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临床试验/NCT04091594
NCT04091594撤回不适用

Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement

Virginia Commonwealth University1 个研究点 分布在 1 个国家开始时间: 2021年1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
撤回
试验地点
1
主要终点
Change in lower extremity kinematics and posture stability

研究概览

简要总结

The purpose of this research study is to use tools for measuring function and movement in pediatric populations to measure the impact of input orthotic interventions in children with cerebral palsy.

详细描述

Sensory processing begets movement. In persons with disorders of posture and movement due to cerebral palsy, an impaired ability to integrate multiple senses including pressure from ground, limb proprioception, and vestibular inputs leads to a movement pattern that is coarse, spastic and inefficient. In the pediatric rehab clinic spastic movement disorders have been treated with flexible, molded orthotics for the foot and ankle (AFO) to enhance sensation of ground reaction forces, and flexible elastomeric compression garments to enhance body and limb proprioception. While the investigators observed substantial improvements in gait quality and postural stability using sensory input orthotics, these clinical observations have not been objectively quantified. The goal is to use validated tools for measuring function and movement in pediatric populations in order to gather data on the value of sensory input orthotic interventions in children with cerebral palsy.

Under the term, sensory input orthotic, the following items are included which will be used in this study. 1) A flexible, thin polypropylene shell ankle-foot orthotic designed according to Hylton et al. Journal of P&O 1989. 2) Wearable elastomeric compression garments manufactured by SPIO or from the Boston Brace DMO garment line. 3) A vibrating anklet that provides subsensory vibrational stimulation to the leg, manufactured by Accelera.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of cerebral palsy
  • •Ages 6 months to 21 years
  • •No prior prescription of sensory input ankle-foot orthotics
  • •Clinical diagnosis of abnormal gait and mobility

排除标准

  • •Joint contracture that severely limits function such as ability to passively open the hand, extend the arm at the elbow or to stand with feet flat on the ground or knees in an extended position.

研究组 & 干预措施

Flexible orthotic

Experimental

Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments

干预措施: Flexible orthotic (Device)

Standard of care

Active Comparator

Standard of care solid ankle foot orthotic (AFO)

干预措施: Standard orthotic (Device)

结局指标

主要结局

Change in lower extremity kinematics and posture stability

时间窗: Baseline to 2 months

Participants will perform a 10 second walk test in the Motor Control Lab while being recorded with a Vicon 3D motion capture system.

Change in balance

时间窗: Baseline to 2 months

Participants will perform the 14-point items of the Pediatric Balance Scale in the Motor Control Lab while being recorded with a Vicon 3D motion capture system.

Change in perceived psychosocial well-being - parents

时间窗: Baseline to 2 months

Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)

Change in perceived psychosocial well-being - children

时间窗: Baseline to 2 months

Children ages 9 and up will be administered the Psychosocial Impact of Assistive Device Survey (PIADS) by a trained clinician

Change in gross motor function

时间窗: Baseline to 2 months

A trained physical therapist will administer the global gross motor function (GMFM-88) assessment

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 (1)

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