Effect of Whole Body Vibration on Rehabilitation in Distal Radius Fractures

Официальное название

Effect Of Whole Body Vibration On Functional And Sensorimotor Recovery In Conservatively Treated Distal Radius Fractures: A Randomized Controlled Trial

Обзор

This study is a randomized controlled clinical trial designed to evaluate the effects of whole body vibration (WBV) added to conventional rehabilitation on functional and sensorimotor recovery in patients with conservatively treated distal radius fractures. Following immobilization, patients often experience pain, reduced range of motion, decreased muscle strength, and impaired proprioception, which negatively affect functional recovery. WBV is thought to enhance neuromuscular activation and improve proprioceptive input, thereby contributing to functional performance. Participants will be randomly assigned into two groups; the experimental group will receive WBV in addition to conventional rehabilitation three times per week for eight weeks, while the control group will receive only conventional rehabilitation. Assessments will be conducted at baseline, week 4, and week 8. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE), while secondary outcomes include QuickDASH, Numeric Pain Rating Scale (NPRS), joint position sense, grip strength, range of motion, and fine motor skills.

Подробное описание

This study is designed as a single-center, randomized controlled clinical trial to evaluate the effects of whole body vibration (WBV) added to conventional rehabilitation on functional and sensorimotor recovery in patients with conservatively treated distal radius fractures. Distal radius fractures are among the most common upper extremity injuries and may lead to pain, reduced range of motion, decreased muscle strength, and impaired proprioception following immobilization. These impairments can delay functional recovery and negatively affect the return to daily activities.

Whole body vibration is considered a complementary rehabilitation approach that can enhance neuromuscular activation through mechanical stimulation and may improve proprioceptive input via muscle spindle activation and afferent pathways. Therefore, WBV is thought to contribute to improvements in coordination, muscle performance, and overall functional outcomes.

A total of 66 participants who meet the inclusion criteria will be randomly assigned into two groups. The experimental group will receive WBV in addition to a conventional rehabilitation program, while the control group will receive only the conventional rehabilitation program. Both groups will undergo treatment three times per week for eight weeks, with each session lasting approximately 45-60 minutes.

The WBV intervention will be applied using a vibration platform at a frequency of 30-35 Hz and a low amplitude (2 mm). The intervention protocol will be progressively increased over time, and exercises will be performed in two positions: an upper extremity weight-bearing position and a semi-squat position.

All assessments will be conducted at baseline, week 4, and week 8 by a blinded assessor. The primary outcome measure will be the Patient-Rated Wrist Evaluation (PRWE). Secondary outcome measures will include the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH), Numeric Pain Rating Scale (NPRS), joint position sense (JPS), grip strength, range of motion, and fine motor skills assessed by the Nine-Hole Peg Test.

The findings of this study are expected to provide evidence regarding the clinical effectiveness of WBV in distal radius fracture rehabilitation and contribute to the development of sensorimotor-oriented rehabilitation strategies.

Вмешательства

• Устройство Whole-Body Vibration Therapy
  Whole-body vibration therapy will be administered using a Power Plate device at a frequency of 35 Hz and an amplitude of 2 mm, three sessions per week for 8 weeks, in addition to a standardized conventional rehabilitation program.
• Другое Conventional Rehabilitation Exercise Program
  Participants will receive a standardized conventional rehabilitation program including range of motion exercises, strengthening exercises, proprioceptive training, functional activities, and patient education three times per week for 8 weeks.

Первичные конечные точки

• Patient-Rated Wrist Evaluation (PRWE) Score [Срок оценки: From baseline to Week 8 (assessed at baseline, Week 4, and Week 8)]

Вторичные конечные точки (6)

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score [Срок оценки: Baseline, Week 4, and Week 8]
• Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline, Week 4, and Week 8]
• Wrist Joint Position Sense (JPS) [Срок оценки: Baseline, Week 4, and Week 8]
• Grip Strength [Срок оценки: Baseline, Week 4, and Week 8]
• Wrist Range of Motion [Срок оценки: Baseline, Week 4, and Week 8]
• Nine-Hole Peg Test [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

• Adults aged 18 to 65 years.
• Unilateral distal radius fracture treated conservatively with cast or splint.
• Completion of the immobilization period with radiologically confirmed stable callus formation.
• Referred for physiotherapy after conservative treatment.
• Able to understand study procedures and provide written informed consent.
• Initiation of rehabilitation within 72 hours after cast removal.

Критерии исключения

• Previous surgery or severe trauma to the affected upper extremity.
• Open wound or active infection at the fracture site.
• Peripheral neuropathy or severe neurological disorders.
• Vestibular disorders or conditions contraindicating whole-body vibration therapy.
• Pregnancy.
• Severe osteoporosis.
• Active inflammatory or vascular disease affecting the upper extremity.
• Cognitive impairment preventing participation in the study.
• Inability to attend the rehabilitation program regularly.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07723456 · 4801240324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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