NCT07556198

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 22, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Foot CoreBalanceProprioseptionWhole Body Vibration

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to Week 8

Secondary Outcomes (4)

  • Single-Leg Balance test (device score)

    Baseline to Week 8

  • Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)

    Baseline to Week 8

  • Ankle Strength (kg-force)

    Baseline to Week 8

  • Single-Leg Proprioception

    Baseline to Week 8

Study Arms (2)

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.

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).

Device: Whole-Body Vibration via DKN Technology Xg-10 Pro

Interventions

24 face-to-face sessions over 8 weeks; physiotherapist-led progression in repetitions/active time; performed on DKN Xg-10 Pro with vibration off.

Exercise Group (EG)

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).

Exercise Group (EG)WBV-Combined Exercise Group (TEG)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Physiotherapy and Rehabilitation Practice & Research Center

Istanbul, Zeytinburnu, 3410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant). Masking was applied to participants; groups were scheduled to avoid contact.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Single-Blind Trial with parallel allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst. prof.

Study Record Dates

First Submitted

April 22, 2026

First Posted

April 29, 2026

Study Start

February 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations