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Clinical Trials/NCT06698367
NCT06698367
Not yet recruiting
Not Applicable

Addition of Unilateral Training of the Uninjured Limb to Standard Rehabilitation on Grip Strength and Manual Dexterity of Patients with Surgically Treated Distal Radius Fracture.

Universidad Catolica de Temuco1 site in 1 country52 target enrollmentJanuary 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wrist Fractures
Sponsor
Universidad Catolica de Temuco
Enrollment
52
Locations
1
Primary Endpoint
Handgrip strength
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. It is presumed that the addition of unilateral upper limb training will significantly improve maximum grip strength and manual dexterity at the end of the intervention period compared to the group receiving only standard rehabilitation.

Patients who agree to participate in this research will be randomly assigned to a control group (standard rehabilitation with unilateral training with mobility exercises) or an experimental group (standard rehabilitation with unilateral high-intensity strength training). The duration of the postoperative intervention will be 12 weeks. The primary variables are maximum grip strength and manual dexterity. Secondary variables are wrist mobility, forearm circumference, maximum voluntary isometric strength, functionality and health-related quality of life. Results will be measured at 0, 6 and 12 weeks postoperative.

Registry
clinicaltrials.gov
Start Date
January 2025
End Date
August 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Iván Alejandro Cuyul Vásquez

Principal Investigator

Universidad Catolica de Temuco

Eligibility Criteria

Inclusion Criteria

  • Age between 30-50 years
  • Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.
  • Fracture treated surgically.

Exclusion Criteria

  • Patients with lesion of the triangular fibrocartilage.
  • Patients with distal radius fracture with consolidation disorders.
  • Patients with health conditions that cause pain or affect the motor skills of the upper limb (radiocarpal osteoarthritis, carpal tunnel syndrome, Quervain's tenosynovitis, neurodegenerative diseases, sequelae of stroke)
  • Patients with multi-site pain or chronic polyarticular diseases such as osteoarthritis or rheumatoid arthritis.
  • Unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow high-intensity physical exercise.
  • Patients who are taking nutritional supplements that interfere with the regulation of skeletal muscle strength and mass (example: whey protein, creatine, etc.)
  • Inability to understand, read and/or speak the Spanish language.

Outcomes

Primary Outcomes

Handgrip strength

Time Frame: 0, 6 and 12 weeks

Jamar grip dynamometer (kilos)

Manual dexterity

Time Frame: 0, 6 and 12 weeks

Functional Dexterity Test (Seconds)

Secondary Outcomes

  • Active range motion(0, 6 and 12 weeks)
  • Pain intensity(0, 6 and 12 weeks)
  • Forearm circumference(0, 6 and 12 weeks)
  • Maximum voluntary isometric strength.(0, 6 and 12 weeks)
  • Self-reported upper limb function.(0, 6 and 12 weeks)
  • Self-reported wrist function(0, 6 and 12 weeks)
  • Health-related quality of life(0, 6 and 12)

Study Sites (1)

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