (AFOs) and
  • Able to follow one step directions.

排除标准

  • Botox injections into any lower extremity muscle within three months of the scheduled selective percutaneous myofascial lengthening procedure,
  • Lower extremity orthopedic surgery within 6 months of the scheduled selective percutaneous myofascial lengthening procedure,
  • Visual impairment that interferes with maintaining a straight path while ambulating,
  • Uncontrolled seizure disorder
  • A change in medication that affects spasticity or ability to follow one step directions within three months of the scheduled selective percutaneous myofascial lengthening procedure.

结局指标

主要结局

Kinematic Change is being assessed

时间窗: Outcomes measures will be administered 6 months after surgery to assess long term change.

Lower extremity joint angles after surgery

次要结局

  • Gross Motor Function Measure - Change is being assessed(Outcomes measures will be administered at 6 months after surgery to assess long term change.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Simpkins

Associate Professor

University of Texas Southwestern Medical Center

研究点 (1)

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