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临床试验/NCT00438750
NCT00438750已完成不适用

Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Range of Motion in Degrees of the Wrists

研究概览

简要总结

The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

详细描述

Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.

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
None

入排标准

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

入选标准

  • Age 18 or greater.
  • Isolated distal radial fracture.
  • Fracture treated with volar plates, stable fixation.
  • Initial treatment within 4 weeks of trauma.

排除标准

  • Complex fractures that require additional or different material than volar plates.

结局指标

主要结局

Range of Motion in Degrees of the Wrists

时间窗: 6 months

Mean arc of wrist flexion and extension six months after surgery. Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.

次要结局

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire(6 months)
  • 10-point Ordinal Pain Scale(6 months)
  • Pinch Strength(6 months)
  • Gartland and Werley Score(6 months)
  • Mayo Wrist Score(6 months)
  • Grip Strength(6 months)

研究者

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

David C. Ring, MD

Principal Investigator; Director of Research, Hand Service

Massachusetts General Hospital

研究点 (2)

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