- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03063814
Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises (ACL01)
February 21, 2017 updated by: National Research Centre for the Working Environment, Denmark
Immediate Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises: Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hivdovre, Denmark, 2650
- Hvidovre Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female handball or football player (≥ 18 years old) competing at sub-elite level (i.e., 2-3 weekly training sessions)
Exclusion Criteria:
- previous traumatic knee injury, lower limb injury at the time of testing and/or previous engagement in injury prevention practices.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: APP
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.
|
See arm description
|
|
ACTIVE_COMPARATOR: PHY
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.
|
see arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Normalized hamstring EMG
Time Frame: 5 minutes after instruction
|
Normalized to isometric MVC hamstring muscle EMG amplitude recorded during the exercise.
|
5 minutes after instruction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Normalized quadriceps EMG
Time Frame: 5 minutes after instruction
|
Normalized EMG amplitude of the quadriceps muscle recorded during the exercise.
|
5 minutes after instruction
|
|
Joint angle
Time Frame: 5 minutes after instruction
|
Joint angle during the exercise
|
5 minutes after instruction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mette K Zebis, PhD, Metropolitan University College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2015
Primary Completion (ACTUAL)
January 1, 2016
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
February 17, 2017
First Submitted That Met QC Criteria
February 21, 2017
First Posted (ACTUAL)
February 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACL01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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