Proprioceptive DisordersNCT03312062
Influence of Foam Rolling on Elbow Proprioception, Strength, and Functional Motor Performance
A study testing Foam Rolling Exercise in people with Proprioceptive Disorders, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the long-term effects of foam rolling on elbow proprioception, strength and functional motor performance with healthy participants . Study group will receive foam rolling exercise. Control group will receive no foam rolling exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Foam Rolling Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2017to 25 Dec 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and above healthy participants
- No pain in elbow area within 6 months and at the time of measurement
- To be able to complete all evaluations and applications to be carried out
Who cannot join
- Having previous foam rolling and self-myofascial relaxation applications on the target area
- Having acne and similar skin problems, open wounds
- Having upper extremity injury, history of fracture or surgery
- Having any systemic musculoskeletal disease
- Having diagnosis of diabetic mellitus or peripheral neuropathy
- Having osteoporosis diagnosis
Show all 9Show fewer
- Having any cardiovascular disease
- Having vertigo
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the long-term effects of foam rolling on elbow proprioception, strength and functional motor performance with healthy participants . Study group will receive foam rolling exercise. Control group will receive no foam rolling exercise. Control group will be given a brochure including information about proprioception and foam rolling.
Read the detailed description
There is no information in literature about the effects of foam rolling on elbow proprioception, strength and functional motor performance. The purpose of this study is to investigate long-term effects of foam rolling with healthy participants. Study group will receive foam rolling exercise actively by themselves on elbow.
Foam rolling exercise will be applied 10 times each for 1 minute. These exercises will be performed as 2 sets. After each set will be a resting period for 30 seconds.A total of 12 sessions of exercise will be performed three times a week. Second evaluation will be performed after 4 weeks. Then the follow up evaluation (third evaluation) will be performed 4 weeks later. Control group will receive no foam rolling exercise. They will be handed a brochure about the proprioception and its role in injury prevention and foam rolling. Control group will be evaluated for the first time. Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks.
- Conditions
- Proprioceptive Disorders
- Being tested
- Foam Rolling Exercise
- Keywords
- elbow, foam rolling, proprioception, motor performance, strength
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam Rolling ExerciseOther
Foam rolling exercise will be performed actively. Participants will use a foam roller for exercise. They will position the foam roller on the chair. Afterwards, they will use their body weights to rub the elbow area (biceps brachii muscle) with this foam. There will be 2 sets and each set will be 1 minute. Single set contains 10 repetitions in 1 minute with 30 seconds resting period between sets.
| Study group | Role | What they receive |
|---|---|---|
| Foam Rolling Group | Experimental | The participants in this group will receive foam rolling exercise. Receives: Other: Foam Rolling Exercise |
| Control Group | No intervention | The participants in this group will receive no foam rolling. They will only be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow Proprioception
Change of elbow joint position sense (with digital inclinometer in degree) and force match ( hand held dynamometer in kg )
Measured: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 month
Secondary outcomes (2)
Biceps Brachii Strength
Change of biceps brachii strength ( hand held dynamometer in kg )
Measured: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 month
Elbow Functional Motor Performance
Change of elbow functional motor performance (push up test, modified pull up test, closed kinetic chain upper extremity stability test )
Measured: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start25 Sep 2017
- Primary completion25 Nov 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups. Study group will receive foam rolling exercise. Control group will receive no foam rolling exercise. They will be handed a brochure about the proprioception and its role in injury prevention and foam rolling . Study group will be evaluated before foam rolling exercise . Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks. Control group will be evaluated for the first time. Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Özden, PT, Dokuz Eylul University
- Investigators
- Sevgi Sevi Yeşilyaprak, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312062
- Sponsor's protocol ID
- 3399-GOA
- Status last verified
- Feb 2019
- First submitted
- 28 Sep 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Foam Rolling on Elbow Proprioception, Strength, and Functional Motor Performance
- ClinicalTrials.gov ID
- NCT03312062
- Acronym / sponsor ID
- 3399-GOA
- Conditions
- Proprioceptive Disorders
- Keywords
- elbow, foam rolling, proprioception, motor performance, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 17 Oct 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.
The purpose of this study is to investigate the long-term effects of foam rolling on elbow proprioception, strength and functional motor performance with healthy participants . Study group will receive foam rolling exercise. Control group will receive no foam rolling exercise. Control group will be given a brochure including information about proprioception and foam rolling.
Detailed description
There is no information in literature about the effects of foam rolling on elbow proprioception, strength and functional motor performance. The purpose of this study is to investigate long-term effects of foam rolling with healthy participants. Study group will receive foam rolling exercise actively by themselves on elbow.
Foam rolling exercise will be applied 10 times each for 1 minute. These exercises will be performed as 2 sets. After each set will be a resting period for 30 seconds.A total of 12 sessions of exercise will be performed three times a week. Second evaluation will be performed after 4 weeks. Then the follow up evaluation (third evaluation) will be performed 4 weeks later. Control group will receive no foam rolling exercise. They will be handed a brochure about the proprioception and its role in injury prevention and foam rolling. Control group will be evaluated for the first time. Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are 2 groups. Study group will receive foam rolling exercise. Control group will receive no foam rolling exercise. They will be handed a brochure about the proprioception and its role in injury prevention and foam rolling . Study group will be evaluated before foam rolling exercise . Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks. Control group will be evaluated for the first time. Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks.
| Arm | Type | Receives |
|---|---|---|
| Foam Rolling Group | Experimental | Other: Foam Rolling ExerciseThe participants in this group will receive foam rolling exercise. |
| Control Group | No intervention | –The participants in this group will receive no foam rolling. They will only be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and above healthy participants
- No pain in elbow area within 6 months and at the time of measurement
- To be able to complete all evaluations and applications to be carried out
Key exclusion criteria (9 listed)
- Having previous foam rolling and self-myofascial relaxation applications on the target area
- Having acne and similar skin problems, open wounds
- Having upper extremity injury, history of fracture or surgery
- Having any systemic musculoskeletal disease
- Having diagnosis of diabetic mellitus or peripheral neuropathy
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 |
|---|---|---|
| Foam Rolling ExerciseFoam rolling exercise will be performed actively. Participants will use a foam roller for exercise. They will position the foam roller on the chair. Afterwards, they will use their body weights to rub the elbow area (biceps brachii muscle) with this foam. There will be 2 sets and each set will be 1 minute. Single set contains 10 repetitions in 1 minute with 30 seconds resting period between sets. | Other | Foam Rolling Group |
Primary outcome
Elbow Proprioception
Time frame: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 month
Change of elbow joint position sense (with digital inclinometer in degree) and force match ( hand held dynamometer in kg )
2 secondary outcomes
Biceps Brachii Strength
Time frame: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 month
Elbow Functional Motor Performance
Time frame: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 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 12 Feb 2019.
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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.
Sevgi Sevi Yeşilyaprak study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam Rolling Exercise in people with Proprioceptive Disorders, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 12 Feb 2019. 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 Turkey (Türkiye). 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?
Elbow Proprioception (time frame: Baseline, after 4 weeks foam rolling exercise period and then follow up measurement 1 month). 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 12 Feb 2019.