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临床试验/NCT03212664
NCT03212664已完成不适用

Effectiveness of Physical Therapy Exercises in Hyperkyphosis

Texas Scottish Rite Hospital for Children1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年8月5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
75
试验地点
1
主要终点
survey

研究概览

简要总结

This proposal is a single center preliminary prospective cohort trial that evaluates patients with hyperkyphosis. Participants will receive physical therapy exercises and be followed for the above outcome measures over time. The treatment arm will receive training in one-time training in kyphosis-specific exercises.

It is hypothesized that participants receive physical therapy exercises will demonstrate improved outcome measures over time. Also, it is hypothesized that participants who receive kyphosis-specific exercises will demonstrate significantly improved perceived quality-of-life and significantly reduced pain, compared to participants who receive generalized back exercises after 6 months.

Also, it is hypothesized that a kyphosis-specific SAQ will demonstrate satisfactory test-retest reliability and concurrent validity.

详细描述

A total of 50 patients will be recruited for this study. 28 patients will be recruited for both groups, or 14 participants per group. Patients will be randomized by an independent research assistant who will draw the group number from a hat. We assume less than 15% attrition, which results in 12 participants per group.

Patients in both groups will ideally be followed after 6 months, unless the patient's treating orthopaedic surgeon schedules them for a visit up until 12 months later.

Group 1(Kyphosis-specific exercise Group): Patients will receive a one-time treatment consisting of kyphosis-specific exercises that promote depressing the thoracic convexity.

Group 2 (Generalized exercise group): Patients will receive a one-time treatment consisting of core strengthening, hamstring stretching, and generalized back extension exercises.

Patients in each group will be asked to perform these exercises at home about 10 minutes a day, 3 times a week.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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
否

入选标准

  • •diagnosis of hyperkyphosis
  • •ages 10 to 18 years
  • •Cobb angles at least 50°
  • •pain >2 on the VAS during the past week.

排除标准

  • •scoliosis greater than 25°
  • •conditions preventing understanding and compliance with an exercise schedule
  • •current brace wear
  • •previous spine surgery
  • •inability to commit to at least 15 minutes of exercises for 3 days a week
  • •pain <2 on the VAS during the past week.

研究组 & 干预措施

Exercise

Other

Schroth-based physical therapy exercises for patients who agree to participate in exercises. Will be compared to observation-only treatment

干预措施: exercise (Other)

结局指标

主要结局

survey

时间窗: 6 month follow-up

19 items that identify factors related to exercise adherence, app usability and acceptability

次要结局

  • pain intensity(6 month follow-up)
  • pain intensity(baseline)

研究者

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

Karina Zapata, PT, DPT, PhD

research therapist

Texas Scottish Rite Hospital for Children

研究点 (1)

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