Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard rehabilitation, Unilateral high-intensity strength exercise, Unilateral mobility exercises.
- Who it may be relevant to
- Registry conditions: Wrist Fractures, Distal Radius Fractures. Basic parameters: 30 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Handgrip strength [Time frame: 0, 6 and 12 weeks]
- Manual dexterity [Time frame: 0, 6 and 12 weeks]
Secondary outcome measures (7)
- Active range motion [Time frame: 0, 6 and 12 weeks]
- Pain intensity [Time frame: 0, 6 and 12 weeks]
- Forearm circumference [Time frame: 0, 6 and 12 weeks]
- Maximum voluntary isometric strength. [Time frame: 0, 6 and 12 weeks]
- Self-reported upper limb function. [Time frame: 0, 6 and 12 weeks]
- Self-reported wrist function [Time frame: 0, 6 and 12 weeks]
- Health-related quality of life [Time frame: 0, 6 and 12]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Chile · 1 center
- Red Salud — Temuco
Identifiers
NCT: NCT06698367 · RCT-EdCruzada2024