Effect Of Whole Body Vibration On Functional And Sensorimotor Recovery In Conservatively Treated Distal Radius Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Patient-Rated Wrist Evaluation (PRWE) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments will be performed by an independent physiotherapist who is blinded to group allocation. Participants and treating therapists cannot be blinded due to the nature of the intervention (whole-body vibration training).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient-Rated Wrist Evaluation (PRWE) Score
时间窗: From baseline to Week 8 (assessed at baseline, Week 4, and Week 8)
The Patient-Rated Wrist Evaluation (PRWE) questionnaire will be used to assess wrist pain and function. Scores range from 0 to 100, with lower scores indicating better wrist function and less pain.
次要结局
- Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score(Baseline, Week 4, and Week 8)
- Numeric Pain Rating Scale (NPRS)(Baseline, Week 4, and Week 8)
- Wrist Joint Position Sense (JPS)(Baseline, Week 4, and Week 8)
- Grip Strength(Baseline, Week 4, and Week 8)
- Wrist Range of Motion(Baseline, Week 4, and Week 8)
- Nine-Hole Peg Test(Baseline, Week 4, and Week 8)
研究者
Tugba Civi Karaaslan
Assistant Professor
Istanbul University - Cerrahpasa