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Postural StabilitySTABLEFITNCT06294002

Neuromuscular Training & Postural Stability

A study testing Dynamic neuromuscular stabilisation group, Whole body vibration group and Dynamic neuromuscular stabilisation with whole body vibration group in people with Postural Stability, run by University of Novi Sad at 1 site in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 26 yearsHealthy volunteers can take part
Conditions the study is for
Postural Stability
What is being tested?
Dynamic neuromuscular stabilisation group, Whole body vibration group and Dynamic neuromuscular stabilisation with whole body vibration group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSerbia
Study dates
15 Feb 2022to 25 Jun 2022
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 21 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Serbia1 site
  • Faculty of sport and Physical Education, University of Novi Sad

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

About this study

Official title: Effect of Different Neuromuscular Training Modalities on Postural Stability in Healthy Recreation People: A Randomised Controlled Trial

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.

Read the detailed description

Study design 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. The study presents an Interventional study to improve postural stability, and the main objective is prevention. The study model is parallel with four groups.

Participants The randomised, controlled interventional trial enrolled a gender-balanced group of 180 healthy young participants. The initial sample of respondents was recruited through an open online application that lasted two months (from 10.2.2022. to 10.4.2022.) (n=250), after which the first selection of respondents was started (n=230). Recruitment was completed after the optimal sample of subjects was filled (15.4.2022). The study sample was divided using stratified randomisation into the MIX group (n = 58), DNS group (n=57), VIBRO (n=57), and CONTROL group (n=58). At the end of the experimental program, the final sample was 180 (MIX=45; DNS=45; VIBRO=44; CONTROL=43). When stratifying, researchers use proportionate sampling to maintain the correct proportions of genders in every group. After explaining the experimental protocol, each subject provided written informed consent before participating in the study, per the Declaration of Helsinki and the Novi Sad University Human Research Ethics Committee guidelines (ethical approval number: 46-06-04/2020-1). The interventional program was conducted from 25.4.2022. to 25.6.2022. Ethics committee - commission for the implementation of scientific project research.

The exclusion criteria were:

  • 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).

The inclusion criteria for this study were:

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

Testing procedures The testing was conducted at the Faculty of Sport and Physical Education, University of Novi Sad, Serbia. All participants were tested in the morning before their training session in indoor environmental conditions (temperature: 18-21°C; relative humidity: 40-60%). Before starting a performance task, general information about the examinees was recorded, including gender, age, height, and mass. Participants were instructed to wear minimal clothing and remove all footwear for height and mass measurements. In addition, they were required to eat and drink sparingly and void their bladder/excrete as needed before presenting for assessment. A stadiometer (0.1 cm accuracy, SECA Instruments Ltd, Hamburg, Germany) is a secondary outcome for height and mass measurements. Initial testing was conducted on 20.4.2022 and final on 25.6.2022.

Static PS was assessed with a laboratory-grade 0.5 m Footscan® plate (RSscan International, Lammerdries, Belgium) with 4096 sensors and a scanning rate of up to 300 Hz. The subject performed an individual single and double-leg task with three trials, each lasting 30 seconds with a two-minute break between each trial. During the double-leg stance test, participants were instructed to maintain an upright posture as still as possible. They were asked to stand in their natural, comfortable position with their eyes open and fixed on a cross positioned at approximately eye level on a blackboard 5 meters away. Participants stood barefoot with their feet placed shoulder-width apart on a platform, and their arms were kept by their sides. Each participant was required to maintain this stable posture, and measurement started after 10 seconds (preparation period to avoid transient effects). During the single-limb stance test, participants were instructed to balance on one foot. This foot was positioned to point directly forward, aligning with reference lines in the frontal and sagittal planes. The swinging leg was flexed at the hip and knee joints to approximately 90 degrees while both arms hung naturally and relaxed at their sides. Participants were further instructed to maintain as steady a posture as possible, focusing their gaze straight ahead on a point situated 65 centimetres away on the wall. The order of testing between the left and right legs was randomised. Each participant was required to maintain this stable position, and measurement started after 5 seconds (preparation period to avoid transient effects).

Tests for static PS were the gold standard in measuring balance and were used to obtain biomechanical parameters of static PS. All measurements were performed in triplicate, and the mean score was retained for subsequent evaluations and analyses. The sequence of performing the balance tasks was randomised.

The software calculated the single and double-leg Sway Area (cm²), Center of Force (COF) travelled way (mm), Medio-Lateral (ML) displacement (mm), and Anterior-Posterior (AP) displacement (mm) as primary outcomes. As stated in previous research, the following protocol was chosen based on their varying difficulty and everyday use and is cited as reliable.

Interventions Dynamic neuromuscular stabilisation group (DNS) The DNS group's 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.

Whole body vibration group (VIBRO) 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. The participants were advised to avoid participating in high-intensity anaerobic or anaerobic resistance training during the study to ensure that it would not interfere with the study's outcomes-no changes to trial outcomes after the trial commenced. Principles and basic procedures were adapted from previous research.

Dynamic neuromuscular stabilisation with whole body vibration group (MIX) During the two months, participants in the MIX group performed training consisting of 3 weekly sessions. The protocol consisted of a 50-minute exercise program with a 5-minute moderate-intensity warm-up and cool-down period per training session. The structural core of training included 20 minutes of WBV and 20 minutes of DNS training. Both protocols followed the previous research and training recommendations and were performed with less time and sets. Exercises with VIBRO were performed on the Power Plate Next Generation vibration platform (Power Plate North America, Chicago, IL). The program consisted of 6-8 exercises (static and dynamic) for balance and PS. Exercise progressively increases by the level of difficulty. During the training process, the frequency was also increased from 20 to 35 Hz in the last week of the experiment; the duration of exercise from 20 - 60 seconds (in the previous week), followed by 1-minute seated rest. The resting period between sets was constant from the start to the end of the training process. To prevent any interference with the study's results, participants were recommended to abstain from engaging in high-intensity anaerobic or anaerobic resistance training throughout the study. Basic principles and procedures were adapted from previous research. WBV is followed by 20 minutes of DNS training, including specific movement exercises according to the DNS approach accompanied by breathing, coordination, mobility, and stability core exercises and routines suggested in previous studies. During the experiment, the MIX intervention group performed three training sessions weekly.

Control group (CONTROL) The control group did not exercise or use any training intervention or other habitual training during the past two months. During this period, the control group maintained their regular daily routines without any modifications. They refrained from engaging in any form of physical activity or participating in training programs that could influence their fitness levels.

Statistical analyses G*power 3.1 power analysis software (Heinrich-Heine-University, Düsseldorf, Germany) estimated the minimum total sample size (N=140) given the critical F(3, 136)=2.67, an effect size f=0.14 (partial η2=0.02), p=0.05, 1-β=0.80, groups=4, time points=2, and correlation among the measurements=0.50. The authors presented data as means and 95% confidence intervals [95% CIs]. The Kolmogorov-Smirnov, Leven's, Box's, and Mauchly's tests confirmed the assumptions of normality, homogeneity of variances and covariances, and sphericity, respectively. General linear models (twelve separate 2x4 mixed-design analyses of covariances for each PS measure) estimated whether mean changes [95% CIs] in PS measure from initial to final testing depended on whether participants received the DNS, VIBRO, and MIX exercise program or did not (CONTROL) after controlling for mean-centered BMI. Following the time-by-group interaction effects, which revealed whether estimated changes over time depended on the participants' group (i.e., differed at least between one group-comparison pair), we computed simple effects tests to estimate mean changes over time (mean difference from initial to final testing) within the groups. The follow-up investigation proceeded with contrast analysis, which assessed the degree to which estimated mean changes of PS measures differed between the group-comparison pairs. The authors calculated the effect size for time-by-group interaction effects and simple effects using partial eta squared (partial η2: 0.01 small; 0.06 medium; 0.14 large) and Hedge's g average (Hedge'sav: <|0.20| trivial; |0.20| small; |0.50| medium; |0.80| large), respectively. The Bonferroni test corrected p-values and 95% CI; the alpha level was p≤0.05. We used SPSS version 23.0 (SPSS Inc., Chicago, IL, USA) and GraphPad Prism version 8.0 (GraphPad Software, San Diego, California, USA) to analyse and plot the data, respectively.

Being tested
Dynamic neuromuscular stabilisation group, Whole body vibration group, Dynamic neuromuscular stabilisation with whole body vibration group
Keywords
postural control, exercise, vibration training, balance, neuromuscular adaptation
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic neuromuscular stabilisation groupOther

    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.

  • Whole body vibration groupOther

    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.

  • Dynamic neuromuscular stabilisation with whole body vibration groupOther

    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.

Study groups in NCT06294002
Study groupRoleWhat they receive
Dynamic neuromuscular stabilization group (DNS)ExperimentalDNS - Dynamic neuromuscular stabilization intervention
Receives: Other: Dynamic neuromuscular stabilisation group
Whole body vibration group (VIBRO)ExperimentalVIBRO - Whole body vibration intervention
Receives: Other: Whole body vibration group
Dynamic neuromuscular stabilisation with whole body vibration group (MIX)ExperimentalMIX group - neuromuscular and whole body vibration intervention
Receives: Other: Dynamic neuromuscular stabilisation with whole body vibration group
Control group (CONTROL)No interventionControl group - no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. 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.

    Measured: 2 months

  4. 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.

    Measured: 2 months

  5. 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..

    Measured: 2 months

  6. 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.

    Measured: 2 months

  7. 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.

    Measured: 2 months

  8. 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.

    Measured: 2 months

Secondary outcomes (6)
  1. Sex

    The sex of the participants is recorded at the start of the study.

    Measured: 2 months

  2. Date of birth

    The participant's date of birth is collected in order to calculate his age in years.

    Measured: 2 months

  3. Weight

    The weight of the participants is analyzed in kilograms.

    Measured: 2 months

  4. Height

    The height of the subject is determined in meters.

    Measured: 2 months

  5. Body Mass Index (BMI)

    The participant's BMI is calculated from his height and weight.

    Measured: 2 months

  6. Adherence

    Adherence to the program is calculated from the record of the percentage of attendance at the intervention sessions.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start15 Feb 2022
  3. Primary completion20 Feb 2022
  4. Study completion25 Jun 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06294002
Sponsor's protocol ID
46-06-04/2020-1
Acronym
STABLEFIT
Status last verified
Mar 2024
First submitted
20 Feb 2024
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35496239

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic neuromuscular stabilisation group, Whole body vibration group and Dynamic neuromuscular stabilisation with whole body vibration group in people with Postural Stability, run by University of Novi Sad at 1 site in Serbia.

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 2 inclusion and 3 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 6 Mar 2024. 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 Serbia. 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?

Double-leg static postural stability sway area (time frame: 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06294002, which also lists 1 linked publication.

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 6 Mar 2024.

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