Feasibility of the PERformance Guided Fracture Rehablitation Method-protocol

NCT05390463 | Completed

• 1 other identifier: Z2021143
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fracture of Proximal End of Humerus; Fracture of Distal End of Radius; Upper Extremity Fracture; Upper Limb Fracture

Keywords

Fracture; Upper extremity; Radius; Humerus; Surgery; Rehabilitation; Surgical fixation; Protocol

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• 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 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 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 general health status.

  Change between immediate phase (0-2 weeks) post-surgery, 3 months post-surgery, 6 months post surgery.

Study Arms (1)

PERFoRM

Patients with surgically treated peri-articular fractures of the upper extremity (proximal humerus and distal radius fractures) undergoing treatment within the MDTU (Multi Disciplinary Trauma Unit) of the Zuyderland MC in Heerlen are included in this study.

Other: PERformance guided Fracture Rehablitation Method (PERFoRM) protocol.

Interventions

PERformance guided Fracture Rehablitation Method (PERFoRM) protocol. OTHER

A structured rehabilitation protocol for surgically treated peri-articular fractures of the upper extremity (proximal humerus and distal radius fractures).

PERFoRM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population: Patients with surgically treated peri-articular fractures of the upper extremity (proximal humerus and distal radius fractures) treated within the MDTU (Multi Disciplinary Trauma Unit) of the Zuyderland MC in Heerlen are included in this study.

You may not qualify if:

• 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)
• Multiple fractures to 1 limb
• Pathological fractures
• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, Netherlands

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• MPM Dremmen, MD

  Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 25, 2022
• Study Start: April 24, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)