Obesity & OverweightFoCo-WBVNCT07556198
Effects of Whole-Body Vibration With Foot Core Exercises: A Randomized Controlled Trial
A study testing Supervised Foot Core Exercise Training (No Vibration) and Whole-Body Vibration via DKN Technology Xg-10 Pro in people with Obesity & Overweight and Foot and Ankle Disorders, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Foot and Ankle Disorders
- What is being tested?
- Supervised Foot Core Exercise Training (No Vibration) and Whole-Body Vibration via DKN Technology Xg-10 Pro
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University Physiotherapy and Rehabilitation Practice & Research Center
Istanbul, Zeytinburnu, 3410
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Obesity & Overweight, Foot and Ankle Disorders
- Being tested
- Supervised Foot Core Exercise Training (No Vibration), Whole-Body Vibration via DKN Technology Xg-10 Pro
- Keywords
- Foot Core, Balance, Proprioseption, Whole Body Vibration
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Foot Core Exercise Training (No Vibration)Behavioural
24 face-to-face sessions over 8 weeks; physiotherapist-led progression in repetitions/active time; performed on DKN Xg-10 Pro with vibration off.
Whole-Body Vibration via DKN Technology Xg-10 ProDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group (EG) | Active comparator | 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. Receives: Behavioral: Supervised Foot Core Exercise Training (No Vibration); Device: Whole-Body Vibration via DKN Technology Xg-10 Pro |
| WBV-Combined Exercise Group (TEG) | Experimental | Identical supervised foot core exercise program performed with whole-body vibration during exercises; same schedule (3×/week, 8 weeks). Receives: Device: Whole-Body Vibration via DKN Technology Xg-10 Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of Stability (composite score, %)
Composite score from PROKIN computerized balance analysis system; higher scores reflect better voluntary control within stability boundaries; device-generated percentage scale. Safety Issue: No.
Measured: Baseline to Week 8
Secondary outcomes (4)
Single-Leg Balance test (device score)
PROKIN single-leg stance performance metric; device software scoring. Safety Issue: No.
Measured: Baseline to Week 8
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
PROKIN mCTSIB composite index; lower sway indicates better stability; device software
Measured: Baseline to Week 8
Ankle Strength (kg-force)
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.
Measured: Baseline to Week 8
Single-Leg Proprioception
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.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Single-Blind Trial with parallel allocation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirsad Alkan, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556198
- Sponsor's protocol ID
- KubraYikilmazTez 24-252
- Acronym
- FoCo-WBV
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07556198
- Acronym / sponsor ID
- FoCo-WBV / KubraYikilmazTez 24-252
- Conditions
- Obesity & Overweight, Foot and Ankle Disorders
- Keywords
- Foot Core, Balance, Proprioseption, Whole Body Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Single-Blind Trial with parallel allocation
| Arm | Type | Receives |
|---|---|---|
| Exercise Group (EG) | Active comparator | Behavioral: Supervised Foot Core Exercise Training (No Vibration), Device: Whole-Body Vibration via DKN Technology Xg-10 ProProgressive 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. |
| WBV-Combined Exercise Group (TEG) | Experimental | Device: Whole-Body Vibration via DKN Technology Xg-10 ProIdentical supervised foot core exercise program performed with whole-body vibration during exercises; same schedule (3×/week, 8 weeks). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Age 18-35 years; BMI 25.0-39.9 kg/m².
Key exclusion criteria (7 listed)
- Any medical history requiring regular physician follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised 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. | Behavioural | Exercise Group (EG) |
| Whole-Body Vibration via DKN Technology Xg-10 ProTri-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). | Device | Exercise Group (EG), WBV-Combined Exercise Group (TEG) |
Primary outcome
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.
4 secondary outcomes
Single-Leg Balance test (device score)
Time frame: Baseline to Week 8
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time frame: Baseline to Week 8
Ankle Strength (kg-force)
Time frame: Baseline to Week 8
Single-Leg Proprioception
Time frame: Baseline to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Foot Core Exercise Training (No Vibration) and Whole-Body Vibration via DKN Technology Xg-10 Pro in people with Obesity & Overweight and Foot and Ankle Disorders, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limits of Stability (composite score, %) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.