Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture
NCT ID: NCT06698367
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2025-01-31
2027-08-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.
* Fracture treated surgically.
Exclusion Criteria
* 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.
30 Years
50 Years
ALL
No
Sponsors
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Universidad Catolica de Temuco
OTHER
Responsible Party
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Iván Alejandro Cuyul Vásquez
Principal Investigator
Locations
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Red Salud
Temuco, Temuco, Chile
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCT-EdCruzada2024
Identifier Type: -
Identifier Source: org_study_id