Feasibility of the PERformance Guided Fracture Rehablitation Method (PERFoRM) Protocol for Periarticular Upper Extremity Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of the PERFoRM-protocol at 6 months after the starting point of the study: qualitative assessment through standardized questionnaire.
研究概览
简要总结
Introduction: The scientific support for prescribed rehabilitation programs for upper extremity fractures is scarce, early mobilization has previously been shown to benefit the speed of recovery at the activity and participation level. Different (inter)national protocols for fracture rehabilitation of the upper extremity are not very specific with regard to the content of (para)medical treatment. The above underlines the need for a clearly defined and practically feasible treatment method.
That is why the PERformance guided Fracture Rehablitation Method (PERForRM) protocol was drawn up, in which the treatment method is clearly described in a structured and protocol-based manner. The ultimate goal of the PERformance guided Fracture Rehablitation Method (PERFoRM) protocol is to optimize recovery, with maximum recovery of activity and participation level in upper extremity fractures. Expert opinion/empiricism was used during the writing of the protocol, partly arising from the earlier development of a protocol for the lower extremity. The approach according to the PERForRM protocol does not focus on the time-contingent load on the fracture, but rather on the functional use of the extremity, whereby the quality of movement is paramount. The PERForRM protocol proposes a "gold standard" in the form of milestones for describing the quality of movement of the upper extremity for (para)medics.
Method:
The aim of this pilot study is to test the manageability/feasibility of this protocol in clinical practice in patients with peri-articular fractures of the upper extremity (proximal humeral and distal radius fractures). It also describes the recovery in the area of the ICF domains and the complications that occurred when applying the PERForRM protocol. The inclusion period consists of 3 months, with a follow-up of 6 months. The manageability is measured by means of a questionnaire that is administered to the practitioners (2x during the study period). The data analysis will mainly have a descriptive character
详细描述
Research question:
Question 1: How has the feasibility of the PERFORM protocol been applied in patients with peri-articular fractures of the upper extremity (operated proximal humeral and distal radius fractures)? Question 2a: How is the recovery on the different ICF domains after applying the PERFORM protocol in patients with peri-articular fractures of the upper extremity (proximal humeral and distal radius fractures) compared to results already described in the literature with regard to recovery (semi-structured treatment / protocols) after related fractures? Question 2b: Is the number of complications occurring when applying the PERFORM protocol equal to the results already described in the literature with regard to recovery (semi-structured treatment / protocols) after the relevant fractures?
Hypothesis:
Question 1: The PERForRM protocol can be used by both physicians and paramedics in the trauma rehabilitation chain. Experiences of physicians and paramedics show that the protocol is useful and applicable within the patient population (patients with peri-articular fractures of the upper extremity (operated proximal humeral and distal radius fractures)).
Question 2a: Patients with peri-articular fractures of the upper extremity treated with the PERFORM protocol show comparable or faster recovery in the different ICF domains compared to patients with peri-articular fractures of the upper extremity (proximal humerus). - and distal radius fractures) treated with a different post-treatment protocol (often diverse and semi- or only globally structured) as described in the literature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility of the PERFoRM-protocol at 6 months after the starting point of the study: qualitative assessment through standardized questionnaire.
时间窗: 6 months after above-mentioned starting point of the study.
Feasibility of the PERFoRM-protocol: qualitative assessment through standardized questionnaire (questionnaire composed by investigator).
Feasibility of the PERFoRM-protocol at starting point of the study: qualitative assessment through standardized questionnaire.
时间窗: at starting point of the study (before the first inclusion); at 0 months.
Feasibility of the PERFoRM-protocol: qualitative assessment through standardized questionnaire (questionnaire composed by investigator).
次要结局
- Change of rate of disability of (affected) arm-shoulder-hand.(Change between immediate phase (0-2 weeks) post-surgery, 6 weeks post-surgery, 3 months post-surgery, 6 months post surgery.)
- Change in pain of affected limb.(Change between immediate phase (0-2 weeks) post-surgery, 6 weeks post-surgery, 3 months post-surgery, 6 months post surgery.)
- Change in handstrength of affected limb.(Change between immediate phase (0-2 weeks) post-surgery, 6 weeks post-surgery, 3 months post-surgery, 6 months post surgery.)
- Change in general health status.(Change between immediate phase (0-2 weeks) post-surgery, 3 months post-surgery, 6 months post surgery.)