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The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores

2018年8月30日 更新者:Alice Ørts Hansen、Odense University Hospital

Background Patients with the same type of hand injury often reach different functional levels. Therefore, it is necessary to investigate what kind of rehabilitation is most efficient for each individual patient.

Research has shown that a person's "Sense of Coherence" (SOC) affects how he /she deals with disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and should therefore; be taken into consideration when planning rehabilitation. It was concluded in a study that patients with a weak SOC who have had a hand injury, may benefit from extra support to manage their everyday activities in order to reach the same final outcome as patients with a strong SOC.

Purpose To investigate two types of rehabilitation on patients with a hand-related injury (joint mobility exercises vs. activity-based training and joint mobility exercises) and to investigate whether SOC can be used as an indicator of which patients would benefit from activity-based training.

Hypotheses

  1. Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program.
  2. Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program.
  3. Patients with a strong SOC will not achieve a higher functional level, if activity-based training is included in their rehabilitation program.

Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or older are included when referred to specialized outpatient occupational therapy after a hand-related injury. To ensure sufficient and balanced patient variation in relation to pre-rehabilitation sense of coherence, a balanced randomisation principle has been implemented.

Data will be collected through questionnaires. The questionnaires measure SOC (13 items version), function (DASH), quality of life (EQ5D) and satisfaction.

All participants will perform joint mobility exercises which are appropriate for their injury. In addition, participants who will be performing activity-based training will train with specific meaningful activities which they performed prior to the hand-related injury.

Clinical relevance The knowledge obtained will be incorporated into the planning of occupational therapy rehabilitation services for this patient group, so that the patients will receive the most optimal conditions in which to achieve their previous level of function after a hand injury.

研究概览

研究类型

介入性

注册 (实际的)

504

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Odense、丹麦、5000
        • Odense University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with hand-related diagnoses (acute injuries or elective surgeries)
  • Patients referred to specialized outpatient occupational therapy rehabilitation at Odense University Hospital
  • Patients who are able to understand, speak and read enough Danish to participate
  • 18-years of age or older

Exclusion Criteria:

  • A rehabilitation treatment period under four weeks and less than three treatments
  • Dementia or cognitive impairments
  • Where it is not considered medically or therapeutically safe to allow the patient to be included in the randomization process.
  • Patients with shoulder problems
  • Patients with epicondylitis
  • Patients with plexus brachialis injuries
  • Patients who only have difficulty extending their non-dominant 5th finger.
  • Burn injuries
  • Pt. who have had a CMP joint replacement operation because of arthrosis (Swanson)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:strong sense of coherence control group
Patients with a strong sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
实验性的:strong sense of coherence intervention
Patients with a strong sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury. This will be performed both in the therapy setting and as a home exercise program.
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
有源比较器:weak sense of coherence control group
Patients with a weak sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
实验性的:weak sense of coherence intervention
Patients with a weak sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury. This will be performed both in the therapy setting and as a home exercise program.
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
实验性的:medium sense of coherence intervention
Patients with a medium sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury. This will be performed both in the therapy setting and as a home exercise program.
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
有源比较器:medium sense of coherence control group
Patients with a weak sense of coherence. Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Disabilities of the Arm, Shoulder, and Hand questionnaire
大体时间:from baseline to 12 months after start of rehabilitation
from baseline to 12 months after start of rehabilitation

次要结果测量

结果测量
措施说明
大体时间
The EQ-5D Quality of life questionnaire
大体时间:From baseline to 3 months
From baseline to 3 months
Sense of Coherence Questionnaire
大体时间:From baseline to 12 months
13 items questionnaire
From baseline to 12 months
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
大体时间:From baseline to 3 months
From baseline to 3 months
Satisfaction with daily living and rehabilitation
大体时间:From baseline to12 months
From baseline to12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Hans B Tromborg, Ph.D、University of Southern Denmark

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年2月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2014年3月21日

首先提交符合 QC 标准的

2014年3月27日

首次发布 (估计)

2014年3月28日

研究记录更新

最后更新发布 (实际的)

2018年8月31日

上次提交的符合 QC 标准的更新

2018年8月30日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • REHAB123

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