Effect of Whole Body Vibration on Rehabilitation in Distal Radius Fractures (WBV-DRF)
Effect Of Whole Body Vibration On Functional And Sensorimotor Recovery In Conservatively Treated Distal Radius Fractures: A Randomized Controlled Trial
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Whole-Body Vibration + Conventional Rehabilitation
Participants assigned to this arm will receive conventional rehabilitation combined with whole-body vibration therapy three times per week for 8 weeks.
|
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.
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.
|
|
有源比较器：Conventional Rehabilitation
Participants assigned to this arm will receive the same conventional rehabilitation program without whole-body vibration therapy for 8 weeks.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-Rated Wrist Evaluation (PRWE) Score
大体时间：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.
|
From baseline to Week 8 (assessed at baseline, Week 4, and Week 8)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
大体时间：Baseline, Week 4, and Week 8
|
Upper extremity disability and functional status will be assessed using the QuickDASH questionnaire.
Scores range from 0 to 100, with lower scores indicating better upper extremity function.
|
Baseline, Week 4, and Week 8
|
|
Numeric Pain Rating Scale (NPRS)
大体时间：Baseline, Week 4, and Week 8
|
Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Lower scores indicate less pain.
|
Baseline, Week 4, and Week 8
|
|
Wrist Joint Position Sense (JPS)
大体时间：Baseline, Week 4, and Week 8
|
Wrist proprioception will be assessed using a joint position sense (JPS) test by measuring the absolute angular error between the target position and the reproduced position.
Lower values indicate better proprioceptive accuracy.
|
Baseline, Week 4, and Week 8
|
|
Grip Strength
大体时间：Baseline, Week 4, and Week 8
|
Grip strength will be measured using a calibrated hand dynamometer.
The average of three trials will be recorded, with higher values indicating greater grip strength.
|
Baseline, Week 4, and Week 8
|
|
Wrist Range of Motion
大体时间：Baseline, Week 4, and Week 8
|
Wrist and forearm range of motion will be measured using a goniometer.
Higher angular values indicate greater joint mobility.
|
Baseline, Week 4, and Week 8
|
|
Nine-Hole Peg Test
大体时间：Baseline, Week 4, and Week 8
|
Fine motor dexterity will be evaluated using the Nine-Hole Peg Test.
The time required to complete the test will be recorded in seconds, with shorter completion times indicating better hand dexterity.
|
Baseline, Week 4, and Week 8
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.