Pronation; AnkleNCT03557866
Kinematic Parameters of Running in Individuals With Pronated Foot
A study testing running in people with Pronation; Ankle, run by University of Haifa at 1 site in Israel.
Trial summary
The aim of the study is to examine the kinematic parameters of individuals with pronated foot compared with individuals with normal foot Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pronation; Ankle
- What is being tested?
- running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jun 2018to 1 Nov 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- running on a daily basis at least 3 times per week with minimum of 1 hour
- capable to run 5 km in less then 40 minutes
- willing to participate in the study
Who cannot join
- previous surgery in lower extremities
- Achilles tendon pain during the last year
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to examine the kinematic parameters of individuals with pronated foot compared with individuals with normal foot
Read the detailed description
Individual with and without pronated foot will be recruited. Pronation will be defined according to navicular drop test. Inclusion criteria : individual who run on a regular basis at least 3 times per week for one hour, can run 5 Km in less then 40 minutes, without past injuries during the last year of Achilles tendon or other lower extremities pain.
Individuals will be asked to run for 5 Km in self selected velocity. The Milestone pod device will be used to monitor kinematic parameters.
functional test will be conducted before and after the running as follows: heel raise test and one leg hop for distance test.
- Conditions
- Pronation; Ankle
- Being tested
- running
- Keywords
- foot posture, running, foot index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
runningDiagnostic test
Also called kinematic parameters of running
individuals will be asked to run for 5 km in self selected speed
| Study group | Role | What they receive |
|---|---|---|
| pronated group | Experimental | individuals with pronated foot Receives: Diagnostic Test: running |
| control group | Active comparator | individuals with normal foot posture Receives: Diagnostic Test: running |
What is being measured
The primary outcome is the main question the study is designed to answer.
stride length
stride length in cm
Measured: up to 6 months
cadence
steps per minute
Measured: up to 6 months
Secondary outcomes (2)
velocity
running velocity in Km/hour
Measured: up to 6 months
heel raise test
how many good heel raise till fatigue
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start22 Jun 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pronation; AnkleStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups. Individuals with and without pronated foot.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gali Dar, University of Haifa
- Investigators
- Gali Dar, PHd, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557866
- Sponsor's protocol ID
- 380/17
- Status last verified
- Nov 2018
- First submitted
- 4 Jun 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the results of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol and results
Publications
McPoil TG, Cornwall MW, Medoff L, Vicenzino B, Fosberg KK, Hilz D. Arch height change during sit-to-stand: an alternative for the navicular drop test. J Foot Ankle Res. 2009 May 18;2:17. doi: 10.1186/1757-1146-2-17.
PubMed 19450247Murley GS, Menz HB, Landorf KB. Foot posture influences the electromyographic activity of selected lower limb muscles during gait. J Foot Ankle Res. 2009 Nov 26;2:35. doi: 10.1186/1757-1146-2-35.
PubMed 19939283
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Parameters of Running in Individuals With Pronated Foot
- ClinicalTrials.gov ID
- NCT03557866
- Acronym / sponsor ID
- 380/17
- Conditions
- Pronation; Ankle
- Keywords
- foot posture, running, foot index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 15 Jun 2018 (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 aim of the study is to examine the kinematic parameters of individuals with pronated foot compared with individuals with normal foot
Detailed description
Individual with and without pronated foot will be recruited. Pronation will be defined according to navicular drop test. Inclusion criteria : individual who run on a regular basis at least 3 times per week for one hour, can run 5 Km in less then 40 minutes, without past injuries during the last year of Achilles tendon or other lower extremities pain.
Individuals will be asked to run for 5 Km in self selected velocity. The Milestone pod device will be used to monitor kinematic parameters.
functional test will be conducted before and after the running as follows: heel raise test and one leg hop for distance test.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups. Individuals with and without pronated foot.
| Arm | Type | Receives |
|---|---|---|
| pronated group | Experimental | Diagnostic Test: runningindividuals with pronated foot |
| control group | Active comparator | Diagnostic Test: runningindividuals with normal foot posture |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- running on a daily basis at least 3 times per week with minimum of 1 hour
- capable to run 5 km in less then 40 minutes
- willing to participate in the study
Key exclusion criteria (2 listed)
- previous surgery in lower extremities
- Achilles tendon pain during the last year
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 |
|---|---|---|
| runningAlso: kinematic parameters of runningindividuals will be asked to run for 5 km in self selected speed | Diagnostic test | control group, pronated group |
Primary outcome
stride length
Time frame: up to 6 months
stride length in cm
cadence
Time frame: up to 6 months
steps per minute
2 secondary outcomes
velocity
Time frame: up to 6 months
heel raise test
Time frame: up to 6 months
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 27 Nov 2018.
- Results publication: PubMed 19450247McPoil TG, Cornwall MW, Medoff L, Vicenzino B, Fosberg KK, Hilz D. Arch height change during sit-to-stand: an alternative for the navicular drop test. J Foot Ankle Res. 2009 May 18;2:17. doi: 10.1186/1757-1146-2-17.
- Results publication: PubMed 19939283Murley GS, Menz HB, Landorf KB. Foot posture influences the electromyographic activity of selected lower limb muscles during gait. J Foot Ankle Res. 2009 Nov 26;2:35. doi: 10.1186/1757-1146-2-35.
- Individual participant dataSharing planned: Yes. the results of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol and results
Related trials for Pronation; Ankle
Not yet recruiting
Hamsrting Stretching on Dynamic Balance, Foot Posture and Function in Pronated Feet.
Pronation; Ankle
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.
Gali Dar, PHd principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing running in people with Pronation; Ankle, run by University of Haifa 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 3 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: finished, as of the sponsor's last update on 27 Nov 2018. 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?
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?
stride length (time frame: up to 6 months). 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?
On the ClinicalTrials.gov record for NCT03557866, which also lists 2 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 27 Nov 2018.