- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556198
Effects of Whole-Body Vibration With Foot Core Exercises: A Randomized Controlled Trial (FoCo-WBV)
Effects of Whole-Body Vibration Combined With Foot Core Exercise Training on Muscle Strength, Balance, and Proprioception in Overweight and Obese Young Adults: A Randomized Controlled Single-Blind Trial
Study Overview
Status
Conditions
Detailed Description
Design: randomized controlled, single-blind, parallel-group trial conducted at İstinye University Physiotherapy and Rehabilitation Practice & Research Center. Eligible adults (18-35 years; BMI 25-39.9 kg/m²) able to stand barefoot ≥15 s single-leg and perform 5 repetitions of 60° knee-flexion squats without rest were enrolled. Stratified randomization (sex, BMI) with computer sequence (Research Randomizer) and sealed opaque envelopes allocated participants to: (1) Exercise Group (EG): progressive foot core exercises performed on a vibration platform with vibration OFF; (2) WBV-Combined Exercise Group (TEG): identical exercises WITH synchronous whole-body vibration (20-50 Hz; 15-60 s bouts) using a DKN Technology Xg-10 Pro device. Both groups completed 24 supervised sessions across 8 weeks (3×/week). A standardized warm-up/self-massage of the foot/ankle preceded exercises; progression targeted repetitions, active time, and (in TEG) vibration frequency.
Assessments were performed pre- and post-intervention in fixed order with rest intervals. Ankle inversion/eversion strength was measured using a J-Tech Commander Echo digital handheld dynamometer (kg-force). Balance and proprioception were quantified on the PROKIN computerized system (Limits of Stability; mCTSIB; single-leg balance; single-leg proprioception metrics including trunk total standard deviation and mean tracking error).
Statistical plan: normality by Shapiro-Wilk; parametric tests for normally distributed variables (paired t-test within groups; independent t-test between groups), Mann-Whitney U for non-normal age, chi-square for categorical variables; Cohen's d for effect size where within-group change was significant. Analyses in IBM SPSS 25.0. Sample size was estimated a priori for large effect (d=0.8), α=0.05, power=0.80 (planned n=26; 13/group). Post-hoc power for Limits of Stability change in TEG yielded d=0.96, power=0.87. No funding; no conflicts declared.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zeytinburnu
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Istanbul, Zeytinburnu, Turkey (Türkiye), 3410
- Istinye University Physiotherapy and Rehabilitation Practice & Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Age 18-35 years; BMI 25.0-39.9 kg/m².
- Ability to stand barefoot on a firm surface ≥15 seconds single-leg (one attempt).
- Ability to perform 5 repetitions of 60° knee-flexion squat without needing rest.
- Turkish language proficiency for written and verbal communication.
Exclusion Criteria:
Any medical history requiring regular physician follow-up.
- Musculoskeletal trauma within the past 12 months.
- Use within 48 h of medications affecting musculoskeletal performance.
- Prior surgery or residual deficits from previous trauma.
- Pregnancy or suspected pregnancy.
- Any reported contraindication to use of a vibration platform.
- During study: pain >3/10 on VAS; abnormal blood pressure responses during/after sessions; three consecutive absences; failure to meet progression criteria; incident illness/trauma; withdrawal request.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise Group (EG)
Progressive foot core exercise program performed on a vibration platform with vibration disabled; supervised 3×/week for 8 weeks (24 sessions).
Standardized warm-up/self-massage, then sequence including foot tapping, bilateral heel raises, arch raises with toe ab/adduction, and single-leg stance on BOSU; progression by repetitions and active time.
|
24 face-to-face sessions over 8 weeks; physiotherapist-led progression in repetitions/active time; performed on DKN Xg-10 Pro with vibration off.
Tri-directional vibration delivered during exercises at 20-50 Hz with 15-60 s stimulus durations per set, progressing across sessions; administered concurrently with the foot core tasks under physiotherapist supervision (total 24 sessions).
|
|
Experimental: WBV-Combined Exercise Group (TEG)
Identical supervised foot core exercise program performed with whole-body vibration during exercises; same schedule (3×/week, 8 weeks).
|
Tri-directional vibration delivered during exercises at 20-50 Hz with 15-60 s stimulus durations per set, progressing across sessions; administered concurrently with the foot core tasks under physiotherapist supervision (total 24 sessions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Limits of Stability (composite score, %)
Time Frame: Baseline to Week 8
|
Composite score from PROKIN computerized balance analysis system; higher scores reflect better voluntary control within stability boundaries; device-generated percentage scale.
Safety Issue: No.
|
Baseline to Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single-Leg Balance test (device score)
Time Frame: Baseline to Week 8
|
PROKIN single-leg stance performance metric; device software scoring.
Safety Issue: No.
|
Baseline to Week 8
|
|
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time Frame: Baseline to Week 8
|
PROKIN mCTSIB composite index; lower sway indicates better stability; device software
|
Baseline to Week 8
|
|
Ankle Strength (kg-force)
Time Frame: Baseline to Week 8
|
Maximal isometric eversion and inversion measured with J-Tech Commander Echo handheld dynamometer; each limb tested in standardized position; result recorded in kg-force.
Safety Issue: No.
|
Baseline to Week 8
|
|
Single-Leg Proprioception
Time Frame: Baseline to Week 8
|
ROKIN single-leg proprioception protocol; trunk sway variability (total SD) computed by device software; lower values reflect more stable proprioceptive control.PROKIN target-tracking error in single-leg proprioception task; lower is better.
Safety Issue: No.
|
Baseline to Week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KubraYikilmazTez 24-252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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