Postural BalanceNCT05190224
Changes in Plantar Preassures and Ankle Range of Motion After the Technique of Neuromeningeal Mobilization
A study testing Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves. in people with Postural Balance and Rehabilitation, run by Mayuben Private Clinic at 1 site in Spain.
Trial summary
Neuromeningeal mobilization or neurodynamics is a movement-based technique whose purpose is to restore peri- and intraneural homeostasis (1). It is based on principle that nerves have to lengthen and shorten to maintain normal muscle tension and range of motion (1) This technique has been shown to be effective in… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Rehabilitation, Foot
- What is being tested?
- Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2022to 6 Feb 2022
- 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
- -Participants who arrived at the clinic presenting with pain in both heels and who were diagnosed with active or latent MTrP in bilateral flexor digitorum brevis, (2) these specific MTrPs were the only MTrPs diagnosed in limb or foot, (3) all participants had a normal body mass because obesity can affect plantar pressure distribution [28], and (4) and had an age range of 27.96 to 36.04 (95% confidence interval [CI]) because body mass could also affect plantar pressures.
Who cannot join
- (1) Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligament injuries [27], (2) a history of previous lower extremity surgery [28], (3) participants were required not to have undergone ankle stretching or any other treatment [23], (4) diabetes due to possible elevation of plantar pressure, [30], (5) deformities of the toes, such as hammer toes and hallux valgus due to their possible alteration in plantar pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Plantar Pressures and Ankle Range of Motion After the Technique of Neuromeningeal Mobilization of the Posterior Tibial Nerve, Deep Peroneal Nerve, Medial and Lateral Dorsocutaneous Nerve
Neuromeningeal mobilization or neurodynamics is a movement-based technique whose purpose is to restore peri- and intraneural homeostasis (1). It is based on principle that nerves have to lengthen and shorten to maintain normal muscle tension and range of motion (1) This technique has been shown to be effective in recovering tissue mobility (2), reducing pain in low back pain (3) and neck pain (1) and pain intensity in the elderly, and increasing joint range of motion and muscle flexibility (4 )
Regarding balance, sciatic nerve sliding has been shown to immediately improve balance to one leg ( dinamic balance) after application in a comparative study before and after (4,5)
No study has been realised in for the Posterior Tibial, Deep Peroneal, Medial Dorsocutaneous and Lateral Nerves, and no study has verificated standing balance and range of motion in ankle joint
Read the detailed description
The study will consist of recording before and after applying the nerve mobilization exercise. Measurements will be made on the same day without the need to go at another time.
In this study, participants will be asked to stand on a pressure platform several times in a relaxed manner and with eyes open and closed before and after a neuromeningeal mobilization technique indicated for the treatment of pain in your feet. In addition, the mobility of the ankle will be measured with the knee flexed and stretched. The measurements or tests to be carried out are totally innocuous and do not carry any risk to your health and integrity.
Participants will have to remain barefoot for a maximum of 30 seconds, a total of 8 times on a pressure platform
- Conditions
- Postural Balance, Rehabilitation, Foot, Therapy
- Being tested
- Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves.
- Keywords
- Platform, neural movilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves.Other
In lateral decubitus the patient with the help of the clinician will perform neuromeningeal mobilization of the posterior tibial dorsocutaneous lateral, intermediate and medial nerves and deep peroneal nerve too.
| Study group | Role | What they receive |
|---|---|---|
| Experimental- | Experimental | All participants will be included in this arm Receives: Other: Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables of plantar pressures with platform before mobilization
During 30 seconds we will record the plantar pressure variables in grams per square centimeter
Measured: Through study completion, an average of 2 days
Variable footprint plantar surface with platform before
For 30 seconds we will record the area of the footprint in square centimeters.
Measured: Through study completion, an average of 2 days
Variables of plantar pressures with platform after mobilization
During 30 seconds we will record the plantar pressure variables in grams per square centimeter
Measured: Through study completion, an average of 2 days
Variable footprint plantar surface with platform after mobilization
For 30 seconds we will record the area of the footprint in square centimeters
Measured: Through study completion, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start27 Jan 2022
- Primary completion2 Feb 2022
- Study completion6 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayuben Private Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
- Investigators
- EVA Martínez-Jimenez, Dr, Principal investigator, Mayuben C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190224
- Sponsor's protocol ID
- 3010201915819
- Status last verified
- Jan 2022
- First submitted
- 28 Dec 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Plantar Pressures and Ankle Range of Motion After the Technique of Neuromeningeal Mobilization of the Posterior Tibial Nerve, Deep Peroneal Nerve, Medial and Lateral Dorsocutaneous Nerve
- ClinicalTrials.gov ID
- NCT05190224
- Acronym / sponsor ID
- 3010201915819
- Conditions
- Postural Balance, Rehabilitation, Foot, Therapy
- Keywords
- Platform, neural movilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 6 Feb 2022 (actual)
- First posted
- 13 Jan 2022 (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.
Neuromeningeal mobilization or neurodynamics is a movement-based technique whose purpose is to restore peri- and intraneural homeostasis (1). It is based on principle that nerves have to lengthen and shorten to maintain normal muscle tension and range of motion (1) This technique has been shown to be effective in recovering tissue mobility (2), reducing pain in low back pain (3) and neck pain (1) and pain intensity in the elderly, and increasing joint range of motion and muscle flexibility (4 )
Regarding balance, sciatic nerve sliding has been shown to immediately improve balance to one leg ( dinamic balance) after application in a comparative study before and after (4,5)
No study has been realised in for the Posterior Tibial, Deep Peroneal, Medial Dorsocutaneous and Lateral Nerves, and no study has verificated standing balance and range of motion in ankle joint
Detailed description
The study will consist of recording before and after applying the nerve mobilization exercise. Measurements will be made on the same day without the need to go at another time.
In this study, participants will be asked to stand on a pressure platform several times in a relaxed manner and with eyes open and closed before and after a neuromeningeal mobilization technique indicated for the treatment of pain in your feet. In addition, the mobility of the ankle will be measured with the knee flexed and stretched. The measurements or tests to be carried out are totally innocuous and do not carry any risk to your health and integrity.
Participants will have to remain barefoot for a maximum of 30 seconds, a total of 8 times on a pressure platform
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental- | Experimental | Other: Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves.All participants will be included in this arm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Participants who arrived at the clinic presenting with pain in both heels and who were diagnosed with active or latent MTrP in bilateral flexor digitorum brevis, (2) these specific MTrPs were the only MTrPs diagnosed in limb or foot, (3) all participants had a normal body mass because obesity can affect plantar pressure distribution [28], and (4) and had an age range of 27.96 to 36.04 (95% confidence interval [CI]) because body mass could also affect plantar pressures.
Key exclusion criteria (1 listed)
- (1) Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligament injuries [27], (2) a history of previous lower extremity surgery [28], (3) participants were required not to have undergone ankle stretching or any other treatment [23], (4) diabetes due to possible elevation of plantar pressure, [30], (5) deformities of the toes, such as hammer toes and hallux valgus due to their possible alteration in plantar pressure.
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 |
|---|---|---|
| Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves.In lateral decubitus the patient with the help of the clinician will perform neuromeningeal mobilization of the posterior tibial dorsocutaneous lateral, intermediate and medial nerves and deep peroneal nerve too. | Other | Experimental- |
Primary outcome
Variables of plantar pressures with platform before mobilization
Time frame: Through study completion, an average of 2 days
During 30 seconds we will record the plantar pressure variables in grams per square centimeter
Variable footprint plantar surface with platform before
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the area of the footprint in square centimeters.
Variables of plantar pressures with platform after mobilization
Time frame: Through study completion, an average of 2 days
During 30 seconds we will record the plantar pressure variables in grams per square centimeter
Variable footprint plantar surface with platform after mobilization
Time frame: Through study completion, an average of 2 days
For 30 seconds we will record the area of the footprint in square centimeters
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 8 Feb 2022.
- Individual participant dataSharing planned: No. There will be no sharing plan
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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.
EVA Martínez-Jimenez, Dr principal investigator
Mayuben C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves. in people with Postural Balance and Rehabilitation, run by Mayuben Private Clinic 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 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: finished, as of the sponsor's last update on 8 Feb 2022. 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?
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?
Variables of plantar pressures with platform before mobilization (time frame: Through study completion, an average of 2 days). The study lists 4 primary outcomes in all. 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 8 Feb 2022.