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临床试验/NCT06266637
NCT06266637进行中(未招募)不适用

Effect of Physiotherapeutic Scoliosis-Specific Exercise on Lower Limb Biomechanics in Adolescents With Idiopathic Scoliosis: A Randomised Controlled Trial

Delta University for Science and Technology2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
56
试验地点
2
主要终点
knee joint line convergence angle

研究概览

简要总结

PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.

HYPOTHESES:

Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.

RESEARCH QUESTION:

What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?

详细描述

procedures: A randomized controlled clinical trial will be conducted

Assessment:

x-ray computed scanogram radiography of the whole spine and both lower limbs in standing will be used.

The following measurements will be taken pre and post the treatment program:

For the lumbar spine coronal alignment:

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Adolescents with age 10-18 years
  • complaining of dorsolumbar scoliosis
  • curves (apex lies between D10 and L4)
  • curve magnitudes greater than 15 degrees and less than 90
  • using or not using brace
  • all maturity levels (Risser = 0-5)

排除标准

  • Other types of scoliosis ; congenital or neuromuscular
  • Current physical therapy or medical treatment for scoliosis,
  • Contracture or surgery affecting the lumbar spine or lower limbs
  • Pathologies such as inflammatory diseases
  • congenital anomalies
  • Neurological disorders like cerebral palsy or ataxia
  • dislocations
  • visual or auditory problems

研究组 & 干预措施

Study group

Experimental

The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise

干预措施: Conventional Physical Therapy Program (Other)

Study group

Experimental

The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise

干预措施: Physiotherapeutic Scoliosis-Specific Exercise (Schroth) (Other)

Control group

Active Comparator

The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises .

干预措施: Conventional Physical Therapy Program (Other)

结局指标

主要结局

knee joint line convergence angle

时间窗: From enrollment to the end of treatment at 6 months

The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)

Cobb's angle

时间窗: From enrollment to the end of treatment at 6 months

Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)

Coronal balance

时间窗: From enrollment to the end of treatment at 6 months

Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )

lower limb mechanical axis; and mechanical axis deviation

时间窗: From enrollment to the end of treatment at 6 months

The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).

length of the the tibia and femur

时间窗: From enrollment to the end of treatment at 6 months

The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)

tibiofemoral angle

时间窗: From enrollment to the end of treatment at 6 months

The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)

次要结局

未报告次要终点

研究者

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

Omar Mohamed Ali Elabd

Lecturer of Orthopedic Physical Therapy

Delta University for Science and Technology

研究点 (2)

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