Foot and Ankle Disorders, Obesity & Overweight
Conditions
Keywords
Foot Core, Balance, Proprioseption, Whole Body Vibration
Brief summary
This randomized, single-blind clinical trial investigates whether adding whole-body vibration (WBV) to a supervised foot core exercise program improves ankle muscle strength, balance, and proprioception in overweight and obese young adults (BMI 25.0-39.9 kg/m²). Participants attended 24 face-to-face sessions over 8 weeks (3×/week) under physiotherapist supervision. Outcomes included isometric inversion/eversion strength (hand-held dynamometry) and instrumented balance/proprioception tests (Limits of Stability, mCTSIB, single-leg balance, single-leg proprioception) recorded by a computerized balance analysis system.
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.
Interventions
BEHAVIORALSupervised Foot Core Exercise Training (No Vibration)
24 face-to-face sessions over 8 weeks; physiotherapist-led progression in repetitions/active time; performed on DKN Xg-10 Pro with vibration off.
DEVICEWhole-Body Vibration via DKN Technology Xg-10 Pro
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).
Sponsors
Istinye University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single (Participant). Masking was applied to participants; groups were scheduled to avoid contact.
Intervention model description
Randomized Controlled Single-Blind Trial with parallel allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limits of Stability (composite score, %) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single-Leg Balance test (device score) | Baseline to Week 8 | PROKIN single-leg stance performance metric; device software scoring. Safety Issue: No. |
| Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) | Baseline to Week 8 | PROKIN mCTSIB composite index; lower sway indicates better stability; device software |
| Ankle Strength (kg-force) | 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. |
| Single-Leg Proprioception | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed