CompletedNot Applicable

Feasibility of the PERformance Guided Fracture Rehablitation Method-protocol

Netherlands20 participantsStarted 2022-04-24

Plain-language summary

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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion and exclusion criteria: The inclusion criteria: * Patients with a surgically treated (osteosynthesis) proximal humeral or distal radius fracture * Patients aged 18 to 70 years * Patients with a premorbid level with at least independent living and independence in ADL and/or HDL. * Patients are able to come to the Rehabilitation outpatient clinic of the Zuyderland MC in Heerlen for treatment * Patients are sufficiently instructable with regard to communication/language (NL/English) The exclusion criteria: * Multiple fractures to 1 limb * Pathological fractures * Complications such as trophic dysregulation/CRPS at the time of inclusion * Extensive concomitant neurovascular injury at the time of inclusion * Cognitive problems with regard to learnability and instructability * Influencing psychological problems or active substance use (with the exception of injury/trauma-related (movement) anxiety, event PTSD) * Influencing other problems/comorbidities to upper extremity such as neuromuscular disorders and anatomic anomalies * The subject is not prepared to conform to the informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of the PERFoRM-protocol at starting point of the study: qualitative assessment through standardized questionnaire.

Timeframe: at starting point of the study (before the first inclusion); at 0 months.

Feasibility of the PERFoRM-protocol at 6 months after the starting point of the study: qualitative assessment through standardized questionnaire.

Timeframe: 6 months after above-mentioned starting point of the study.

Trial details

NCT IDNCT05390463

SponsorZuyderland Medisch Centrum

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-28

View on ClinicalTrials.gov More Fracture of Proximal End of Humerus trials