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NCT05390463: PERFoRM
Feasibility of the PERformance Guided Fracture Rehablitation Method-protocol
trial testing PERformance guided Fracture Rehablitation Method (PERFoRM) protocol. in Fracture of Proximal End of Humerus in 20 participants. Completed in 28 November 2023.
28 November 2023
Quick facts
| Lead sponsor | Zuyderland Medisch Centrum |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 24 April 2022 |
| Primary completion | 28 November 2023 |
| Estimated completion | 28 November 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- PERformance guided Fracture Rehablitation Method (PERFoRM) protocol.
Conditions studied
- Fracture of Proximal End of Humerus — all drugs for Fracture of Proximal End of Humerus →
- Fracture of Distal End of Radius — all drugs for Fracture of Distal End of Radius →
- Upper Extremity Fracture — all drugs for Upper Extremity Fracture →
- Upper Limb Fracture — all drugs for Upper Limb Fracture →
Sponsor
Zuyderland Medisch Centrum — full company profile →
Who can join
Adults 18 to 70, any sex, with Fracture of Proximal End of Humerus or Fracture of Distal End of Radius. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05390463 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zuyderland Medisch Centrum
- Last refreshed: 26 July 2024
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