Upper Extremity Fracture Clinical Trial
— PERFoRMOfficial title:
Feasibility of the PERformance Guided Fracture Rehablitation Method (PERFoRM) Protocol for Periarticular Upper Extremity Fractures
Verified date | July 2023 |
Source | Zuyderland Medisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland Medisch Centrum | Heerlen |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of the PERFoRM-protocol at starting point of the study: qualitative assessment through standardized questionnaire. | Feasibility of the PERFoRM-protocol: qualitative assessment through standardized questionnaire (questionnaire composed by investigator). | at starting point of the study (before the first inclusion); at 0 months. | |
Primary | Feasibility of the PERFoRM-protocol at 6 months after the starting point of the study: qualitative assessment through standardized questionnaire. | Feasibility of the PERFoRM-protocol: qualitative assessment through standardized questionnaire (questionnaire composed by investigator). | 6 months after above-mentioned starting point of the study. | |
Secondary | Change of rate of disability of (affected) arm-shoulder-hand. | Measurement of change in rate of disability of (affected) arm-shoulder-hand, through (Quick-) DASH; Disability Arm Shoulder Hand - questionnaire.
Scoring: range 0-100. Score 0: no limitations in functioning. Score 100: high limitations in functioning. |
Change between immediate phase (0-2 weeks) post-surgery, 6 weeks post-surgery, 3 months post-surgery, 6 months post surgery. | |
Secondary | Change in handstrength of affected limb. | Measurement of change in handstrength of affected limb, through hand-held-dynamometer.
Reference table handstrength: Men: 0kg (lowest strength) - 64kg (highest strength); Women: 0kg (lowest strength) - 39kg (highest strength). |
Change between immediate phase (0-2 weeks) post-surgery, 6 weeks post-surgery, 3 months post-surgery, 6 months post surgery. | |
Secondary | Change in pain of affected limb. | Measurement of change in pain of affected limb, through Numeric Pain Rating Scale (NPRS).
Scoring: range 0-10. Score 0: no pain. Score 10: worst pain ever. |
Change between immediate phase (0-2 weeks) post-surgery, 6 weeks post-surgery, 3 months post-surgery, 6 months post surgery. | |
Secondary | Change in general health status. | Measurement of change in general health status, through Research and develop-36; general health status (RAND-36) - questionnaire.
Scoring: range 0-100. Higher scores present better general health status. |
Change between immediate phase (0-2 weeks) post-surgery, 3 months post-surgery, 6 months post surgery. |
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