Foot DiseasesNCT03117244
The Effectiveness of a Protocol for Muscular Foot Strengthening On a Capacity to Control the Deformation of the DOT Plantar Medial
A study testing Exercise for Foot Strengthening and Exercise for Foot Strengthening and Electrostimulation in people with Foot Diseases, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
The human foot allows to perform several functions, rather than providing a Static support for the body, the foot acts dynamically in walking and Movement of the body, requiring adequate biomechanics responsible for Maintenance and posture of the body and harmonic distribution of plantar pressure. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Diseases
- What is being tested?
- Exercise for Foot Strengthening and Exercise for Foot Strengthening and Electrostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2016to 10 Apr 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between the ages of 18 and 40,
- Seeders (do not practice physical activity regularly)
- No previous injuries to the feet and ankles,
- 12 months without lesions in lower members,
- Without deformities in APM,
- Such as, rigid planar foot
- No history of neurological changes
Who cannot join
- Individuals who practice physical activities regularly,
- History of pain in the feet,
- Have suffered fractures in the lower limbs,
- Muscular and articular lesions of Lower members in 12 months, -
- Flat foot,
- Valgus of calcaneus above 10º
- History of neurological changes or surgical procedure performed on lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Protocol for Muscular Foot Strengthening On a Capacity to Control the Deformation of the DOT Plantar Medial
The human foot allows to perform several functions, rather than providing a Static support for the body, the foot acts dynamically in walking and Movement of the body, requiring adequate biomechanics responsible for Maintenance and posture of the body and harmonic distribution of plantar pressure.
One of the most important structures for this control is the medial plantar vault (MPA), an important structure in the absorption of impact and essential for the function Foot. The deformation of the MPA in the gait support phase absorbs the Energy and propels the limb, to perform this biomechanical function the MPA must Stable from the anatomical point of view, which is conferred by the bone architecture and But also by the performance of the intrinsic and extrinsic musculature of the Feet. The fall of the MPA, decreases the stability of the foot, limits its biomechanical function,
Read more
Besides being a risk factor for the development of pathologies such as:
Tendinopathy of the calcaneus tendon and plantar fasciitis. Various Intrinsic Muscles And extrinsic have the function of stabilizing the foot and the MPA, being the main Extrinsic muscles: the posterior tibial, the flexor long of the hallux and the fingers. The Muscles when activated increase the height and decrease the Length of the MPA. Several methods are used to evaluate ALM, such as (AN), Feiss line (LF) and MPA angle (MPAH), in addition to the Baropodometry, which is used to evaluate dysfunctions in the feet, with the principle of Map the pressure of the plantar surface in a static and dynamic way. Based In this information, this study aims to evaluate the influence of the Strengthening of the intrinsic and extrinsic muscles of the feet, for the Of MPA in asymptomatic patients.
- Conditions
- Foot Diseases
- Being tested
- Exercise for Foot Strengthening, Exercise for Foot Strengthening and Electrostimulation
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise for Foot StrengtheningOther
Stabilization exercises of the longitudinal arch of the foot
Exercise for Foot Strengthening and ElectrostimulationOther
Exercise for the Strengthening of the Foot associated with Electrostimulation
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Not described Receives: Other: Exercise for Foot Strengthening |
| Exercise and NMES Group | Active comparator | Not described Receives: Other: Exercise for Foot Strengthening and Electrostimulation |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the medial longitudinal arch
Navicular height Angle of the medial longitudinal arch Feiss line
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start12 Dec 2016
- Primary completion2 Jan 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117244
- Sponsor's protocol ID
- 62766716.4.0000.5479
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for Muscular Foot Strengthening On a Capacity to Control the Deformation of the DOT Plantar Medial
- ClinicalTrials.gov ID
- NCT03117244
- Acronym / sponsor ID
- 62766716.4.0000.5479
- Conditions
- Foot Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 17 Apr 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 human foot allows to perform several functions, rather than providing a Static support for the body, the foot acts dynamically in walking and Movement of the body, requiring adequate biomechanics responsible for Maintenance and posture of the body and harmonic distribution of plantar pressure.
One of the most important structures for this control is the medial plantar vault (MPA), an important structure in the absorption of impact and essential for the function Foot. The deformation of the MPA in the gait support phase absorbs the Energy and propels the limb, to perform this biomechanical function the MPA must Stable from the anatomical point of view, which is conferred by the bone architecture and But also by the performance of the intrinsic and extrinsic musculature of the Feet. The fall of the MPA, decreases the stability of the foot, limits its biomechanical function,
Besides being a risk factor for the development of pathologies such as:
Tendinopathy of the calcaneus tendon and plantar fasciitis. Various Intrinsic Muscles And extrinsic have the function of stabilizing the foot and the MPA, being the main Extrinsic muscles: the posterior tibial, the flexor long of the hallux and the fingers. The Muscles when activated increase the height and decrease the Length of the MPA. Several methods are used to evaluate ALM, such as (AN), Feiss line (LF) and MPA angle (MPAH), in addition to the Baropodometry, which is used to evaluate dysfunctions in the feet, with the principle of Map the pressure of the plantar surface in a static and dynamic way. Based In this information, this study aims to evaluate the influence of the Strengthening of the intrinsic and extrinsic muscles of the feet, for the Of MPA in asymptomatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise for Foot Strengthening |
| Exercise and NMES Group | Active comparator | Other: Exercise for Foot Strengthening and Electrostimulation |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals between the ages of 18 and 40,
- Seeders (do not practice physical activity regularly)
- No previous injuries to the feet and ankles,
- 12 months without lesions in lower members,
- Without deformities in APM,
Key exclusion criteria (7 listed)
- Individuals who practice physical activities regularly,
- History of pain in the feet,
- Have suffered fractures in the lower limbs,
- Muscular and articular lesions of Lower members in 12 months, -
- Flat foot,
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 for Foot StrengtheningStabilization exercises of the longitudinal arch of the foot | Other | Exercise Group |
| Exercise for Foot Strengthening and ElectrostimulationExercise for the Strengthening of the Foot associated with Electrostimulation | Other | Exercise and NMES Group |
Primary outcome
Measurements of the medial longitudinal arch
Time frame: 6 weeks
Navicular height Angle of the medial longitudinal arch Feiss line
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 25 Apr 2019.
Related trials for Foot Diseases
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Recruiting
Effectiveness of Pulsed Electromagnetic Field Therapy in Patients With Symptomatic Plantar Calcaneal Spurs
Calcaneal Spur
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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?
A study testing Exercise for Foot Strengthening and Exercise for Foot Strengthening and Electrostimulation in people with Foot Diseases, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 7 inclusion and 7 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 25 Apr 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 Brazil. 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?
Measurements of the medial longitudinal arch (time frame: 6 weeks). 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 25 Apr 2019.