Early Mobilisation of the Distal Radius Fracture
1 other identifier
observational
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedStudy Start
First participant enrolled
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedSeptember 3, 2025
August 1, 2025
7 months
February 3, 2024
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
Grip strength
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
1 day
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
Study Arms (1)
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.
Interventions
Compared to nonoperated limb, after 6 months of early rehabilitation.
Eligibility Criteria
Patients with a distal radius fracture DRF resulting from injury
You may qualify if:
- age range 18-60 years
- distal radius fracture
- ORIF procedure
- hand stabilisation plate (Medartis)
You may not qualify if:
- delayed rehabilitation protocol
- algodystrophy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, 01-494, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 3, 2024
First Posted
February 14, 2024
Study Start
March 4, 2024
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share