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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Aktywny komparator: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patient-Rated Wrist Evaluation (PRWE) Score
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 4801240324
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .