Injury PreventionNCT02654275
Effect of Proprioceptive Intervention Training on Power Capacity, Proprioceptive Ability and Technique of Young Swimmers
A study testing Proprioceptive Intervention in people with Injury Prevention, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Many children and adolescents who engage in swimming complain of shoulder pain during or after exercise. This pain may worsen and may lead to a decline in performance as well avoidance of swimming and lastly avoidance of any physical activity whatsoever. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Injury Prevention
- What is being tested?
- Proprioceptive Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Feb 2017
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy
- Swim 3 times per week
Who cannot join
- Have not had orthopedic surgery
- No history of disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wingate College
Netanya
Nili Steinberg, PhD, 972-9-8639245, knopp@wincol.ac.il
Nili Steinberg, PhD
About this study
Many children and adolescents who engage in swimming complain of shoulder pain during or after exercise. This pain may worsen and may lead to a decline in performance as well avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of this study is to determine whether proprioceptive intervention training will effect the power capacity, proprioceptive ability and technique of young swimmers.
- Conditions
- Injury Prevention
- Being tested
- Proprioceptive Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Intervention | Active comparator | Strength training on a non-stable surface Receives: Other: Proprioceptive Intervention |
| No Proprioceptive Intervention | No intervention | Conventional strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proprioceptive ability
Biodex Device which measures joint proprioceptive ability, will measure the change before and after training
Measured: 8 weeks
Secondary outcomes (1)
Change in muscle strength
Biodex Device will measure the change in muscle isokinetic strength before and after training
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury PreventionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Wingate College
- Responsible party
- Sponsor
- Investigators
- Eias Kassem, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654275
- Sponsor's protocol ID
- 17-15-HYMC
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioceptive Intervention Training on Power Capacity, Proprioceptive Ability and Technique of Young Swimmers
- ClinicalTrials.gov ID
- NCT02654275
- Acronym / sponsor ID
- 17-15-HYMC
- Conditions
- Injury Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Wingate College
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- 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.
Many children and adolescents who engage in swimming complain of shoulder pain during or after exercise. This pain may worsen and may lead to a decline in performance as well avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of this study is to determine whether proprioceptive intervention training will effect the power capacity, proprioceptive ability and technique of young swimmers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Intervention | Active comparator | Other: Proprioceptive InterventionStrength training on a non-stable surface |
| No Proprioceptive Intervention | No intervention | –Conventional strength training |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy
- Swim 3 times per week
Key exclusion criteria (2 listed)
- Have not had orthopedic surgery
- No history of disease
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 |
|---|---|---|
| Proprioceptive Intervention | Other | Proprioceptive Intervention |
Primary outcome
Change in proprioceptive ability
Time frame: 8 weeks
Biodex Device which measures joint proprioceptive ability, will measure the change before and after training
1 secondary outcome
Change in muscle strength
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Eias Kassem, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Intervention in people with Injury Prevention, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nili Steinberg, PhD (972-9-8639245, knopp@wincol.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proprioceptive ability (time frame: 8 weeks). 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 13 Jan 2016.