Early Mobilisation of the Distal Radius Fracture

August 26, 2025 updated by: Magdalena Kolasińska, Józef Piłsudski University of Physical Education

Early Mobilisation of the Distal Radius Fracture Isokinetic and Functional Evaluation

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-494
        • Terapia Ręki Magda Kolasińska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with a distal radius fracture DRF resulting from injury

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • delayed rehabilitation protocol
  • algodystrophy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with a distal radius fracture
Functional examination included evaluating range of motion (ROM), grip strength, and isokinetic evaluation of force moments (Biodex) for wrist flexion, extension, forearm pronation, and forearm supination. Michigan's questionnaire and the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire were used to subjectively evaluate the effects of therapy.
Compared to nonoperated limb, after 6 months of early rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH -Disability of the Arm, Shoulder, and Hand
Time Frame: 1 day
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
ROM - range of motion
Time Frame: 1 day
Flexion, extension of the wrist, supination and pronation of the forearm using a 15 cm stainless steel Saehan finger goniometer
1 day
Grip strength
Time Frame: 1 day
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
1 day
Isokinetic evaluation
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Radius Fracture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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