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Effect of Whole Body Vibration on Rehabilitation in Distal Radius Fractures (WBV-DRF)

22 de julho de 2026 atualizado por: Tugba Civi Karaaslan, Istanbul University

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

66

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Patient-Rated Wrist Evaluation (PRWE) Score
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

25 de julho de 2026

Conclusão Primária (Estimado)

25 de agosto de 2026

Conclusão do estudo (Estimado)

25 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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