跳至主要内容
临床试验/NCT07343752
NCT07343752招募中不适用

Does Adding Blood Flow Restriction Training to the Physical Therapy Program Improve Outcomes in Adolescents With Spasmodic Flatfoot Deformity?

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
American Orthopedic Foot and Ankle score (AOFAS)

研究概览

简要总结

The goal of this randomized clinical trial is to evaluate the efficiency and results of adding blood flow restriction (BFR) training to the physical therapy program for managing adolescents presented with spasmotic flatfoot deformities compared to the Standard physical therapy program without blood flow restriction.

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

入选标准

  • Adolescents presented with idiopathic, rigid, spasmodic flatfeet.
  • Age should be younger than 18 years old. 3- Patients who did not respond to initial medical treatment for three weeks.

排除标准

  • generalised tarsal arthritis
  • neurological disorder.
  • secondary rigid flatfoot deformity
  • patients who did not complete the follow up or evaluation protocol
  • Patients who will refuse to participate

结局指标

主要结局

American Orthopedic Foot and Ankle score (AOFAS)

时间窗: baseline and 2 months

Ankle-Hindfoot Scale: a standard method of reporting the clinical and functional status of the ankle and foot. The systems incorporate both subjective and objective factors into numerical scales to describe function, alignment, and pain. A score of 100 points is possible in a patient with no pain, full range of sagittal and hindfoot motion, no ankle or hindfoot instability, good alignment, ability to walk more than six blocks, ability to ambulate on any walking surface, no discernible limp, no limitation of daily or recreational activities, and no assistive devices needed for ambulation. Fifty points were assigned to function, 40 to pain, and 10 to alignment.

Range of motion (ROM)

时间窗: baseline and at last follow up, 2 months

Ankle range of motion of the sagittal plane (dorsiflexion and plantar flexion) and in the coronal plane (inversion and eversion), using a goniometer.

次要结局

  • Muscle power(baseline and at last follow up, 2 months)
  • Numerical Pain Rating Scale (NPRS).(baseline and at last follow-up, 2 months)
  • Patient satisfaction(last follow up, 2 months)

研究者

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

Mariam ibrahim

Physical tharapist

Assiut University

研究点 (1)

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