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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Distal Radius Fractures; Wrist Fractures
• Intervention / Treatment: Other: Standard rehabilitation; Other: Unilateral high-intensity strength exercise; Other: Unilateral mobility exercises

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iván Cuyul Vásquez; Phone Number: 56990914987; Email: ivancuyul@gmail.com

Study Locations

• Chile
  • Temuco, Chile
    • Red Salud
    • Contact: Iván Cuyul Vásquez; Phone Number: 56990914987; Email: ivancuyul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard rehabilitation plus unilateral high-intensity strength exercise; Participants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation.	Other: Standard rehabilitation; Protocol based on the best available evidence and to be used in all participants in both groups. The standard rehabilitation protocol will consist of three postoperative phases: Mobilization (0 to 4 weeks), Strengthening (4 to 8 weeks) and Functional phase (8 to 12 weeks). Sessions will be held 3 times a week for 12 weeks. Each session will last 1 hour and will consist of different modalities of therapeutic exercise and cryotherapy.; Other: Unilateral high-intensity strength exercise; Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an eccentric exercise for the pronosupinator muscles with a dumbbell with adjustable weights. The training will start with an intensity of 60% of 1RM, until reaching 80% 1RM.
Active Comparator: Standard rehabilitation plus unilateral mobility exercises; Participants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation	Other: Standard rehabilitation; Protocol based on the best available evidence and to be used in all participants in both groups. The standard rehabilitation protocol will consist of three postoperative phases: Mobilization (0 to 4 weeks), Strengthening (4 to 8 weeks) and Functional phase (8 to 12 weeks). Sessions will be held 3 times a week for 12 weeks. Each session will last 1 hour and will consist of different modalities of therapeutic exercise and cryotherapy.; Other: Unilateral mobility exercises; Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an active mobility exercise for the pronation-supination muscles using a plastic rod.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Jamar grip dynamometer (kilos)	0, 6 and 12 weeks
Manual dexterity	Functional Dexterity Test (Seconds)	0, 6 and 12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, anxiety and stress	Depression, Anxiety and Stress Scale (0-63 points)	0 week
Treatment expectations	Treatment Expectation Questionnaire (0-10 points)	0 week
Physical activity	International Physical Activity Questionnaire (Categorical Score: Low, Moderate. High)	0 and 12 weeks

Collaborators and Investigators

• Sponsor: Universidad Catolica de Temuco

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Distal radius fracture; Cross-education
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: RCT-EdCruzada2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No