HealthySM01NCT05080036
Muscle Activation of the Lower Limb in Response to a Medio-lateral Imbalance in Monopodal Stance
A study testing Medio-lateral imbalance in people with Healthy, run by Manusapiens at 1 site in Italy.
Trial summary
The "static" single-leg stance has been extensively studied in the literature for its relevance in functional evaluation, therapeutic exercise, sports training and research for fall prevention (particularly for the elderly and patients with neurological diseases). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Medio-lateral imbalance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2021to 30 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All healthy subjects
Who cannot join
- skeletal pathologies compromising balance
- neuromotor pathologies compromising balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Activation of the Lower Limb in Healthy Subjects in Response to a Medio-lateral Imbalance in Monopodal Stance: a Preliminary Study
The "static" single-leg stance has been extensively studied in the literature for its relevance in functional evaluation, therapeutic exercise, sports training and research for fall prevention (particularly for the elderly and patients with neurological diseases). However, the motor strategies of the supporting limb have been investigated only at the ankle level. In particular it is not known, at the hip, how the muscular system reacts to medial and lateral imbalances. Colonna has hypothesized, basing on a myofascial chains approach, that the balance is managed by the front and back spiral chains. The aim of the present study is to perform a preliminary experimental analysis to verify Colonna's hypothesis, testing a method for the investigation of motor strategies underlying equilibrium.
Five healthy subjects will be examined by means of electromyographic analysis of the gluteus maximus, gluteus medius, adductor longus, tibialis anterior and peroneus longus. Subjects will undergo perturbations of their monopodal balance.
Read the detailed description
The subjects involved in the research will be analyzed at the LAMBDA laboratory (UDGEE), AUSL-IRCCS (Azienda Unità Sanitaria Locale-Istituto di Ricovero e Cura a Carattere Scientifico) di Reggio Emilia.
The analysis will be carried out on the right lower limb of each subject. The electromyographic devices will be applied to the tibialis anterior, peroneus longus, gluteus medius, gluteus maximus and adductor longus.
Reflective markers will then be applied (using double-sided tape) according to the Total3DGait protocol, which identifies the body segments of the forearms, arms, trunk, pelvis, thighs, legs, and feet.
The subject must position himself with his right foot on a force platform. The toe of the left foot will be allowed to rest on the ground (on the other power platform posteriorly placed), with the verbal indication to load as little weight as possible on it: this indication is aimed at reducing muscle activation in the absence of external perturbations, in order to highlight only the activity caused by the perturbations themselves. Only acquisitions in which the load on the left foot will be less than 30% of the weight will be considered valid.
The hands will be placed on the hips to limit the variables to be controlled and to standardize the posture, in order to focus the contribution to the balance of the lower limb. The left thigh has to be kept vertical. Finally, it will be required to find, within the constraints described above, the posture that is as comfortable as possible, with minimal muscle contraction. The distance between the feet is therefore freely chosen by each subject.
The operator positions himself behind the subject to be examined, and without being seen performs lateral thrusts with the medial margin of the hand at the proximal third of the thigh. At least ten pushes per side will be performed, with random timing. The thrusts will be quick but without causing pain.
The operator will then request maximal contractions from the subject, in order to normalize the electrical activity of each muscle with respect to its maximum. It will be required to perform the dorsiflexion and pronation of the foot against resistance, then the adduction, abduction and extension of the hip.
- Conditions
- Healthy
- Being tested
- Medio-lateral imbalance
- Keywords
- human balance, monopodal stance, electromyography, myofascial chains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medio-lateral imbalanceOther
Thrust on the pelvis in the medio-lateral direction in order to create a balance perturbation
| Study group | Role | What they receive |
|---|---|---|
| Unbalanced healthy subjects | Experimental | Subjects undergo an external perturbation of their balance Receives: Other: Medio-lateral imbalance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum electrical intensity during early response of muscle activation
The muscles considered will be, for the anterior spiral chain, the adductor longus and the peroneus longus, for the posterior spiral chain, the glutei (medius and maximus) and the tibialis anterior. For each muscle, the intensity will be normalized to the intensity of the maximal contraction. Muscle activity will be evaluated for 1500ms, 500ms before and 1000ms after the thrust. The early response to the stimulus will be identified in the interval of 100-500ms after the thrust.The thrusts will be performed 10 times towards the medial direction and 10 towards the lateral. The median intensity for each direction will be calculated.
Measured: During the procedure
Correlation of muscle activity
Correlation coefficients of the activation intensity between each muscle of the hip and each muscle of the ankle: tibialis anterior-glutei; tibialis anterior-adductor longus; peroneus longus-glutei; peroneus longus-adductor longus. Calculated for each imbalance direction.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Aug 2021
- Primary completion1 Nov 2021
- Study completion30 Dec 2021
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 HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manusapiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080036
- Sponsor's protocol ID
- 957/2020/SPER/AUSLRE
- Acronym
- SM01
- Status last verified
- Oct 2021
- First submitted
- 26 Aug 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colonna S., 2012. Le catene miofasciali in medicina manuale - Arto inferiore: Ginocchio, Ed. Martina.
Morey-Klapsing G, Arampatzis A, Bruggemann GP. Joint stabilising response to lateral and medial tilts. Clin Biomech (Bristol). 2005 Jun;20(5):517-25. doi: 10.1016/j.clinbiomech.2005.01.008.
PubMed 15836939
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activation of the Lower Limb in Healthy Subjects in Response to a Medio-lateral Imbalance in Monopodal Stance: a Preliminary Study
- ClinicalTrials.gov ID
- NCT05080036
- Acronym / sponsor ID
- SM01 / 957/2020/SPER/AUSLRE
- Conditions
- Healthy
- Keywords
- human balance, monopodal stance, electromyography, myofascial chains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ManusapiensUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 15 Oct 2021 (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 "static" single-leg stance has been extensively studied in the literature for its relevance in functional evaluation, therapeutic exercise, sports training and research for fall prevention (particularly for the elderly and patients with neurological diseases). However, the motor strategies of the supporting limb have been investigated only at the ankle level. In particular it is not known, at the hip, how the muscular system reacts to medial and lateral imbalances. Colonna has hypothesized, basing on a myofascial chains approach, that the balance is managed by the front and back spiral chains. The aim of the present study is to perform a preliminary experimental analysis to verify Colonna's hypothesis, testing a method for the investigation of motor strategies underlying equilibrium.
Five healthy subjects will be examined by means of electromyographic analysis of the gluteus maximus, gluteus medius, adductor longus, tibialis anterior and peroneus longus. Subjects will undergo perturbations of their monopodal balance.
Detailed description
The subjects involved in the research will be analyzed at the LAMBDA laboratory (UDGEE), AUSL-IRCCS (Azienda Unità Sanitaria Locale-Istituto di Ricovero e Cura a Carattere Scientifico) di Reggio Emilia.
The analysis will be carried out on the right lower limb of each subject. The electromyographic devices will be applied to the tibialis anterior, peroneus longus, gluteus medius, gluteus maximus and adductor longus.
Reflective markers will then be applied (using double-sided tape) according to the Total3DGait protocol, which identifies the body segments of the forearms, arms, trunk, pelvis, thighs, legs, and feet.
The subject must position himself with his right foot on a force platform. The toe of the left foot will be allowed to rest on the ground (on the other power platform posteriorly placed), with the verbal indication to load as little weight as possible on it: this indication is aimed at reducing muscle activation in the absence of external perturbations, in order to highlight only the activity caused by the perturbations themselves. Only acquisitions in which the load on the left foot will be less than 30% of the weight will be considered valid.
The hands will be placed on the hips to limit the variables to be controlled and to standardize the posture, in order to focus the contribution to the balance of the lower limb. The left thigh has to be kept vertical. Finally, it will be required to find, within the constraints described above, the posture that is as comfortable as possible, with minimal muscle contraction. The distance between the feet is therefore freely chosen by each subject.
The operator positions himself behind the subject to be examined, and without being seen performs lateral thrusts with the medial margin of the hand at the proximal third of the thigh. At least ten pushes per side will be performed, with random timing. The thrusts will be quick but without causing pain.
The operator will then request maximal contractions from the subject, in order to normalize the electrical activity of each muscle with respect to its maximum. It will be required to perform the dorsiflexion and pronation of the foot against resistance, then the adduction, abduction and extension of the hip.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unbalanced healthy subjects | Experimental | Other: Medio-lateral imbalanceSubjects undergo an external perturbation of their balance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All healthy subjects
Key exclusion criteria (2 listed)
- skeletal pathologies compromising balance
- neuromotor pathologies compromising balance
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 |
|---|---|---|
| Medio-lateral imbalanceThrust on the pelvis in the medio-lateral direction in order to create a balance perturbation | Other | Unbalanced healthy subjects |
Primary outcome
Maximum electrical intensity during early response of muscle activation
Time frame: During the procedure
The muscles considered will be, for the anterior spiral chain, the adductor longus and the peroneus longus, for the posterior spiral chain, the glutei (medius and maximus) and the tibialis anterior. For each muscle, the intensity will be normalized to the intensity of the maximal contraction. Muscle activity will be evaluated for 1500ms, 500ms before and 1000ms after the thrust. The early response to the stimulus will be identified in the interval of 100-500ms after the thrust.The thrusts will be performed 10 times towards the medial direction and 10 towards the lateral. The median intensity for each direction will be calculated.
Correlation of muscle activity
Time frame: During the procedure
Correlation coefficients of the activation intensity between each muscle of the hip and each muscle of the ankle: tibialis anterior-glutei; tibialis anterior-adductor longus; peroneus longus-glutei; peroneus longus-adductor longus. Calculated for each imbalance direction.
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 17 Oct 2022.
- BackgroundColonna S., 2012. Le catene miofasciali in medicina manuale - Arto inferiore: Ginocchio, Ed. Martina.
- Background: PubMed 15836939Morey-Klapsing G, Arampatzis A, Bruggemann GP. Joint stabilising response to lateral and medial tilts. Clin Biomech (Bristol). 2005 Jun;20(5):517-25. doi: 10.1016/j.clinbiomech.2005.01.008.
- 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.
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 Medio-lateral imbalance in people with Healthy, run by Manusapiens at 1 site in Italy.
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 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 17 Oct 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 Italy. 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?
Maximum electrical intensity during early response of muscle activation (time frame: During the procedure). 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 NCT05080036, 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 17 Oct 2022.