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临床试验/NCT03191552
NCT03191552已完成不适用

The Effect of Vest Type Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Children With Bilateral Cerebral Palsy: A Feasibility and Randomized, Single-blinded, Pilot Study

Marmara University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Sitting Assessment Scale

研究概览

简要总结

To evaluate the effects and feasibility of lycra based compression garment called Stabilizing Pressure Input Orthosis (SPIO) vest on posture and balance during sitting and gross manuel dexterity, parent satisfaction with the garment and to to compare 2 hours vs 6 hours of daily wear time.

详细描述

Cerebral palsy (CP) is a disorder of development of movement and posture due to non-progressive lesion in fetal or infant brain. Postural control in children with cerebral palsy (CP) is deteriorated due to inappropriate muscle force and lack of sensory integration. The trunk which is found in the centre of the body plays a crucial role in postural control. Research and treatments in CP have focused on extremities rather than trunk control. Both evaluation and treatment of trunk impairment have not been adequately addressed in previously published studies. Improved proximal stability obtained by a better trunk control may lead to improvements in upper extremity function.

Dynamic elastomeric fabric orthosis (DEFO) which are lycra based compression garments provide extra proprioceptive information which enhances body awareness. The more correct proprioceptive input result in the more proper alignment. Vest type dynamic elastomeric fabric orthosis (DEFO) is composed of a front part which is compromised of double-or triple-layer of lycra fabric attached to velcro sensitive neoprene back panel. Thus, it provides adjustable compression around the shoulder, trunk, pelvis, and hips. It is proposed that these orthotic garments provides stabilization of the trunk, shoulder and pelvis girdle and thus improve proximal stability and upper extremity function. Children with sensory deficits and poor muscle strength including children with neuromotor developmental disorders and hypotonia can benefit from the use of vest type dynamic elastomeric fabric orthosis. Severe restricted pulmonary function and refractory cyanosis are absolute contraindications for lycra based orthosis use while having severe reflux symptoms, uncontrolled epilepsy, cardiovascular circulatory disorders and being diagnosed with diabetes are relative contraindications. The adverse events pertaining to the use of these orthoses are difficulty in donning/doffing, toileting problems such as constipation and urinary leakage, decrease in respiratory function, heat and skin discomfort. Due to those unwanted effects, it can be assumed that longer wear time of the orthosis may lower compliance. However, the optimal wear time for vest type dynamic elastomeric fabric orthosis has not been established so far. The reported wear time of suit therapies range from 2 to12 hours a day during 2-12 weeks. The aim of this study was to investigate if the use of a vest type dynamic elastomeric fabric orthosis (DEFO) vest type dynamic elastomeric fabric orthosis is feasible or not and will lead to improvement in sitting balance, sitting as a gross motor function and gross manuel dexterity. The secondary purposes of the present study are to evaluate parent satisfaction with the orthosis and to compare 2 hours vs 6 hours of daily wear time.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • being classified at Gross Motor Function Classification System (GMFCS) level III-IV
  • being classified at Manual Ability Classification System (MACS) level III-IV
  • being able to understand and execute given instructions for evaluations
  • parental acceptance of using the lycra based compression garment.

排除标准

  • serious respiratory restriction
  • having refractory cyanosis or circulatory disorder
  • having undergone lycra compression orthosis treatment programme previously
  • having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year
  • severe scoliosis (Cobb angle (CA) >40°)
  • uncontrolled epilepsy
  • having intrathecal baclofen pump
  • having undergone selective dorsal rhizotomy
  • having reflux more than 3 times a week.

研究组 & 干预措施

SPIO 2 hours

Experimental

All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.

SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.

干预措施: SPIO (Device)

SPIO 2 hours

Experimental

All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.

SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.

干预措施: conventional exercises (Other)

SPIO 6 hours

Experimental

SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.

干预措施: SPIO (Device)

SPIO 6 hours

Experimental

SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.

干预措施: conventional exercises (Other)

Control(conventional exercises)

Active Comparator

Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks

干预措施: conventional exercises (Other)

结局指标

主要结局

Sitting Assessment Scale

时间窗: 3 months

Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively

次要结局

  • Gross Motor Function Measure-B, Sitting Dimension(3 months)
  • Box and Block Test (BBT)(3 months)
  • Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)(3 months)
  • Parent Satisfaction Questionnaire Total Score(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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