NCT06294002

Brief Summary

Background: Postural stability (PS) is a vital function that helps maintain equilibrium during standing still, locomotion, and any activities requiring high balance performance. Under static and dynamic conditions, PS is a fundamental factor for the quality of movement in everyday activities or sports. PS and adaptive ability are required in sports due to the interactions between the sensory and motor systems, which regulate postural adjustments by processing information from the visual, vestibular, and somatosensory systems, as reported by previous studies. The interest in using different exercises and protocols for improving PS in sports and physiotherapy has grown in the last few decades. Experts have proposed various training modalities to increase neuromuscular stability, balance, postural control, and general stability. Dynamic Neuromuscular Stabilization (DNS) is a complex of correction exercises with a neuromuscular approach based on improving breathing, fundamental movements, and principles of developmental kinesiology. Whole body vibration training (WBV) is a neuromuscular training approach that has recently become very popular among researchers and practitioners in health and sport. It is usually used as an additional method in a conventional training routine. Designing the training program to achieve the optimal benefits for PS in healthy young adults is important in general personal health management. Although different training protocols have improved PS and general stability in everyday activities, there is still considerable debate regarding the optimal exercise modalities within an exercise program. Aim: The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation (DNS), whole-body vibration (WBV), and a combination of DNS and WBV (MIX) training modalities on postural stability (PS) in healthy recreation participants. Method and materials: 180 gender-balanced groups were divided into four groups, MIX, DNS, VIBRO and CONTROL and underwent two months of treatment. The single and double-leg Center of Force (COF) parameters were collected on the Forceplate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

5 days

First QC Date

February 20, 2024

Last Update Submit

March 4, 2024

Conditions

Keywords

postural controlexercisevibration trainingbalanceneuromuscular adaptation

Outcome Measures

Primary Outcomes (8)

  • Double-leg static postural stability sway area

    Double leg static postural stability sway area was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, featuring 4096 sensors and a scanning rate of up to 300 Hz. Participants completed single and double-leg tasks, each lasting 30 seconds with three trials and a two-minute break between each. During the double-leg stance, they were instructed to maintain a still, upright posture, standing comfortably with feet shoulder-width apart, barefoot, eyes open, and fixed on a cross 5 meters away at eye level on a blackboard. Arms were kept by their sides. Measurement began after a 10-second preparation period to avoid transient effects. Double-leg static postural stability sway area is analyzed in square centimeters.

    2 months

  • Double-leg static postural stability center of force traveled way

    Double leg static postural stability center of force traveled way was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, featuring 4096 sensors and a scanning rate of up to 300 Hz. Participants completed single and double-leg tasks, each lasting 30 seconds with three trials and a two-minute break between each. During the double-leg stance, they were instructed to maintain a still, upright posture, standing comfortably with feet shoulder-width apart, barefoot, eyes open, and fixed on a cross 5 meters away at eye level on a blackboard. Arms were kept by their sides. Measurement began after a 10-second preparation period to avoid transient effects. Double-leg static postural stability center of force traveled way is analyzed in millimeters.

    2 months

  • Double-leg static postural stability medio-lateral displacement

    Double leg static postural stability medio-lateral displacement was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, featuring 4096 sensors and a scanning rate of up to 300 Hz. Participants completed single and double-leg tasks, each lasting 30 seconds with three trials and a two-minute break between each. During the double-leg stance, they were instructed to maintain a still, upright posture, standing comfortably with feet shoulder-width apart, barefoot, eyes open, and fixed on a cross 5 meters away at eye level on a blackboard. Arms were kept by their sides. Measurement began after a 10-second preparation period to avoid transient effects. Double-leg static postural stability medio-lateral displacement is analyzed in millimeters.

    2 months

  • Double-leg static postural stability anterior-posterior displacement

    Double leg static postural stability anterior-posterior displacement was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, featuring 4096 sensors and a scanning rate of up to 300 Hz. Participants completed single and double-leg tasks, each lasting 30 seconds with three trials and a two-minute break between each. During the double-leg stance, they were instructed to maintain a still, upright posture, standing comfortably with feet shoulder-width apart, barefoot, eyes open, and fixed on a cross 5 meters away at eye level on a blackboard. Arms were kept by their sides. Measurement began after a 10-second preparation period to avoid transient effects. Double-leg static postural stability anterior-posterior displacement is analyzed in millimeters.

    2 months

  • Single-leg static postural stability sway area

    Single leg static postural stability sway area was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, equipped with 4096 sensors and a scanning rate of up to 300 Hz. During the single-limb stance test, participants balanced on one foot, aligning it forward with reference lines in the frontal and sagittal planes. The swinging leg was flexed at the hip and knee to about 90 degrees, while arms hung naturally at their sides. Participants were instructed to maintain a steady posture, focusing on a point 65 centimeters away on the wall. The order of testing between legs was randomized. Measurement began after a 5-second preparation period. Single-leg static postural stability sway area is analyzed in square centimeters..

    2 months

  • Single-leg static postural stability center of force traveled way

    Single leg static postural stability center of force traveled way was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, equipped with 4096 sensors and a scanning rate of up to 300 Hz. During the single-limb stance test, participants balanced on one foot, aligning it forward with reference lines in the frontal and sagittal planes. The swinging leg was flexed at the hip and knee to about 90 degrees, while arms hung naturally at their sides. Participants were instructed to maintain a steady posture, focusing on a point 65 centimeters away on the wall. The order of testing between legs was randomized. Measurement began after a 5-second preparation period. Single-leg static postural stability center of force traveled way is analyzed in millimeters.

    2 months

  • Single-leg static postural stability anterior-posterior displacement

    Single leg static postural stability anterior-posterior displacement was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, equipped with 4096 sensors and a scanning rate of up to 300 Hz. During the single-limb stance test, participants balanced on one foot, aligning it forward with reference lines in the frontal and sagittal planes. The swinging leg was flexed at the hip and knee to about 90 degrees, while arms hung naturally at their sides. Participants were instructed to maintain a steady posture, focusing on a point 65 centimeters away on the wall. The order of testing between legs was randomized. Measurement began after a 5-second preparation period. Single-leg static postural stability anterior-posterior displacement is analyzed in millimeters.

    2 months

  • Single-leg static postural stability medio-lateral displacement

    Single leg static postural stability medio-lateral displacement was evaluated using a 0.5 m Footscan® plate from RSscan International, Belgium, equipped with 4096 sensors and a scanning rate of up to 300 Hz. During the single-limb stance test, participants balanced on one foot, aligning it forward with reference lines in the frontal and sagittal planes. The swinging leg was flexed at the hip and knee to about 90 degrees, while arms hung naturally at their sides. Participants were instructed to maintain a steady posture, focusing on a point 65 centimeters away on the wall. The order of testing between legs was randomized. Measurement began after a 5-second preparation period. Single-leg static postural stability medio-lateral displacement is analyzed in millimeters.

    2 months

Secondary Outcomes (6)

  • Sex

    2 months

  • Date of birth

    2 months

  • Weight

    2 months

  • Height

    2 months

  • Body Mass Index (BMI)

    2 months

  • +1 more secondary outcomes

Study Arms (4)

Dynamic neuromuscular stabilization group (DNS)

EXPERIMENTAL

DNS - Dynamic neuromuscular stabilization intervention

Other: Dynamic neuromuscular stabilisation group

Whole body vibration group (VIBRO)

EXPERIMENTAL

VIBRO - Whole body vibration intervention

Other: Whole body vibration group

Dynamic neuromuscular stabilisation with whole body vibration group (MIX)

EXPERIMENTAL

MIX group - neuromuscular and whole body vibration intervention

Other: Dynamic neuromuscular stabilisation with whole body vibration group

Control group (CONTROL)

NO INTERVENTION

Control group - no intervention

Interventions

DNS group protocol involved 5 min a moderate intensity warm-up, 40 minutes of DNS movements according to the DNS approach, different diaphragmatic breathing, mobility and controlled movement exercises and 5 minutes of cool-down. Exercises gradually increased in complexity and difficulty level regarding DNS training principles. The participants were instructed to refrain from engaging in high-intensity anaerobic or anaerobic resistance training throughout the study period to prevent potential disruptions in the study results.

Dynamic neuromuscular stabilization group (DNS)

WBV was performed on the Power Plate Next Generation vibration platform (Power Plate North America, Chicago, IL). All training routines were approximately 50 minutes long, commencing with 5 minutes of moderate-intensity warm-up and concluding with a cool-down period. The program consisted of 8-10 static and dynamic exercises for PS that progressively increased in difficulty and complexity. During the training process, the frequency increased from 20 to 35 Hz in the last week of the experiment; the exercise duration was from 20 - 60 seconds (in the previous week), followed by 1-minute seated rest. Moreover, the complexity and difficulty of exercise increased over the experimental period. The resting period between sets was constant from the start to the end of the training process. During the experiment, the WBV intervention group performed three weekly training sessions.

Whole body vibration group (VIBRO)

The MIX group underwent a two-month training program consisting of three weekly sessions, including a 50-minute exercise program with a 5-minute warm-up and cool-down period. The training included 20 minutes of WBV and 20 minutes of DNS training, following previous research and training recommendations. VIBRO exercises were performed on the Power Plate Next Generation vibration platform, with 6-8 exercises for balance and PS. Participants were advised not to engage in high-intensity anaerobic or anaerobic resistance training. The training protocol was adapted from previous research.

Dynamic neuromuscular stabilisation with whole body vibration group (MIX)

Eligibility Criteria

Age21 Years - 26 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • history of neurological or musculoskeletal disorders;
  • clinical conditions that could impair balance (motor disorders, medical conditions like diabetes, heart disease, stroke, issues with vision, thyroid, nerves, or blood vessels).

You may not qualify if:

  • the absence of injuries in the past six months
  • the absence of other medical conditions, including COVID-19
  • no programmed physical activity in the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of sport and Physical Education, University of Novi Sad

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (1)

  • Marinkovic D, Macak D, Madic DM, Sporis G, Kuvacic D, Jasic D, Petric V, Spehnjak M, Projovic A, Gojkovic Z. Effect of Neuromuscular Training Program on Quality of Life After COVID-19 Lockdown Among Young Healthy Participants: A Randomized Controlled Trial. Front Psychol. 2022 Apr 12;13:844678. doi: 10.3389/fpsyg.2022.844678. eCollection 2022.

    PMID: 35496239BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dragan Marinkovic, MSc

    University of Novi Sad, Faculty of Sport and Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Investigator

Study Record Dates

First Submitted

February 20, 2024

First Posted

March 5, 2024

Study Start

February 15, 2022

Primary Completion

February 20, 2022

Study Completion

June 25, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations