Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589050
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Improving Foot Strength in Vocational Ballet Dancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Two Foot Strengthening Interventions on Toe Flexor Strength and Jumping Performance in Vocational Ballet Dancers A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Professional dancers subject their feet to high forces through frequent jumping repeated heel rises insufficient shoe cushioning and a high degree of foot mobility To prevent injuries and improve jumping performance dancers are recommended to strengthen the muscles of the lower extremities
The foot muscles especially the toe flexors play an important role as shock absorbers and motors for the foot by absorbing and generating mechanical energy which is essential for human locomotion Furthermore they serve as a link between the powerful leg extensor muscles and the ground transmitting the energy generated by the larger muscle groups This makes them essential components of overall athletic performance However the impact of foot muscle strength on dancers jumping performance remains uncertain Therefore the aim of this study is to investigate the effectiveness of two training programs designed to strengthen the toe flexor muscles in dancers For this project a 65-week intervention with ballet students from a vocational ballet school is planned Before and after the intervention all study participants will perform tests to assess foot muscle strength and jumping performance
The foot muscles especially the toe flexors play an important role as shock absorbers and motors for the foot by absorbing and generating mechanical energy which is essential for human locomotion Furthermore they serve as a link between the powerful leg extensor muscles and the ground transmitting the energy generated by the larger muscle groups This makes them essential components of overall athletic performance However the impact of foot muscle strength on dancers jumping performance remains uncertain Therefore the aim of this study is to investigate the effectiveness of two training programs designed to strengthen the toe flexor muscles in dancers For this project a 65-week intervention with ballet students from a vocational ballet school is planned Before and after the intervention all study participants will perform tests to assess foot muscle strength and jumping performance
Detailed Description:
This study aims to develop two different toe flexor TF exercise programs for vocational dancers to enhance TF strength and jumping performance It is hypothesized that i both training programs increase TF strength and jumping performance ii horizontal jumps are more affected than vertical jumps and iii the TF exercise program with the TF strengthening device has a greater impact on TF strength
Participants
Participants will be recruited from a vocational ballet school via an email detailing the study outline They and their legal guardians for participants under 18 years old will be informed of the potential risks and benefits of the study They will provide written informed consent prior to the measurements Participants will then be assigned to either a control group a toe flexor device experimental group or a heel rise experimental group The schedule includes three and a half weeks of training a 12-day break due to the school schedule followed by another three weeks of training This will result in a total of 26 training sessions An experienced trainer will supervise all training sessions The control group will continue with the ballet schools normal training schedule
Data collection and management
An intervention protocol will be kept to collect information on compliance and progression of the training such as the number of repetitions and the resistance applied Data analysis will be performed according to the intention-to-treat ITT principle in which participants are analyzed according to their original treatment group assignment An additional researcher will manage reporting for adverse effects such as delayed onset muscle soreness and adverse events All data collected in this study will be anonymized personal identifiers removed and data coded to protect the identities of the participants
Sample size
Due to the studys novel character no sample size calculations have been conducted To the researchers best knowledge no comparable protocols to improve TF strength have been investigated so a sample size calculation was not warranted The study is therefore exploratory
Statistical analysis
Variables will be presented as the mean standard deviation The Shapiro-Wilk test will be performed to assess the normality of the measured variables Repeated-measures Analysis of Variance ANOVA with Bonferroni correction will be used to analyze variables across different times and groups Non-normally distributed variables will be analyzed using Friedman ANOVA and Kruskal-Wallis ANOVA with multiple comparisons of mean ranks for individual comparisons Statistical analyses will be performed using IBM SPSS Statistics for Windows Version 290 and the statistical significance level will be set to 05 If the primary andor secondary outcomes yield null findings equivalence testing will be conducted to determine whether the intervention is equivalent to the usual training control group The two one-sided tests TOST procedure will be applied using either standardized differences eg Cohens d or raw differences
Participants
Participants will be recruited from a vocational ballet school via an email detailing the study outline They and their legal guardians for participants under 18 years old will be informed of the potential risks and benefits of the study They will provide written informed consent prior to the measurements Participants will then be assigned to either a control group a toe flexor device experimental group or a heel rise experimental group The schedule includes three and a half weeks of training a 12-day break due to the school schedule followed by another three weeks of training This will result in a total of 26 training sessions An experienced trainer will supervise all training sessions The control group will continue with the ballet schools normal training schedule
Data collection and management
An intervention protocol will be kept to collect information on compliance and progression of the training such as the number of repetitions and the resistance applied Data analysis will be performed according to the intention-to-treat ITT principle in which participants are analyzed according to their original treatment group assignment An additional researcher will manage reporting for adverse effects such as delayed onset muscle soreness and adverse events All data collected in this study will be anonymized personal identifiers removed and data coded to protect the identities of the participants
Sample size
Due to the studys novel character no sample size calculations have been conducted To the researchers best knowledge no comparable protocols to improve TF strength have been investigated so a sample size calculation was not warranted The study is therefore exploratory
Statistical analysis
Variables will be presented as the mean standard deviation The Shapiro-Wilk test will be performed to assess the normality of the measured variables Repeated-measures Analysis of Variance ANOVA with Bonferroni correction will be used to analyze variables across different times and groups Non-normally distributed variables will be analyzed using Friedman ANOVA and Kruskal-Wallis ANOVA with multiple comparisons of mean ranks for individual comparisons Statistical analyses will be performed using IBM SPSS Statistics for Windows Version 290 and the statistical significance level will be set to 05 If the primary andor secondary outcomes yield null findings equivalence testing will be conducted to determine whether the intervention is equivalent to the usual training control group The two one-sided tests TOST procedure will be applied using either standardized differences eg Cohens d or raw differences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None