Muscular Disorders, Atrophics-EMGNCT06217835
What Are the Effects of Lower Limb Dysmetria on Gluteus Medius and Erector Spinae Musculature?
A study testing To evaluate the response of an orthopedic insole and evaluate activation of musculature in people with Muscular Disorders, Atrophic, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Disorders, Atrophic
- What is being tested?
- To evaluate the response of an orthopedic insole and evaluate activation of musculature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2023to 8 Sep 2023
- 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
- -
Who cannot join
- The volunteers had no problems in range of motion of joints of the lower limbs
- pelvic obliquity due to a functional leg length discrepancy.
- obesity with body mass index (BMI) 35 > kg/m²
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Activity of Erector Spinae and Gluteus Medius Muscles With the Presence of Simulated Lower Limb Dysmetria
Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex.
The aim of present study was to investigate whether modifying lower limb length with a different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ.
Read the detailed description
Background: Length leg discrepancy (LLD), regardless of its origin, is a very common pathology that can contribute to low back pain. Various authors point out its relationship with the lack of activation of both the gluteus medius (GM) and the ipsilateral erector spinae (ES). The purpose of this study was to identify the activation of Es and GM with different simulated LLD, correlating said activation with the LBP. In turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ. (2) Method: a sample of healthy subjects was selected to whom an artificial LLD was incorporated through a 0.5, 1 and 1.5 cm insole, measuring with EMGs in these 3 moments while walking and performing a counter movement jump (CMJ). The measurement was carried out in random order, in terms of insole height, using a Latin Square. Muscle activation patterns were recorded for 30 seconds at each of the insole heights while walking at 5.7 km/h and compared with the maximum voluntary contraction (MVC), both on the ipsilateral and contra-lateral sides. These muscles were then measured under the same circumstances during the development of the CMJ. (3)
- Conditions
- Muscular Disorders, Atrophic
- Being tested
- To evaluate the response of an orthopedic insole, evaluate activation of musculature
- Keywords
- Low Back Pain, electromyography, Leg Length Inequality, lower limb length
- Medical subject headings
- Muscular Disorders, Atrophic, Low Back Pain, Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate the response of an orthopedic insoleOther
To evaluate the response of an orthopedic insole of different heights on gait.
evaluate activation of musculatureOther
To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.
| Study group | Role | What they receive |
|---|---|---|
| 0,5 cm jig | Experimental | A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute. Receives: Other: To evaluate the response of an orthopedic insole; Other: evaluate activation of musculature |
| 1 cm jig | Experimental | A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute. Receives: Other: To evaluate the response of an orthopedic insole; Other: evaluate activation of musculature |
| 1,5 cm jig | Experimental | A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute. Receives: Other: To evaluate the response of an orthopedic insole; Other: evaluate activation of musculature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height CMJ
CMJ jump flight height
Measured: 1 week
Height DJ LEFT
Flying height in drop jump left leg
Measured: 1 week
Height DJ RIGHT
Flying height in drop jump right leg
Measured: 1 week
Gluteus medius (mv)
Gluteus medius activation (mv)
Measured: 1 week
Erector Spinae (mv)
Erector Spinae activation (mv)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start20 Mar 2023
- Primary completion3 Jun 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Disorders, AtrophicStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Cimadevilla, PT, Study director, Camilo Jose Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217835
- Sponsor's protocol ID
- CamiloJcU-Fisio
- Acronym
- s-EMG
- Status last verified
- Apr 2024
- First submitted
- 4 Dec 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Activity of Erector Spinae and Gluteus Medius Muscles With the Presence of Simulated Lower Limb Dysmetria
- ClinicalTrials.gov ID
- NCT06217835
- Acronym / sponsor ID
- s-EMG / CamiloJcU-Fisio
- Conditions
- Muscular Disorders, Atrophic
- Keywords
- Low Back Pain, electromyography, Leg Length Inequality, lower limb length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 23 Jan 2024 (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.
Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex.
The aim of present study was to investigate whether modifying lower limb length with a different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ.
Detailed description
Background: Length leg discrepancy (LLD), regardless of its origin, is a very common pathology that can contribute to low back pain. Various authors point out its relationship with the lack of activation of both the gluteus medius (GM) and the ipsilateral erector spinae (ES). The purpose of this study was to identify the activation of Es and GM with different simulated LLD, correlating said activation with the LBP. In turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ. (2) Method: a sample of healthy subjects was selected to whom an artificial LLD was incorporated through a 0.5, 1 and 1.5 cm insole, measuring with EMGs in these 3 moments while walking and performing a counter movement jump (CMJ). The measurement was carried out in random order, in terms of insole height, using a Latin Square. Muscle activation patterns were recorded for 30 seconds at each of the insole heights while walking at 5.7 km/h and compared with the maximum voluntary contraction (MVC), both on the ipsilateral and contra-lateral sides. These muscles were then measured under the same circumstances during the development of the CMJ. (3)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0,5 cm jig | Experimental | Other: To evaluate the response of an orthopedic insole, Other: evaluate activation of musculatureA template with the dimensions indicated is introduced to the user and he/she walks for 1 minute. |
| 1 cm jig | Experimental | Other: To evaluate the response of an orthopedic insole, Other: evaluate activation of musculatureA template with the dimensions indicated is introduced to the user and he/she walks for 1 minute. |
| 1,5 cm jig | Experimental | Other: To evaluate the response of an orthopedic insole, Other: evaluate activation of musculatureA template with the dimensions indicated is introduced to the user and he/she walks for 1 minute. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- The volunteers had no problems in range of motion of joints of the lower limbs
- pelvic obliquity due to a functional leg length discrepancy.
- obesity with body mass index (BMI) 35 > kg/m²
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 |
|---|---|---|
| To evaluate the response of an orthopedic insoleTo evaluate the response of an orthopedic insole of different heights on gait. | Other | 0,5 cm jig, 1 cm jig, 1,5 cm jig |
| evaluate activation of musculatureTo evaluate the response caused by an orthopedic insole of different heights on the indicated musculature. | Other | 0,5 cm jig, 1 cm jig, 1,5 cm jig |
Primary outcome
Height CMJ
Time frame: 1 week
CMJ jump flight height
Height DJ LEFT
Time frame: 1 week
Flying height in drop jump left leg
Height DJ RIGHT
Time frame: 1 week
Flying height in drop jump right leg
Gluteus medius (mv)
Time frame: 1 week
Gluteus medius activation (mv)
Erector Spinae (mv)
Time frame: 1 week
Erector Spinae activation (mv)
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 30 Apr 2024.
- 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.
Eduardo Cimadevilla, PT study director
Camilo Jose Cela University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To evaluate the response of an orthopedic insole and evaluate activation of musculature in people with Muscular Disorders, Atrophic, run by Camilo Jose Cela University 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 3 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 30 Apr 2024. 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?
Height CMJ (time frame: 1 week). The study lists 5 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 30 Apr 2024.