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临床试验/NCT06037044
NCT06037044进行中(未招募)不适用

The Effect of Sensory Integration Balance Training Compared With Traditional Balance Training for Children With Acquired Brain Injury (ABI)

Princess Nourah Bint Abdulrahman University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
Timed up and go (TUG)

研究概览

简要总结

This study aim to investagte the effectivness of sensory integartion balance training during gait training with obstecles and stimulation to different sensation, in comparission to gait training with obstecles without sensory stimulation among children with acuired brain injury

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
Single (Outcomes Assessor)

盲法说明

Assessor will be blinded to group allocation

入排标准

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

入选标准

  • Children with ABI, able to walk with or without assistance, GMFCS level I-III, aged 4-12 years old, with subjective symptoms of balance impairments, fear of falling and/or history of falls

排除标准

  • Botox injections or tendon release surgery in the past six months

结局指标

主要结局

Timed up and go (TUG)

时间窗: One week before and after training then one month after training

It is a simple evaluative test used to measure functional mobility and show how safely a patient can move around. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down while timing.

Obstacle Test

时间窗: One week before and after training then one month after training

It is a timed walking test. Time is calculated while the child is walking stepping over two obstacles and walking around a basket. The pathway is 8.5 meter and the start and end lines are marked. Time is calculating as the child walking between the lines and accomplishing the obstacles. Hight of the obstacle is 15% of the child leg length, while the width is 10%. The basket was around 56 centimeters in width and 69.5 centimeters in length. The child should stand behind the start line and walk in a straight line then step over the obstacles, walk around one side of the basket then pass the end line.

Pediatric balance scale (PBS)

时间窗: One week before and after training then one month after training

It was developed as a balance measure for children. The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the functional balance skills for school-age children with mild-to-moderate motor impairments. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. These items include moving from a seated to a standing position, moving from a standing position to a sitting position, transfer, standing without support, sitting without support, standing with eyes closed, standing with feet together, standing with one foot in front of the other, standing on one foot, rotating 360 degrees, turning to look back, picking up an object off the floor, placing alternate foot on step or footrest, and reaching forward with an extended arm.

Gross motor functional measure (GMFM)

时间窗: One week before and after training then one month after training

It is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. It has 88 items to explore motor ability in five dimensions; lying and rolling, sitting, crawling and kneeling, standing, and walking, running and jumping

次要结局

  • One min sit to stand test (1-MSTST)(one week before and after training then one month after training)
  • The Pediatric Quality of Life Inventory (PedsQL)(one week before and after training then one month after training)

研究者

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

Afrah Almuwais

Assistant prof

Princess Nourah Bint Abdulrahman University

研究点 (1)

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