Lower Limb PronationNCT03312101
Exercise Program for Lower Limb Pronation
A study testing exercise program in people with Lower Limb Pronation, run by University of Seville at 1 site in Spain.
Trial summary
Introduction: The prevalence of biomechanical alterations in the the lower limbs in school-age children is increasing. The aim of this study is to assess the effectiveness of a therapeutic exercise program in child athletes with lower limb overpronation during gait. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Pronation
- What is being tested?
- exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 1 Jul 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being 9-12 years of age
- having being federated for at least two years (to be a member of the Andalusian Rugby Federation)
- training at least two hours three days a week;
- having lower limb overpronation (Fick angle <12º, femorotibial angle <170º and Helbing angle <175º)
Who cannot join
- lower limb asymmetry
- biomechanical alteration secondary to an acute disorder
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Gabriel Domínguez-Maldonado
Seville, 41009
Gabriel D Maldonado, PhD, 665329628, gdominguez@us.es
About this study
Official title: Clinical Trail of Therapeutic Physical Exercise for Lower Limb Overpronation in Rugby Young Players
Introduction: The prevalence of biomechanical alterations in the the lower limbs in school-age children is increasing. The aim of this study is to assess the effectiveness of a therapeutic exercise program in child athletes with lower limb overpronation during gait.
Methods: Relevant databases (PubMed and SCOPUS) were searched. A total of 123 young athletes (aged 9-12 years) will be evaluated. Subjects will be tested biomechanical analysis including all relevant angles, as follows: the Helbing angle, the femorotibial angle, and the Fick angle in both limbs. Subjects will be divided into two groups at random. Children in experimental group will participate in an exercise program for three months. Children in control group will not received treatment for three months. After the study, these children will receive the same treatment as children in experimental group.
Read the detailed description
Firstly, a biomechanical analysis of gait will be performed at CAMD, using a modular electronic baropodometer (Diagnostic Support Walk®), Milletrix Applicazione MFC® (Diasu, Italia) and a video camera (Diagnostic Support S.R.L., Diasu, Italy). We will measure the parameters characterizing lower limb overpronation. The parameters measured during walking will be: Fick angle, femorotibial angle and Helbing angle. Skin Surface markers on anatomical references were placed to measure femorotibial and Helbing angle. To measure the Fick angle we will take a footprint.
Children in the experimental group will be treated with functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle.
The selection of the prescribed exercises will be performed according to the principal activity of different muscles and functional impact on the gait. Previous experiences in implementing this exercises program has shown us positive results after three months of application. That is why this temporary intervention for the period was determined.
Parents of children will be instructed to monitor the exercises. They will be given a timetable for controlling autonomous treatment sessions, as well as the dates of the revisions with the evaluator. These reviews will be conducted every 15 days, analyzing the evolution of musculoskeletal disorders, and, if necessary, modifications will be applied in the exercise program.
After three months, a new evaluation will be performed in the same manner as the initial assessment. The purpose of this evaluation is to determine the existence or not of changes in biomechanical parameters studied due the exercices program application.
- Conditions
- Lower Limb Pronation
- Being tested
- exercise program
- Keywords
- exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise programOther
functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle,
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | exercise program Receives: Other: exercise program |
| Control | No intervention | observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower limb pronation reduction
anthropometric parameters (Fick angle)
Measured: 3 months
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 start1 Jun 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb PronationStudies 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
- Parallel asigmanet
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Domínguez-Maldonado, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312101
- Sponsor's protocol ID
- pornation lower limb
- Status last verified
- May 2018
- First submitted
- 19 Sep 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trail of Therapeutic Physical Exercise for Lower Limb Overpronation in Rugby Young Players
- ClinicalTrials.gov ID
- NCT03312101
- Acronym / sponsor ID
- pornation lower limb
- Conditions
- Lower Limb Pronation
- Keywords
- exercise program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- 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.
Introduction: The prevalence of biomechanical alterations in the the lower limbs in school-age children is increasing. The aim of this study is to assess the effectiveness of a therapeutic exercise program in child athletes with lower limb overpronation during gait.
Methods: Relevant databases (PubMed and SCOPUS) were searched. A total of 123 young athletes (aged 9-12 years) will be evaluated. Subjects will be tested biomechanical analysis including all relevant angles, as follows: the Helbing angle, the femorotibial angle, and the Fick angle in both limbs. Subjects will be divided into two groups at random. Children in experimental group will participate in an exercise program for three months. Children in control group will not received treatment for three months. After the study, these children will receive the same treatment as children in experimental group.
Detailed description
Firstly, a biomechanical analysis of gait will be performed at CAMD, using a modular electronic baropodometer (Diagnostic Support Walk®), Milletrix Applicazione MFC® (Diasu, Italia) and a video camera (Diagnostic Support S.R.L., Diasu, Italy). We will measure the parameters characterizing lower limb overpronation. The parameters measured during walking will be: Fick angle, femorotibial angle and Helbing angle. Skin Surface markers on anatomical references were placed to measure femorotibial and Helbing angle. To measure the Fick angle we will take a footprint.
Children in the experimental group will be treated with functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle.
The selection of the prescribed exercises will be performed according to the principal activity of different muscles and functional impact on the gait. Previous experiences in implementing this exercises program has shown us positive results after three months of application. That is why this temporary intervention for the period was determined.
Parents of children will be instructed to monitor the exercises. They will be given a timetable for controlling autonomous treatment sessions, as well as the dates of the revisions with the evaluator. These reviews will be conducted every 15 days, analyzing the evolution of musculoskeletal disorders, and, if necessary, modifications will be applied in the exercise program.
After three months, a new evaluation will be performed in the same manner as the initial assessment. The purpose of this evaluation is to determine the existence or not of changes in biomechanical parameters studied due the exercices program application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel asigmanet
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: exercise programexercise program |
| Control | No intervention | –observation |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- being 9-12 years of age
- having being federated for at least two years (to be a member of the Andalusian Rugby Federation)
- training at least two hours three days a week;
- having lower limb overpronation (Fick angle <12º, femorotibial angle <170º and Helbing angle <175º)
Key exclusion criteria (2 listed)
- lower limb asymmetry
- biomechanical alteration secondary to an acute disorder
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 |
|---|---|---|
| exercise programfunctional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle, | Other | Experimental |
Primary outcome
lower limb pronation reduction
Time frame: 3 months
anthropometric parameters (Fick angle)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise program in people with Lower Limb Pronation, run by University of Seville at 1 site in Spain.
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 4 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 2 May 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 Spain. 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 Gabriel Domínguez-Maldonado, PhD (0034665329628, gdominguez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower limb pronation reduction (time frame: 3 months). 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 2 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.