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临床试验/NCT02913222
NCT02913222已完成不适用

Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders

Washington University School of Medicine4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
4
主要终点
Percentage of Participants Who Are Adherent to Treatment Attendance

研究概览

简要总结

Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is needed to improve function in the young adult and prevent or delay the onset of hip OA, however evidence related to treatment of PAHD is limited. This research will provide the foundation for a future clinical trial to assess the efficacy of movement pattern training, an innovative rehabilitation approach for the treatment of PAHD.

详细描述

Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis. The number of surgical procedures to treat PAHD has grown exponentially in the past decade, despite the lack of high level evidence to guide treatment decisions. The potential exists for surgery to become standard treatment before rigorous investigation of treatment options has been completed. This trend may be partially due to a lack of evidence related to rehabilitation. Although some authors believe rehabilitation can improve function in people with PAHD, others state that rehabilitation is contra-indicated and recommend surgery as the best option. There are no published clinical trials to support or refute either opinion, therefore little is known about the comparative effectiveness of rehabilitation.

Innovation: The investigators' long term goal is to develop effective treatment strategies for people with PAHD that will improve function and prevent or delay the onset of OA. Movement pattern training is an innovative rehabilitation approach designed to reduce stresses on the hip joint by optimizing the biomechanics of functional tasks through task-specific instruction. Preliminary work suggests that abnormal movement patterns may be associated with PAHD and that movement pattern training may be an effective treatment approach, however comparison to standard rehabilitation has not been completed.

Purpose: This study was designed to assess the feasibility of conducting a multicenter randomized clinical trial (RCT) to determine the efficacy of movement pattern training compared to standard rehabilitation for people with PAHD. Participants enrolled at Washington University and University of Pittsburgh will be randomized into one of two treatment groups, movement pattern training or standard rehabilitation. In addition to assessing feasibility of the trial, preliminary estimates of effect sizes for treatment outcomes will be obtain in preparation for the future definitive trial. Post-treatment improvements in patient-reported function as measured by the Hip disability and Osteoarthritis Outcome Score and hip adduction motion during functional tasks, a proposed mechanistic factor associated with PAHD will be assessed. Upon completion of this study, the investigators will be positioned to implement a multicenter RCT to definitively assess the efficacy of movement pattern training.

Impact: Ultimately, if movement pattern training is determined to be effective, it will provide a relatively inexpensive alternative to surgical intervention. Further, the theoretical concepts of movement pattern training could be used to possibly serve a role in injury prevention, as well as optimize post-surgical outcomes in those who do require surgery.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • be 15-40 years old
  • report deep hip joint or anterior groin pain, confirmed upon physical exam
  • report pain > 3/10 and present > 3 months
  • demonstrate functional limitation with modified Harris Hip Score <90.

排除标准

  • previous hip surgery, fracture, pelvic/hip infection
  • pain due to high impact trauma
  • inflammatory disease, e.g. rheumatoid arthritis, gout
  • neurological involvement affecting balance
  • age <15 or >40
  • Slipped Capital Femoral Epiphysis (SCFE) or Legg-Calve-Perthes Disease (LCP)
  • pain, numbness or tingling that radiates into the thigh
  • known pregnancy

结局指标

主要结局

Percentage of Participants Who Are Adherent to Treatment Attendance

时间窗: Immediately after treatment (13 weeks after baseline)

Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions.

次要结局

  • Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks)(Immediately after treatment (13 weeks after baseline))
  • Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks)(Immediately after treatment (13 weeks after baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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