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

Официальное название

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.

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Handgrip strength [Срок оценки: 0, 6 and 12 weeks]
• Manual dexterity [Срок оценки: 0, 6 and 12 weeks]

Вторичные конечные точки (7)

• Active range motion [Срок оценки: 0, 6 and 12 weeks]
• Pain intensity [Срок оценки: 0, 6 and 12 weeks]
• Forearm circumference [Срок оценки: 0, 6 and 12 weeks]
• Maximum voluntary isometric strength. [Срок оценки: 0, 6 and 12 weeks]
• Self-reported upper limb function. [Срок оценки: 0, 6 and 12 weeks]
• Self-reported wrist function [Срок оценки: 0, 6 and 12 weeks]
• Health-related quality of life [Срок оценки: 0, 6 and 12]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Red Salud — Temuco

Идентификаторы

NCT: NCT06698367 · RCT-EdCruzada2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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