Lumbar Spine InstabilityNCT03359083
Relationship Between Foot-ankle Characteristics and Lumbopelvic Control, Balance and Physical Performance
An observational study of Lumbar Spine Instability and Balance, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
It has been shown that foot and ankle postural disorders can alter the biomechanic of lower extremity and pelvis. This situation can affects balance, postural control and phsical performance of individual adversely. However, it is unknown whether the muscles that control lumbopelvic are affected or not affected. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Instability, Balance, Physical Performance
- What is being tested?
- Correlation
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2017to 20 Jan 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 64 healthy young adults
Who may be able to join
- Volunteering to participate.
- Be between the ages of 18 and 25
- Being a normal weighted individual with a body mass index from 18.5 to 24.9
Who cannot join
- Presence of any systemic, locomotive or foot related problem
- Undergone any surgical operation related to the foot
- To have loss of sense, diabetic or peripheral neuropathy
- The presence of any problem with the spine (back pain, scoliosis, past surgeons)
- Presence of any neurological problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Foot-ankle Characteristics and Lumbopelvic Control, Balance and Physical Performance in Healthy Young Adults.
It has been shown that foot and ankle postural disorders can alter the biomechanic of lower extremity and pelvis. This situation can affects balance, postural control and phsical performance of individual adversely. However, it is unknown whether the muscles that control lumbopelvic are affected or not affected. The aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.
Read the detailed description
A healthy load distribution at the foot depends on the ability of the foot to fulfill both the task of stabilization and mobilization. Studies related foot movement disorders usually focus on subtalar joint. The reason for this is that subtalar joint transmits the rotations which in leg to the foot. One of the deformities affecting the foot and subtalar joint is pes planus. Kosashvili et al. have shown that grade 2 and 3 pes planus can affect the lower limb biomechanical alignment, resulting in an increase in perceived pain associated with the knee, hip and pelvic region. Problems related to foot and ankle can affect the balance of individuals as well as affect the pelvic region. Sung et al. have shown that the postural stability and balance of individuals with pes planus are worse than those without pes planus. Studies showing that foot-ankle postural disorders negatively affect physical fitness and motor performance of individuals are also present. Akaras et al. have stated that the increase in pronation in the hindfoot affects individuals' leap and agility performance negatively. It has shown that leg-related problems can affect upper. However, there is no objective study of ultrasonographic imaging of core muscles in foot-ankle problems. The aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.
- Conditions
- Lumbar Spine Instability, Balance, Physical Performance, Foot, Ankle Deformity
- Being tested
- Correlation
- Keywords
- foot-ankle characteristic, lumbopelvic control, balance, physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorrelationOther
Correlation between assesment parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
INVESTIGATION OF THE RELATIONSHIP BETWEEN FOOT-ANKLE CHARACTERISTICS AND LUMBOPELVIC CONTROL, BALANCE AND PHYSICAL PERFORMANCE IN HEALTHY YOUNG ADULTS
Adverse changes in foot-ankle characteristics in healthy young adults affect lumbopelvic control, balance and phsical performance adversely.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start20 Nov 2017
- Primary completion20 Dec 2017 (estimated)
- Study completion20 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine InstabilityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359083
- Sponsor's protocol ID
- 2017200
- Status last verified
- Nov 2017
- First submitted
- 27 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6.
PubMed 18822155Richardson CA, Snijders CJ, Hides JA, Damen L, Pas MS, Storm J. The relation between the transversus abdominis muscles, sacroiliac joint mechanics, and low back pain. Spine (Phila Pa 1976). 2002 Feb 15;27(4):399-405. doi: 10.1097/00007632-200202150-00015.
PubMed 11840107Pinto RZ, Souza TR, Trede RG, Kirkwood RN, Figueiredo EM, Fonseca ST. Bilateral and unilateral increases in calcaneal eversion affect pelvic alignment in standing position. Man Ther. 2008 Dec;13(6):513-9. doi: 10.1016/j.math.2007.06.004. Epub 2007 Oct 1.
PubMed 17910932
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Foot-ankle Characteristics and Lumbopelvic Control, Balance and Physical Performance in Healthy Young Adults.
- ClinicalTrials.gov ID
- NCT03359083
- Acronym / sponsor ID
- 2017200
- Conditions
- Lumbar Spine Instability, Balance, Physical Performance, Foot, Ankle Deformity
- Keywords
- foot-ankle characteristic, lumbopelvic control, balance, physical performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 20 Jan 2018 (estimated)
- First posted
- 2 Dec 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.
It has been shown that foot and ankle postural disorders can alter the biomechanic of lower extremity and pelvis. This situation can affects balance, postural control and phsical performance of individual adversely. However, it is unknown whether the muscles that control lumbopelvic are affected or not affected. The aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.
Detailed description
A healthy load distribution at the foot depends on the ability of the foot to fulfill both the task of stabilization and mobilization. Studies related foot movement disorders usually focus on subtalar joint. The reason for this is that subtalar joint transmits the rotations which in leg to the foot. One of the deformities affecting the foot and subtalar joint is pes planus. Kosashvili et al. have shown that grade 2 and 3 pes planus can affect the lower limb biomechanical alignment, resulting in an increase in perceived pain associated with the knee, hip and pelvic region. Problems related to foot and ankle can affect the balance of individuals as well as affect the pelvic region. Sung et al. have shown that the postural stability and balance of individuals with pes planus are worse than those without pes planus. Studies showing that foot-ankle postural disorders negatively affect physical fitness and motor performance of individuals are also present. Akaras et al. have stated that the increase in pronation in the hindfoot affects individuals' leap and agility performance negatively. It has shown that leg-related problems can affect upper. However, there is no objective study of ultrasonographic imaging of core muscles in foot-ankle problems. The aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 64 healthy young adults
Key inclusion criteria (3 listed)
- Volunteering to participate.
- Be between the ages of 18 and 25
- Being a normal weighted individual with a body mass index from 18.5 to 24.9
Key exclusion criteria (5 listed)
- Presence of any systemic, locomotive or foot related problem
- Undergone any surgical operation related to the foot
- To have loss of sense, diabetic or peripheral neuropathy
- The presence of any problem with the spine (back pain, scoliosis, past surgeons)
- Presence of any neurological problem
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 |
|---|---|---|
| CorrelationCorrelation between assesment parameters | Other | – |
Primary outcome
INVESTIGATION OF THE RELATIONSHIP BETWEEN FOOT-ANKLE CHARACTERISTICS AND LUMBOPELVIC CONTROL, BALANCE AND PHYSICAL PERFORMANCE IN HEALTHY YOUNG ADULTS
Time frame: 2 months
Adverse changes in foot-ankle characteristics in healthy young adults affect lumbopelvic control, balance and phsical performance adversely.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Background: PubMed 18822155Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6.
- Background: PubMed 11840107Richardson CA, Snijders CJ, Hides JA, Damen L, Pas MS, Storm J. The relation between the transversus abdominis muscles, sacroiliac joint mechanics, and low back pain. Spine (Phila Pa 1976). 2002 Feb 15;27(4):399-405. doi: 10.1097/00007632-200202150-00015.
- Background: PubMed 17910932Pinto RZ, Souza TR, Trede RG, Kirkwood RN, Figueiredo EM, Fonseca ST. Bilateral and unilateral increases in calcaneal eversion affect pelvic alignment in standing position. Man Ther. 2008 Dec;13(6):513-9. doi: 10.1016/j.math.2007.06.004. Epub 2007 Oct 1.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Lumbar Spine Instability and Balance, run by Hacettepe 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 5 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 4 Dec 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 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?
Results are not available in the source record.
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?
INVESTIGATION OF THE RELATIONSHIP BETWEEN FOOT-ANKLE CHARACTERISTICS AND LUMBOPELVIC CONTROL, BALANCE AND PHYSICAL PERFORMANCE IN HEALTHY YOUNG ADULTS (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359083, which also lists 3 linked publications.
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 4 Dec 2017.