Time-course of balance training-related changes on static and dynamic balance performance in healthy children
| ISRCTN | ISRCTN16518737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16518737 |
- Submission date
- 14/08/2023
- Registration date
- 24/08/2023
- Last edited
- 20/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In children, there is evidence of improvements in static and dynamic balance performance following balance training. However, the time course of balance training-related changes is unknown. In fact, the time course of changes in balance with training has so far only been studied in older adults. Yet, transferring these findings to children is not legitimate, as older adults are subject to age-related degradation processes in the sensory and motor systems. Therefore, the aim of the study was to investigate the time course of balance training-related changes (i.e., after 1, 3, and 6 weeks of BT) on measures of static and dynamic balance in healthy children.
Who can participate?
Healthy children aged between 6 and 12 years old
What does the study involve?
This study investigates the effects of balance training on measures of static and dynamic balance in participants in an intervention group who will undertake 2 x 25 minutes of balance exercises per week compared with those in the control group who will undertake 2 x 25 minutes of track and field exercises and soccer practice per week. Participants will undergo tests for their static (i.e., stance time in the One-Legged Stance test) and dynamic (i.e., step number in the 3-m Beam Walking Backward test) balance performance at 1, 3 and 6 weeks.
What are the possible benefits and risks of participating?
The benefits are improvements in static and dynamic balance performance and there is a risk of muscular fatigue after training.
Where is the study run from?
The study was performed in public schools and is run by the University of Duisburg-Essen (Germany)
When is the study starting and how long is it expected to run for?
April 2023 to June 2023
Who is funding the study?
Division of Training and Movement Sciences/Biomechanics of Sport at the University of Duisburg-Essen (Germany)
Who is the main contact?
Thomas Muehlbauer, thomas.muehlbauer@uni-due.de
Contact information
Principal Investigator
University of Duisburg-Essen
Gladbecker Str. 182
Essen
45141
Germany
 ORCID ID |
0000-0001-7774-8664 |
|---|---|
| Phone | +492018137333 |
| thomas.muehlbauer@uni-due.de |
Study information
| Study design | Cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Time-course of balance training-related changes |
| Study acronym | TCBT |
| Study objectives | We hypothesised that BT would result in balance improvements, which take place in as little as two sessions per week (i.e., after 1 week of BT). |
| Ethics approval(s) |
Approved 10/07/2017, Human Ethics Committee at the University of Duisburg-Essen, Faculty of Educational Sciences (University of Duisburg-Essen, University Street 2 Room: S06 S03 A31, Essen, 45141, Germany; +49 (0) 201 / 183 7237; ethik-psychologie@uni-due.de), ref: TM_10.07.2017 |
| Health condition(s) or problem(s) studied | Promotion of balance performance |
| Intervention | The study employed cluster randomization based on school class. The study consisted of balance training given in an intervention group: balance training 2 x 25 minutes of balance exercises per week, 6 weeks in total; and an active control group: 2 x 25 minutes of track and field exercises and soccer practice per week, 6 weeks in total; participants are randomly assigned to the intervention group or control group; both treatments were supervised by two graduated students (i.e., sports scientists); group-based treatments provided in the school-gym. |
| Intervention type | Behavioural |
| Primary outcome measure | Static and dynamic balance performance was measured using stance time in the One-Legged Stance test and by counting step number in the 3-m Beam Walking Backward test before and after 1, 3, and 6 weeks of treatments |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/03/2017 |
| Completion date | 13/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 42 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Voluntary participation 2. Aged between 6 and 12 years old |
| Key exclusion criteria | Neurological or musculoskeletal impairment |
| Date of first enrolment | 11/04/2023 |
| Date of final enrolment | 17/04/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Oberhausen
46145
Germany
Sponsor information
University/education
Universitätstrasse 2
Essen
45141
Germany
| Phone | +492011837224 |
|---|---|
| uta.schmitz@uni-due.de | |
"ROR" |
https://ror.org/04mz5ra38 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Duisburg-Essen, UDE
- Location
- Germany
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during the current study will be available upon request from Thomas Muehlbauer, thomas.muehlbauer@uni-due.de. *.csv data will be shared upon request; the time limit for availability is 5 years; written informed consent and subject’s assent were obtained from all participants before the start of the study. In addition, parents’ approval was obtained for minors; data were anonymized; there are no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/03/2024 | 20/03/2024 | Yes | No |
Editorial Notes
20/03/2024: Publication reference added.
04/09/2023: The intention to publish date was changed from 30/09/2023 to 31/12/2023.
15/08/2023: Trial's existence confirmed by the Ethics Committee of The Faculty for Educational Sciences, Institute of Psychology, University of Duisburg-Essen (Germany).
