Adult Female Handball PlayerNCT04432441
Effects of Neuromuscular Electrostimulation on Scapular Stability
A study testing Therapeutic physical exercise program for scapulo-humeral stabilitation and Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation in people with Adult Female Handball Player, run by University of Extremadura at 1 site in Spain.
Trial summary
Injuries and shoulder pain are common problems in handball, more often among female athletes. The impact on performance and participation shows the need to work on the risk factors to minimize the damage. It has been found an association between scapular dysfunction and pain in the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adult Female Handball Player
- What is being tested?
- Therapeutic physical exercise program for scapulo-humeral stabilitation and Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 11 Jun 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To have more than 18 YO
- To be female
- To do at least 5 hour of sport training per week in last two years
- To be part of federated club that allows them in their weekly practice to participate in recreational matches or small local championship during weekends.
- To have scapular diskinesis by McClure scale
Who cannot join
- To have an actual injury
- To have an history of injury in last 12 months
- To take drugs that can affect to control motor.
- To be part or participate in a control motor program or specific prevention program
- To have a recent surgery in last year in upper or back.
- A score below 45 points on the Personal Psychological Apprehension Scale.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neuromuscular Electrical Stimulation (NMES) Plus Therapeutic Exercise Combination on Scapular Stability in Female Professional Handball Players With Scapular Dyskinesia
Injuries and shoulder pain are common problems in handball, more often among female athletes. The impact on performance and participation shows the need to work on the risk factors to minimize the damage. It has been found an association between scapular dysfunction and pain in the shoulder. Currently there are many exercise programs, but few with electrotherapy implemented. The aim of the study is to assess the effect of a therapeutic physical exercise program for scapulo-humeral stabilitation with and without electrotherapy on scapular stability, glenohumeral internal rotation and external rotation strength.
- Conditions
- Adult Female Handball Player
- Being tested
- Therapeutic physical exercise program for scapulo-humeral stabilitation, Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation
- Keywords
- "Electric Stimulation Therapy", "Resistance training", "Overhead sports", "Risk factors", "Scapular anomalies"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic physical exercise program for scapulo-humeral stabilitationOther
This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation during a month
Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulationOther
This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation added electrostimulation during a month
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic physical exercise program for scapulo-humeral stabilitation | Active comparator | Therapeutic physical exercise program for scapulo-humeral stabilitation Receives: Other: Therapeutic physical exercise program for scapulo-humeral stabilitation |
| Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation | Active comparator | Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation Receives: Other: Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapular Static Positioning Assessment: Upper distance
cm
Measured: Changes from baseline after a month
Scapular Static Positioning Assessment: Lower distance
cm
Measured: Changes from baseline after a month
Secondary outcomes (2)
RI Range of movement
Degrees
Measured: Changes from baseline after a month
External rotation strenght
kg
Measured: Changes from baseline after a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Feb 2021
- Primary completion16 Feb 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Female Handball PlayerStudies 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
- Model description
- Two groups. Experimental group realizes a therapeutic physical exercise program for scapulo-humeral stabilitation, and the other group (control group) the same program with electrostimulation. The programme consisted of a two-part sequence of isometric prone push-up, being it an optimal position for periscapular stability exercises.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Luis Espejo Antúnez, Antoni Morral
- Responsible party
- Principal investigator, Javier Gutiérrez Coronado, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432441
- Sponsor's protocol ID
- 19741974
- Status last verified
- Nov 2021
- First submitted
- 8 Jun 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation (NMES) Plus Therapeutic Exercise Combination on Scapular Stability in Female Professional Handball Players With Scapular Dyskinesia
- ClinicalTrials.gov ID
- NCT04432441
- Acronym / sponsor ID
- 19741974
- Conditions
- Adult Female Handball Player
- Keywords
- "Electric Stimulation Therapy", "Resistance training", "Overhead sports", "Risk factors", "Scapular anomalies"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Collaborators
- Luis Espejo Antúnez, Antoni Morral
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 16 Jun 2020 (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.
Injuries and shoulder pain are common problems in handball, more often among female athletes. The impact on performance and participation shows the need to work on the risk factors to minimize the damage. It has been found an association between scapular dysfunction and pain in the shoulder. Currently there are many exercise programs, but few with electrotherapy implemented. The aim of the study is to assess the effect of a therapeutic physical exercise program for scapulo-humeral stabilitation with and without electrotherapy on scapular stability, glenohumeral internal rotation and external rotation strength.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups. Experimental group realizes a therapeutic physical exercise program for scapulo-humeral stabilitation, and the other group (control group) the same program with electrostimulation. The programme consisted of a two-part sequence of isometric prone push-up, being it an optimal position for periscapular stability exercises.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic physical exercise program for scapulo-humeral stabilitation | Active comparator | Other: Therapeutic physical exercise program for scapulo-humeral stabilitationTherapeutic physical exercise program for scapulo-humeral stabilitation |
| Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation | Active comparator | Other: Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulationTherapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To have more than 18 YO
- To be female
- To do at least 5 hour of sport training per week in last two years
- To be part of federated club that allows them in their weekly practice to participate in recreational matches or small local championship during weekends.
- To have scapular diskinesis by McClure scale
Key exclusion criteria (6 listed)
- To have an actual injury
- To have an history of injury in last 12 months
- To take drugs that can affect to control motor.
- To be part or participate in a control motor program or specific prevention program
- To have a recent surgery in last year in upper or back.
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 |
|---|---|---|
| Therapeutic physical exercise program for scapulo-humeral stabilitationThis group realize a therapeutic physical exercise program for scapulo-humeral stabilitation during a month | Other | Therapeutic physical exercise program for scapulo-humeral stabilitation |
| Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulationThis group realize a therapeutic physical exercise program for scapulo-humeral stabilitation added electrostimulation during a month | Other | Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation |
Primary outcome
Scapular Static Positioning Assessment: Upper distance
Time frame: Changes from baseline after a month
cm
Scapular Static Positioning Assessment: Lower distance
Time frame: Changes from baseline after a month
cm
2 secondary outcomes
RI Range of movement
Time frame: Changes from baseline after a month
External rotation strenght
Time frame: Changes from baseline after a month
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 16 Nov 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic physical exercise program for scapulo-humeral stabilitation and Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation in people with Adult Female Handball Player, run by University of Extremadura at 1 site in Spain.
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 5 inclusion and 6 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 16 Nov 2021. 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 Spain. 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?
Scapular Static Positioning Assessment: Upper distance (time frame: Changes from baseline after a month). 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?
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 16 Nov 2021.