NCT06258928

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. 1.Significantly faster recovery of independence from daily activities by the patient.
  2. 2.For economic reasons, patients often expect to return to work as soon as possible.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

February 3, 2024

Last Update Submit

August 26, 2025

Conditions

Keywords

distal radius fractureearly therapyexercise therapy

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.

Diagnostic Test: Functional examination

Interventions

Functional examinationDIAGNOSTIC_TEST

Compared to nonoperated limb, after 6 months of early rehabilitation.

patients with a distal radius fracture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

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

Locations