Musculoskeletal InjuryACL01NCT03063814
Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises
A study testing APP and PHY in people with Musculoskeletal Injury and Injury, Knee, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury, Injury, Knee
- What is being tested?
- APP and PHY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2015to 1 Jan 2016
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female handball or football player (≥ 18 years old) competing at sub-elite level (i.e., 2-3 weekly training sessions)
Who cannot join
- previous traumatic knee injury, lower limb injury at the time of testing and/or previous engagement in injury prevention practices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Musculoskeletal Injury, Injury, Knee
- Being tested
- APP, PHY
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPBehavioural
See arm description
PHYBehavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized hamstring EMG
Normalized to isometric MVC hamstring muscle EMG amplitude recorded during the exercise.
Measured: 5 minutes after instruction
Secondary outcomes (2)
Normalized quadriceps EMG
Normalized EMG amplitude of the quadriceps muscle recorded during the exercise.
Measured: 5 minutes after instruction
Joint angle
Joint angle during the exercise
Measured: 5 minutes after instruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Sep 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- Metropolitan University College
- Responsible party
- Sponsor
- Investigators
- Mette K Zebis, PhD, Principal investigator, Metropolitan University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063814
- Sponsor's protocol ID
- ACL01
- Acronym
- ACL01
- Status last verified
- Feb 2017
- First submitted
- 17 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03063814
- Acronym / sponsor ID
- ACL01 / ACL01
- Conditions
- Musculoskeletal Injury, Injury, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- Metropolitan University College
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 24 Feb 2017 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APP | Experimental | Behavioral: APPIn 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. |
| PHY | Active comparator | Behavioral: PHYIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female handball or football player (≥ 18 years old) competing at sub-elite level (i.e., 2-3 weekly training sessions)
Key exclusion criteria (1 listed)
- previous traumatic knee injury, lower limb injury at the time of testing and/or previous engagement in injury prevention practices.
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 |
|---|---|---|
| APPSee arm description | Behavioural | APP |
| PHYsee arm description | Behavioural | PHY |
Primary outcome
Normalized hamstring EMG
Time frame: 5 minutes after instruction
Normalized to isometric MVC hamstring muscle EMG amplitude recorded during the exercise.
2 secondary outcomes
Normalized quadriceps EMG
Time frame: 5 minutes after instruction
Joint angle
Time frame: 5 minutes after instruction
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 24 Feb 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Musculoskeletal Injury
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
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.
Mette K Zebis, PhD principal investigator
Metropolitan University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP and PHY in people with Musculoskeletal Injury and Injury, Knee, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
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 1 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 24 Feb 2017. 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 Denmark. 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?
Normalized hamstring EMG (time frame: 5 minutes after instruction). 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 24 Feb 2017.