NCT02925377

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 4, 2016

Last Update Submit

October 4, 2016

Conditions

Postural Balance

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline: Static postural control

    Postural sway (center of pressure sway velocity) during unipedal quiet standing, eyes opened (20 seconds)

    3, 6, 9, and 11 weeks

  • Change from Baseline: Dynamic postural control

    Star Excursion Balance Test (SEBT)

    3, 6, 9, and 11 weeks

Study Arms (2)

Neuromuscular

EXPERIMENTAL

Neuromuscular warm-up

Behavioral: Neuromuscular warm-up

Control

ACTIVE COMPARATOR

Standard warm-up

Behavioral: Standard warm-up

Interventions

Neuromuscular warm-upBEHAVIORAL

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.

Neuromuscular
Standard warm-upBEHAVIORAL

Athletes in the control group followed their regular 15 minutes warm-up routine provided by the team coaches.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gender: Female
  • Handball players
  • Actively participated in competitions
  • Uninjured at study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sport Science and Sport; FAU Erlangen-Nürnberg

Erlangen, Bavaria, 91058, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27757240DERIVED

Study Officials

  • Astrid Zech, Prof. Dr.

    Institute of Sports Science, Friedrich-Schiller-Universität Jena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

DE(1)