Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
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
Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments
干预措施: Flexible orthotic (Device)
Standard of care
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
