Postural BalanceNCT02925377
Neuromuscular Warm-up Intervention to Improve Postural Control in Female Handball Players
A study testing Neuromuscular warm-up and Standard warm-up in people with Postural Balance, run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial summary
Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Neuromuscular warm-up and Standard warm-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to May 2011
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: Female
- Handball players
- Actively participated in competitions
- Uninjured at study enrollment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Sport Science and Sport; FAU Erlangen-Nürnberg
Erlangen, Bavaria, 91058
About this study
Official title: Efficacy of a Specific Warm-up Program to Improve Static and Dynamic Postural Control in Adult Female Handball Players
Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control.
- Conditions
- Postural Balance
- Being tested
- Neuromuscular warm-up, Standard warm-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular warm-upBehavioural
The intervention group replaced their regular warm-up routine with seven neuromuscular warm-up exercises performed for 15 minutes prior to each practice session (3x/week) over a period of eleven weeks.
Standard warm-upBehavioural
Athletes in the control group followed their regular 15 minutes warm-up routine provided by the team coaches.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular | Experimental | Neuromuscular warm-up Receives: Behavioral: Neuromuscular warm-up |
| Control | Active comparator | Standard warm-up Receives: Behavioral: Standard warm-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline: Static postural control
Postural sway (center of pressure sway velocity) during unipedal quiet standing, eyes opened (20 seconds)
Measured: 3, 6, 9, and 11 weeks
Change from Baseline: Dynamic postural control
Star Excursion Balance Test (SEBT)
Measured: 3, 6, 9, and 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Astrid Zech, Prof. Dr., Principal investigator, Institute of Sports Science, Friedrich-Schiller-Universität Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925377
- Sponsor's protocol ID
- 115_15Bc
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Steib S, Zahn P, Zu Eulenburg C, Pfeifer K, Zech A. Time-dependent postural control adaptations following a neuromuscular warm-up in female handball players: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Oct 13;8:33. doi: 10.1186/s13102-016-0058-5. eCollection 2016.
PubMed 27757240
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Specific Warm-up Program to Improve Static and Dynamic Postural Control in Adult Female Handball Players
- ClinicalTrials.gov ID
- NCT02925377
- Acronym / sponsor ID
- 115_15Bc
- Conditions
- Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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.
Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular | Experimental | Behavioral: Neuromuscular warm-upNeuromuscular warm-up |
| Control | Active comparator | Behavioral: Standard warm-upStandard warm-up |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gender: Female
- Handball players
- Actively participated in competitions
- Uninjured at study enrollment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Neuromuscular warm-upThe intervention group replaced their regular warm-up routine with seven neuromuscular warm-up exercises performed for 15 minutes prior to each practice session (3x/week) over a period of eleven weeks. | Behavioural | Neuromuscular |
| Standard warm-upAthletes in the control group followed their regular 15 minutes warm-up routine provided by the team coaches. | Behavioural | Control |
Primary outcome
Change from Baseline: Static postural control
Time frame: 3, 6, 9, and 11 weeks
Postural sway (center of pressure sway velocity) during unipedal quiet standing, eyes opened (20 seconds)
Change from Baseline: Dynamic postural control
Time frame: 3, 6, 9, and 11 weeks
Star Excursion Balance Test (SEBT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 27757240Steib S, Zahn P, Zu Eulenburg C, Pfeifer K, Zech A. Time-dependent postural control adaptations following a neuromuscular warm-up in female handball players: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Oct 13;8:33. doi: 10.1186/s13102-016-0058-5. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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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.
Astrid Zech, Prof. Dr. principal investigator
Institute of Sports Science, Friedrich-Schiller-Universität Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular warm-up and Standard warm-up in people with Postural Balance, run by University of Erlangen-Nürnberg at 1 site in Germany.
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 1 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 5 Oct 2016. 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 Germany. 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?
Change from Baseline: Static postural control (time frame: 3, 6, 9, and 11 weeks). The study lists 2 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 NCT02925377, 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 5 Oct 2016.