NCT07723456

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026May 2027

First Submitted

Initial submission to the registry

July 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 15, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

Distal Radius FractureWhole Body VibrationProprioceptionSensorimotor FunctionWrist RehabilitationRandomized Controlled TrialConservative Treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline, Week 4, and Week 8

  • Numeric Pain Rating Scale (NPRS)

    Baseline, Week 4, and Week 8

  • Wrist Joint Position Sense (JPS)

    Baseline, Week 4, and Week 8

  • Grip Strength

    Baseline, Week 4, and Week 8

  • Wrist Range of Motion

    Baseline, Week 4, and Week 8

  • +1 more secondary outcomes

Study Arms (2)

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.

Device: Whole-Body Vibration TherapyOther: 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.

Other: Conventional Rehabilitation Exercise Program

Interventions

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.

Whole-Body Vibration + Conventional Rehabilitation

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.

Conventional RehabilitationWhole-Body Vibration + Conventional Rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by an independent physiotherapist who is blinded to group allocation. Participants and treating therapists cannot be blinded due to the nature of the intervention (whole-body vibration training).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 23, 2026

Study Start

July 25, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

May 25, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07