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

22. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Whole-Body Vibration Therapy
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.
Andet: Conventional Rehabilitation Exercise 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.
Aktiv komparator: Conventional Rehabilitation
Participants assigned to this arm will receive the same conventional rehabilitation program without whole-body vibration therapy for 8 weeks.
Andet: Conventional Rehabilitation Exercise 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Rated Wrist Evaluation (PRWE) Score
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juli 2026

Primær færdiggørelse (Anslået)

25. august 2026

Studieafslutning (Anslået)

25. maj 2027

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

22. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4801240324

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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