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临床试验/NCT01921062
NCT01921062终止不适用

Kinesthetic Motor Imagery Training During Immobilization to Improve Wrist Functional Outcome After a Distal Radius Fracture in Women of 45-75 Years of Age

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
66
试验地点
2
主要终点
Hand Function

研究概览

简要总结

The aim of this study is to determine whether motor imagery training during the immobilisation period in patients with a distal radius fracture, results in an improved functional outcome compared to patients who do not perform motor imagery.

详细描述

Rationale: Distal radius fracture (DRF) is a common injury that may lead to prolonged function restrictions, decreased range of motion, reduced grip strength and pain. These symptoms may be caused by physical changes due to the injury and/or by the 4-6 weeks immobilization that is part of the conservative treatment. However, it might also be that neural changes during the immobilization play an important role. Such changes might be prevented by motor imagery training during the immobilization period. So, when neural changes are prevented, this may lead to a better functional outcome.

Objective: The objective is to improve the functional outcome in distal radius fracture patients, specified as an increase in function, dexterity, grip strength, range of motion, and decrease of pain.

Study design: Parallel group randomized controlled trial, with a post-test only control group design. Patients in the experimental group perform motor imagery training during the immobilization period, in addition to the regular treatment. Patients in the control group receive regular treatment.

Study population: Female DRF-patients who are conservatively treated by a cast, aged 45-75 years. The fracture must be a low energy trauma caused by a fall. Patients with a score higher than 72 on the Vividness of Motor Imagery Questionnaire (VMIQ) are excluded, as well as patients with co-morbidities that might influence the wrist function, or motor imagery-ability, and patients with no understanding of Dutch language. The patients are randomly allocated to the experimental or control group by restricted randomization to ensure equal group sizes.

Intervention: Motor imagery training during the immobilization period).

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
45 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female patients
  • non-comminutive distal radius fracture
  • 45 to 75 years of age

排除标准

  • distal radius fracture caused by HET
  • comorbidities possibly influencing wrist function
  • comorbidities possibly influencing motor imagery ability
  • score higher than 72 on the Vividness of Motor Imagery Questionnaire

结局指标

主要结局

Hand Function

时间窗: 2 days after cast removal

Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function)

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

D.C. Broekstra

MSc

University Medical Center Groningen

研究点 (2)

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