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Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture

U

Universidad Catolica de Temuco

Status

Begins enrollment this month

Conditions

Distal Radius Fractures
Wrist Fractures

Treatments

Other: Unilateral mobility exercises
Other: Unilateral high-intensity strength exercise
Other: Standard rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06698367
RCT-EdCruzada2024

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

Standard rehabilitation plus unilateral high-intensity strength exercise
Experimental group
Description:
Participants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation.
Treatment:
Other: Standard rehabilitation
Other: Unilateral high-intensity strength exercise
Standard rehabilitation plus unilateral mobility exercises
Active Comparator group
Description:
Participants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation
Treatment:
Other: Standard rehabilitation
Other: Unilateral mobility exercises

Trial contacts and locations

1

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Central trial contact

Iván Cuyul Vásquez

Data sourced from clinicaltrials.gov

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