Clinical trial NCT06698367: Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wrist Fractures
Distal Radius Fractures
Keywords: Distal radius fracture
Cross-education
Rehabilitation
Exercise
Lead sponsor: Universidad Catolica de Temuco
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Handgrip strength
timeFrame: 0, 6 and 12 weeks
measure: Manual dexterity
timeFrame: 0, 6 and 12 weeks
Secondary outcomes:
measure: Active range motion
timeFrame: 0, 6 and 12 weeks
measure: Pain intensity
timeFrame: 0, 6 and 12 weeks
measure: Forearm circumference
timeFrame: 0, 6 and 12 weeks
measure: Maximum voluntary isometric strength.
timeFrame: 0, 6 and 12 weeks
measure: Self-reported upper limb function.
timeFrame: 0, 6 and 12 weeks
measure: Self-reported wrist function
timeFrame: 0, 6 and 12 weeks
measure: Health-related quality of life
timeFrame: 0, 6 and 12
Other outcomes:
measure: Depression, anxiety and stress
timeFrame: 0 week
measure: Treatment expectations
timeFrame: 0 week
measure: Physical activity
timeFrame: 0 and 12 weeks
Locations:
city: Temuco
country: Chile
facility: Red Salud
Study officials:
References: