Proprioceptive DisordersNCT04289584
Exercises With Elastic Bands and Stability in Proprioception and Strength in Female Athletes of Taekwondo
A study testing Strength and proprioception exercises in people with Proprioceptive Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Strength and proprioception exercises are used to improve the strength and unipodal balance of lower limbs in Taekwondo players. The moments of unipodal support in Taekwondo require a great demand that is necessary to adapt the athlete through the development of strength and proprioception. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Strength and proprioception exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 10 Jun 2020
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female Taekwondo players
- Age range of 18 to 30 years
- More than 2 years of sports practice of taekwondo, federated
- Currently participate in regional or national competitions.
Who cannot join
- Participants who have some type of musculoskeletal lesion in the lower limbs
- That are belts below the color green
- Have not competed in the last year in any regional or national competition.
- Have not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Intervention Through Exercises With Elastic Bands and Stability Exercises in the Improvement of Proprioception and Strength During Unipodal Support in Women Athletes of Taekwondo. A Randomized Clinical Study.
Strength and proprioception exercises are used to improve the strength and unipodal balance of lower limbs in Taekwondo players. The moments of unipodal support in Taekwondo require a great demand that is necessary to adapt the athlete through the development of strength and proprioception.
The main objective of the study is to assess the effectiveness of strength work with elastic bands and balance exercises in increasing strength and unipodal proprioception in taekwondists aged 18 to 30 years.
Read more
Randomized, single blind clinical study 30 taekwondists will be randomized to the two study groups: experimental (strength training and proprioception) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions each session will be approximately 15 minutes each. The study variables will be: unipodal muscle strength (jump test), and lower limb balance (Y-Balance test). The sample distribution will be calculated using a Kolmogorov-Smmirnof analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
After the training period it is intended to obtain improvement in the strength of the lower limbs, as well as an increase in balance during unipodal support during the execution of a movement.
- Conditions
- Proprioceptive Disorders
- Being tested
- Strength and proprioception exercises
- Keywords
- Taekwondo, Strength, Balance, Theraband, Proprioception
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and proprioception exercisesOther
Strength and proprioception exercises will be performed with the athlete in different positions depending on the exercise. There will be 3 series with 30 repetitions and 10-second breaks between sets. Each exercise session will be held for 15 minutes. Theraband® exercises are: unipodal balancing on hard surface with open and closed eyes, unipodal balancing on soft surface, squats, lateral walk, isometric contractions with garter and dynamic leg opening, tiptoe, and eccentric hamstring curl with garter.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each session will last 15 minutes, taking place for 2 days a week, over a period of 4 weeks. The intervention will take place at the beginning of the training session. Prior to training, strength and proprioception exercises will be performed. Receives: Other: Strength and proprioception exercises |
| Control group | No intervention | The players included in the control group will follow their usual routine prior to their Taekwondo training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline strength after treatment and at month
It will be done using the Hop test, measuring the single jump for distance The test will be done twice and the result will be the average of the two values to calculate the symmetry of the limbs. Before carrying out the test it is necessary to create a horizontal line as a starting point and six meters to there a horizontal line as an end point. A vertical 15 cm line will be placed as a reference point for the cross jump from the starting line to the finishing line. The simple jump of distance consists in realizing a jump starting from a monopodal support and falling of the jump with the same leg that realizes the impulse. The unit of measure is the centimeter, based on the distance traveled.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (1)
Change from baseline stability after treatment and at month
It will be done by applying the Y-Balance test. With this test, the unipodal stability of each lower limb will be measured. To perform the test you must create a "Y" figure on the floor. The athlete will place one foot barefoot at the central point of the "Y", while the other foot should be carried along the lines in the 3 directions: anterior, posterolateral and posteromedial. The players will be asked to stretch their foot as much as possible without losing their balance, then returning to the starting point. Three repetitions will be performed and the result will be the average of these measures. There will be a 15 second break between each unilateral take and 30 seconds between each foot.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start2 Mar 2020
- Primary completion30 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289584
- Sponsor's protocol ID
- TKD
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention Through Exercises With Elastic Bands and Stability Exercises in the Improvement of Proprioception and Strength During Unipodal Support in Women Athletes of Taekwondo. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04289584
- Acronym / sponsor ID
- TKD
- Conditions
- Proprioceptive Disorders
- Keywords
- Taekwondo, Strength, Balance, Theraband, Proprioception
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strength and proprioception exercises are used to improve the strength and unipodal balance of lower limbs in Taekwondo players. The moments of unipodal support in Taekwondo require a great demand that is necessary to adapt the athlete through the development of strength and proprioception.
The main objective of the study is to assess the effectiveness of strength work with elastic bands and balance exercises in increasing strength and unipodal proprioception in taekwondists aged 18 to 30 years.
Randomized, single blind clinical study 30 taekwondists will be randomized to the two study groups: experimental (strength training and proprioception) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions each session will be approximately 15 minutes each. The study variables will be: unipodal muscle strength (jump test), and lower limb balance (Y-Balance test). The sample distribution will be calculated using a Kolmogorov-Smmirnof analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
After the training period it is intended to obtain improvement in the strength of the lower limbs, as well as an increase in balance during unipodal support during the execution of a movement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Strength and proprioception exercisesEach session will last 15 minutes, taking place for 2 days a week, over a period of 4 weeks. The intervention will take place at the beginning of the training session. Prior to training, strength and proprioception exercises will be performed. |
| Control group | No intervention | –The players included in the control group will follow their usual routine prior to their Taekwondo training. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female Taekwondo players
- Age range of 18 to 30 years
- More than 2 years of sports practice of taekwondo, federated
- Currently participate in regional or national competitions.
Key exclusion criteria (4 listed)
- Participants who have some type of musculoskeletal lesion in the lower limbs
- That are belts below the color green
- Have not competed in the last year in any regional or national competition.
- Have not signed the informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength and proprioception exercisesStrength and proprioception exercises will be performed with the athlete in different positions depending on the exercise. There will be 3 series with 30 repetitions and 10-second breaks between sets. Each exercise session will be held for 15 minutes. Theraband® exercises are: unipodal balancing on hard surface with open and closed eyes, unipodal balancing on soft surface, squats, lateral walk, isometric contractions with garter and dynamic leg opening, tiptoe, and eccentric hamstring curl with garter. | Other | Experimental group |
Primary outcome
Change from baseline strength after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
It will be done using the Hop test, measuring the single jump for distance The test will be done twice and the result will be the average of the two values to calculate the symmetry of the limbs. Before carrying out the test it is necessary to create a horizontal line as a starting point and six meters to there a horizontal line as an end point. A vertical 15 cm line will be placed as a reference point for the cross jump from the starting line to the finishing line. The simple jump of distance consists in realizing a jump starting from a monopodal support and falling of the jump with the same leg that realizes the impulse. The unit of measure is the centimeter, based on the distance traveled.
1 secondary outcome
Change from baseline stability after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and proprioception exercises in people with Proprioceptive Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Sep 2021. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline strength after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.