Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

22 de julio de 2026 actualizado 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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

66

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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 activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-Rated Wrist Evaluation (PRWE) Score
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

25 de julio de 2026

Finalización primaria (Estimado)

25 de agosto de 2026

Finalización del estudio (Estimado)

25 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de julio de 2026

Publicado por primera vez (Actual)

23 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir