- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07723456
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-Rated Wrist Evaluation (PRWE) Score
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4801240324
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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