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

Not Applicable

Not yet recruiting

• Conditions: Wrist Fractures; Distal Radius Fractures

• Registration Number: NCT06698367
• Lead Sponsor: Universidad Catolica de Temuco

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Study Start: 2025-01
• Primary Completion: 2026-12
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Manual dexterity	0, 6 and 12 weeks	Functional Dexterity Test (Seconds)
Handgrip strength	0, 6 and 12 weeks	Jamar grip dynamometer (kilos)

Secondary Outcome Measures

Name	Time	Method
Self-reported upper limb function.	0, 6 and 12 weeks	Quick Disabilities of Arm, Shoulder and Hand (0-100 points)
Self-reported wrist function	0, 6 and 12 weeks	Patient-Rated Wrist Evaluation (0-50 points)
Health-related quality of life	0, 6 and 12	Short Form-12 (0-100 points)
Forearm circumference	0, 6 and 12 weeks	Circumference (cm)
Maximum voluntary isometric strength.	0, 6 and 12 weeks	Progressor 300, Tindeq, Norway (Kilos)
Active range motion	0, 6 and 12 weeks	Wrist and forearm: Extension, flexion, pronation and supination (degree)
Pain intensity	0, 6 and 12 weeks	Visual Analogue Scale (0-10 centimeters)

Trial Locations

Locations (1)

Red Salud; 🇨🇱 Temuco, Chile