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

NCT06698367 | Not Yet Recruiting

• 1 other identifier: RCT-EdCruzada2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrist Fractures; Distal Radius Fractures

Keywords

Distal radius fracture; Cross-education; Rehabilitation; Exercise

Outcome Measures

Primary Outcomes (2)

• Handgrip strength

  Jamar grip dynamometer (kilos)

  0, 6 and 12 weeks

• Manual dexterity

  Functional Dexterity Test (Seconds)

  0, 6 and 12 weeks

Secondary Outcomes (7)

• 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

Other Outcomes (3)

• Depression, anxiety and stress

  0 week

• Treatment expectations

  0 week

• Physical activity

  0 and 12 weeks

Study Arms (2)

Standard rehabilitation plus unilateral high-intensity strength exercise

EXPERIMENTAL

Participants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation.

Other: Standard rehabilitation; Other: Unilateral high-intensity strength exercise

Standard rehabilitation plus unilateral mobility exercises

ACTIVE COMPARATOR

Participants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation

Other: Standard rehabilitation; Other: Unilateral mobility exercises

Interventions

Standard rehabilitation OTHER

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.

Standard rehabilitation plus unilateral high-intensity strength exercise; Standard rehabilitation plus unilateral mobility exercises

Unilateral high-intensity strength exercise OTHER

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.

Standard rehabilitation plus unilateral high-intensity strength exercise

Unilateral mobility exercises OTHER

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.

Standard rehabilitation plus unilateral mobility exercises

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Catolica de Temuco: lead

Study Sites (1)

Red Salud

Temuco, Temuco, Chile

Location

MeSH Terms

Conditions

Wrist Fractures; Motor Activity

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Behavior

Central Study Contacts

Iván Cuyul Vásquez

CONTACT

56990914987; ivancuyul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)