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临床试验/NCT05688072
NCT05688072已完成不适用

Trunk Oriented Exercises Versus Whole-body Vibration on Abdominal Thickness and Balance in Children With Duchenne Muscular Dystrophy

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月15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
30
试验地点
1
主要终点
abdominal muscle thickness

研究概览

简要总结

The abdominal muscles play an important role in stabilizing the trunk and providing postural stability. Children with Duchene muscular dystrophy have weak muscles, which may impair postural adjustments. These postural adjustments are required for gait and dynamic balance during the daily living activities.

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)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed as Duchenne muscular dystrophy,
  • •aged from 6 to 10 years,
  • •having grade 3+ muscle strength in lower limbs and trunk muscles.
  • •had functional range of motion for upper and lower limb joints,
  • •able to walk alone level I and II of Ambulation function classification system for DMD (AFCSD)

排除标准

  • •congenital or acquired skeletal deformities or cardiopulmonary dysfunction,
  • •had undergone previous orthopedic surgery in lower limbs,
  • •had abnormal motor development or neurological disease that affect balance
  • •and gait, and
  • •behavioral problems causing inability to cooperate during the study.

研究组 & 干预措施

study group (A)

Active Comparator

干预措施: trunk oriented exercise (Other)

Study group (B)

Active Comparator

干预措施: whole body vibration (Other)

结局指标

主要结局

abdominal muscle thickness

时间窗: change from base line at 4 weeks.

The thickness of four abdominal muscles will be measured with ultrasonography (device type GE Logiq P6) with a frequency of 7.5 MHz. The probe will be placed 2 or 3 cm from the midline, using the umbilicus as a landmark, then will be moved in a semi-circular motion until the deepest image on the screen, the TA, will be visible. To confirm this position and measure the thickness, a skin marker pen will be used. The probe will be then moved in an oblique manner to detect the thickness of the EO, IO, RA, and TA. A large amount of contact gel will be used, and the probe pressure will be adjusted to obtain optimal values of muscle thickness. After image capture, a vertical line will drawn between the superficial and deep aponeurosis to determine muscle thickness.

次要结局

  • balance assessment(change from base line at 4 weeks.)

研究者

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

Marwa Shafiek Mustafa Saleh

assistance professor doctor

Cairo University

研究点 (1)

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