NCT03063814

Brief Summary

Therefore, the aim of the present study was to evaluate neuromuscular characteristics observed during a single bout of selected and validated injury preventive exercises instructed by an app (in accordance with 'Get set - Train smarter') versus gold standard instruction, supervision and feedback provided on-site by an expert. The present evaluation targets a population of female football and handball players without any previous exposure to injury prevention training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

February 17, 2017

Last Update Submit

February 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Normalized hamstring EMG

    Normalized to isometric MVC hamstring muscle EMG amplitude recorded during the exercise.

    5 minutes after instruction

Secondary Outcomes (2)

  • Normalized quadriceps EMG

    5 minutes after instruction

  • Joint angle

    5 minutes after instruction

Study Arms (2)

APP

EXPERIMENTAL

In the APP group, a video sequence of each exercise, supported by short written descriptions (in accordance to 'Get set - Train smarter', (9) on how to perform the exercise correctly, was shown to the participants on an iPad. The video-recorded exercises were performed by the same physiotherapist who supervised PHY participants. If required, the participants in the APP group were allowed to watch the video and description several times between trials of the same exercise. The participants approved their own trials when they believed that the exercises had been performed as described.

Behavioral: APP

PHY

ACTIVE COMPARATOR

In PHY, a physiotherapist demonstrated and explained the focus areas of each of the five exercises before the participant performed the exercises. If needed, verbal feedback was given between trials to correct the performance of the exercise. The physiotherapist approved trials that were performed with proper technique.

Behavioral: PHY

Interventions

APPBEHAVIORAL

See arm description

APP
PHYBEHAVIORAL

see arm description

PHY

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female handball or football player (≥ 18 years old) competing at sub-elite level (i.e., 2-3 weekly training sessions)

You may not qualify if:

  • previous traumatic knee injury, lower limb injury at the time of testing and/or previous engagement in injury prevention practices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hivdovre, 2650, Denmark

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Mette K Zebis, PhD

    Metropolitan University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 24, 2017

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations