Distal Radius FractureWBV-DRFNCT07723456
Effect of Whole Body Vibration on Rehabilitation in Distal Radius Fractures
A study testing Whole-Body Vibration Therapy and Conventional Rehabilitation Exercise Program in people with Distal Radius Fracture, run by Istanbul University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Whole-Body Vibration Therapy and Conventional Rehabilitation Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2026to 25 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Active inflammatory or vascular disease affecting the upper extremity.
- Cognitive impairment preventing participation in the study.
- Inability to attend the rehabilitation program regularly.
About this study
Official title: 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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Whole-Body Vibration Therapy, Conventional Rehabilitation Exercise Program
- Keywords
- Distal Radius Fracture, Whole Body Vibration, Proprioception, Sensorimotor Function, Wrist Rehabilitation, Randomized Controlled Trial, Conservative Treatment
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body Vibration TherapyDevice
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.
Conventional Rehabilitation Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Vibration + Conventional Rehabilitation | Experimental | Participants assigned to this arm will receive conventional rehabilitation combined with whole-body vibration therapy three times per week for 8 weeks. Receives: Device: Whole-Body Vibration Therapy; Other: Conventional Rehabilitation Exercise Program |
| Conventional Rehabilitation | Active comparator | Participants assigned to this arm will receive the same conventional rehabilitation program without whole-body vibration therapy for 8 weeks. Receives: Other: Conventional Rehabilitation Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Wrist Evaluation (PRWE) Score
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.
Measured: From baseline to Week 8 (assessed at baseline, Week 4, and Week 8)
Secondary outcomes (6)
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
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.
Measured: Baseline, Week 4, and Week 8
Numeric Pain Rating Scale (NPRS)
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.
Measured: Baseline, Week 4, and Week 8
Wrist Joint Position Sense (JPS)
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.
Measured: Baseline, Week 4, and Week 8
Grip Strength
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.
Measured: Baseline, Week 4, and Week 8
Wrist Range of Motion
Wrist and forearm range of motion will be measured using a goniometer. Higher angular values indicate greater joint mobility.
Measured: Baseline, Week 4, and Week 8
Nine-Hole Peg Test
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.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the experimental group (whole body vibration plus conventional rehabilitation) or the control group (conventional rehabilitation alone). Both groups will be followed in parallel throughout the 8-week intervention period and assessed at baseline, week 4, and week 8.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723456
- Sponsor's protocol ID
- 4801240324
- Acronym
- WBV-DRF
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Whole Body Vibration On Functional And Sensorimotor Recovery In Conservatively Treated Distal Radius Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07723456
- Acronym / sponsor ID
- WBV-DRF / 4801240324
- Conditions
- Distal Radius Fracture
- Keywords
- Distal Radius Fracture, Whole Body Vibration, Proprioception, Sensorimotor Function, Wrist Rehabilitation, Randomized Controlled Trial, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the experimental group (whole body vibration plus conventional rehabilitation) or the control group (conventional rehabilitation alone). Both groups will be followed in parallel throughout the 8-week intervention period and assessed at baseline, week 4, and week 8.
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Vibration + Conventional Rehabilitation | Experimental | Device: Whole-Body Vibration Therapy, Other: Conventional Rehabilitation Exercise ProgramParticipants assigned to this arm will receive conventional rehabilitation combined with whole-body vibration therapy three times per week for 8 weeks. |
| Conventional Rehabilitation | Active comparator | Other: Conventional Rehabilitation Exercise ProgramParticipants assigned to this arm will receive the same conventional rehabilitation program without whole-body vibration therapy for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body Vibration TherapyWhole-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. | Device | Whole-Body Vibration + Conventional Rehabilitation |
| Conventional Rehabilitation Exercise ProgramParticipants 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. | Other | Conventional Rehabilitation, Whole-Body Vibration + Conventional Rehabilitation |
Primary outcome
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.
6 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time frame: Baseline, Week 4, and Week 8
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, Week 4, and Week 8
Wrist Joint Position Sense (JPS)
Time frame: Baseline, Week 4, and Week 8
Grip Strength
Time frame: Baseline, Week 4, and Week 8
Wrist Range of Motion
Time frame: Baseline, Week 4, and Week 8
Nine-Hole Peg Test
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Vibration Therapy and Conventional Rehabilitation Exercise Program in people with Distal Radius Fracture, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (PRWE) Score (time frame: From baseline to Week 8 (assessed at baseline, Week 4, and Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.