Early Mobilisation of the Distal Radius Fracture

Secondary Prevention Clinical Trial

Official title:

Early Mobilisation of the Distal Radius Fracture Isokinetic and Functional Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258928
• Other study ID #: Radius Fracture
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Józef Pilsudski University of Physical Education
• Contact: Magdalena Kolasinska, Msc
• Phone: +48609219822
• Email: magdalena.kolasinska[@]awf.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this clinical trial is to demonstrate the effectiveness of early therapy in 14 patients with a distal radius fracture DRF resulting from injury, as the study group. Assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method (ORIF), compared to their nonoperated limb, after 6 months of early rehabilitation. The main questions it aims to answer are: 1. Significantly faster recovery of independence from daily activities by the patient. 2. For economic reasons, patients often expect to return to work as soon as possible. Participants will be subjected to functional examination to assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• age range 18-60 years
• distal radius fracture
• ORIF procedure
• hand stabilisation plate (Medartis)

Exclusion Criteria:

• delayed rehabilitation protocol
• algodystrophy

Related Conditions & MeSH terms

• Radius Fractures
• Secondary Prevention
• Wrist Fractures

Intervention

Diagnostic Test:
• Functional examination
Compared to nonoperated limb, after 6 months of early rehabilitation.

Locations

Country	Name	City	State
Poland	Terapia Reki Magda Kolasinska	Warszawa	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH -Disability of the Arm, Shoulder, and Hand	questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. Assess symptoms and the inability to perform certain activities based on health status.	1 day
Primary	ROM - range of motion	Flexion, extension of the wrist, supination and pronation of the forearm using a 15 cm stainless steel Saehan finger goniometer	1 day
Primary	Grip strength	Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength	1 day
Primary	Isokinetic evaluation	Isokinetic evaluation of force moments of the biceps and triceps, and the muscles responsible for supination and pronation of the forearm using the Biodex System 4 Pro (Biodex, USA) dynamometer.	1 day