ExerciseNCT03916991
Effect of Hip-focused Neuromuscular Activation Exercise on Foot Posture and Neuromuscular Control
A study testing Exercise in people with Exercise, run by Hacettepe University.
Trial summary
This study planned to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control in symptomatic and asymptomatic participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2019to 12 Jul 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included, participants should be between the ages of 18 and 45 years.
Who cannot join
- Participants will be excluded from this study if they have a history of lower body trauma or surgery, or positive trendelenburg sign and slump test.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Cross-over Study to Investigate the Effect of Hip-focused Neuromuscular Activation Exercise on Foot Posture and Neuromuscular Control
This study planned to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control in symptomatic and asymptomatic participants. We will follow a cross-over study design to compare the effect of hip focused neuromuscular activation exercise or a sham exercise on foot posture and lower extremity biomechanics. Foot posture will be assessed by Navicular Drop Test (NDT), and lower extremity neuromuscular control will be assessed with Star Excursion Y-Balance Test (SEBT-Y) and Frontal Plane Projection Angle (FPPA) during single leg squat before and after the experiments. The results of this study may provide scientific knowledge for a kinetic chain approach during functional foot rehabilitation.
- Conditions
- Exercise
- Being tested
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Hip focused Neuromuscular Activation Exercise
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Exercise | Experimental | Neuromuscular Exercise Receives: Other: Exercise |
| Control | No intervention | No intervention |
| Sham Exercise | Sham comparator | Sham Exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop Test
Navicular Drop Test
Measured: 1 year
Secondary outcomes (2)
Star Excursion Y-Balance Test
Star Excursion Y-Balance Test
Measured: 1 year
Frontal Plane Projection Angle
Frontal Plane Projection Angle
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start12 Apr 2019 (estimated)
- Primary completion12 Jun 2019 (estimated)
- Study completion12 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cross-over study to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Turgut, Hacettepe University
- Investigators
- Elif Turgut, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916991
- Sponsor's protocol ID
- GO16542
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- 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 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Study to Investigate the Effect of Hip-focused Neuromuscular Activation Exercise on Foot Posture and Neuromuscular Control
- ClinicalTrials.gov ID
- NCT03916991
- Acronym / sponsor ID
- GO16542
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Apr 2019 (estimated)
- Primary completion
- 12 Jun 2019 (estimated)
- Study completion
- 12 Jul 2019 (estimated)
- First posted
- 16 Apr 2019 (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.
This study planned to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control in symptomatic and asymptomatic participants. We will follow a cross-over study design to compare the effect of hip focused neuromuscular activation exercise or a sham exercise on foot posture and lower extremity biomechanics. Foot posture will be assessed by Navicular Drop Test (NDT), and lower extremity neuromuscular control will be assessed with Star Excursion Y-Balance Test (SEBT-Y) and Frontal Plane Projection Angle (FPPA) during single leg squat before and after the experiments. The results of this study may provide scientific knowledge for a kinetic chain approach during functional foot rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A cross-over study to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Exercise | Experimental | Other: ExerciseNeuromuscular Exercise |
| Control | No intervention | –No intervention |
| Sham Exercise | Sham comparator | Other: ExerciseSham Exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be included, participants should be between the ages of 18 and 45 years.
Key exclusion criteria (1 listed)
- Participants will be excluded from this study if they have a history of lower body trauma or surgery, or positive trendelenburg sign and slump test.
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 |
|---|---|---|
| ExerciseHip focused Neuromuscular Activation Exercise | Other | Neuromuscular Exercise, Sham Exercise |
Primary outcome
Navicular Drop Test
Time frame: 1 year
Navicular Drop Test
2 secondary outcomes
Star Excursion Y-Balance Test
Time frame: 1 year
Frontal Plane Projection Angle
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- 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.
Elif Turgut, PhD principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise, run by Hacettepe University.
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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Elif Turgut, PhD (00903123051576, elifcamci@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop Test (time frame: 1 year). 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 Apr 2019.