HealthyNCT03434756
Stabilizer in Abdominal Wall Muscles
A study testing Propioceptive training of the abdominal wall muscles in people with Healthy, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The aim of the study will be tried to observe if the propioceptive Stabilizer training is effective in abdominal wall muscles in healthy subjects. All the participants will be examined in two times. Initially, baseline measurements with ultrasound imaging will be taken without muscle activity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propioceptive training of the abdominal wall muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2018to 25 Feb 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
Who cannot join
- Body mass index higher than 31 kg/m2,
- Hypocapnia,
- Any musculoskeletal condition in lumbopelvic region,
- Skin and lower limb pathology (i.e., fracture, surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propioceptive StabilizerTM Training in the Abdominal Wall Muscles in Healthy Subjects: A Pilot Study
The aim of the study will be tried to observe if the propioceptive Stabilizer training is effective in abdominal wall muscles in healthy subjects. All the participants will be examined in two times. Initially, baseline measurements with ultrasound imaging will be taken without muscle activity. After, they will do the abdominal manoeuvre and it will take the ultrasound images.
Read the detailed description
Inclusion criteria will be health participants with age between 18 to 45 years. Exclusion criteria were a BMI higher than 31 kg/m2, hypocapnia, any musculoskeletal condition in lumbopelvic region, skin and lower limb pathology (i.e., fracture, surgery).
Initially, baseline measurements will make following Whittaker et al. guidelines to measure thickness of the abdominal wall muscles (external oblique, EO; internal oblique, IO; transversus abdominis, TrA and rectus anterior, RA). All evaluations will be carry out by a single operator (B.M.P), who was a specialized physical therapist with 3 years of USI experience. A diagnostic ultrasound tool (Toshiba Aplio 500 Platinum, Toshiba American Medical Systems; CA, USA) with a 7 to 14-MHz-range linear transducer (18L7 PLT-1204BT type; 40-mm footprint) will be used for B mode ultrasound imaging. Ultrasound images of the EO, IO and TrAb muscles will be taken with the patients in supine position, with a cross reference point placed between the iliac crest and the inferior border of subcostal line, and the midaxilary line on the right side ; RA muscle was aligned with the umbilicus; and interrecti distance (IRD) will be measured just under the umbilicus. The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. IRD will be described as the distance between the inside caliper lines of each RA muscles.
Once baseline measurements will be taken, the same measurements will make while the patients perform the exercise. This exercise specifically targets the abdominal wall muscles (EO, IO, TrA and RA). At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal draw in maneuver (ADIM) was developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject will be practiced the ADIM three times with an ultrasound image feedback.
- Conditions
- Healthy
- Being tested
- Propioceptive training of the abdominal wall muscles
- Keywords
- ultrasound imaging, propioception, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propioceptive training of the abdominal wall musclesOther
At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal manoeuvre will be developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject practiced the abdominal manoeuvre three times with an ultrasound image feedback.
| Study group | Role | What they receive |
|---|---|---|
| Propioceptive Training | Experimental | Not described Receives: Other: Propioceptive training of the abdominal wall muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness abdominal wall muscles
The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. IRD will be only evaluated in the midline. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. Interrecti distance will be described as the distance between the inside caliper lines of each Rectus Anterioris muscles.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start18 Feb 2018
- Primary completion22 Feb 2018
- Study completion25 Feb 2018
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Romero Morales, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434756
- Sponsor's protocol ID
- CIPI/087/17
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
PubMed 17877281Miura T, Yamanaka M, Ukishiro K, Tohyama H, Saito H, Samukawa M, Kobayashi T, Ino T, Takeda N. Individuals with chronic low back pain do not modulate the level of transversus abdominis muscle contraction across different postures. Man Ther. 2014 Dec;19(6):534-40. doi: 10.1016/j.math.2014.05.010. Epub 2014 Jun 20.
PubMed 25009124
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propioceptive StabilizerTM Training in the Abdominal Wall Muscles in Healthy Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT03434756
- Acronym / sponsor ID
- CIPI/087/17
- Conditions
- Healthy
- Keywords
- ultrasound imaging, propioception, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 15 Feb 2018 (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 aim of the study will be tried to observe if the propioceptive Stabilizer training is effective in abdominal wall muscles in healthy subjects. All the participants will be examined in two times. Initially, baseline measurements with ultrasound imaging will be taken without muscle activity. After, they will do the abdominal manoeuvre and it will take the ultrasound images.
Detailed description
Inclusion criteria will be health participants with age between 18 to 45 years. Exclusion criteria were a BMI higher than 31 kg/m2, hypocapnia, any musculoskeletal condition in lumbopelvic region, skin and lower limb pathology (i.e., fracture, surgery).
Initially, baseline measurements will make following Whittaker et al. guidelines to measure thickness of the abdominal wall muscles (external oblique, EO; internal oblique, IO; transversus abdominis, TrA and rectus anterior, RA). All evaluations will be carry out by a single operator (B.M.P), who was a specialized physical therapist with 3 years of USI experience. A diagnostic ultrasound tool (Toshiba Aplio 500 Platinum, Toshiba American Medical Systems; CA, USA) with a 7 to 14-MHz-range linear transducer (18L7 PLT-1204BT type; 40-mm footprint) will be used for B mode ultrasound imaging. Ultrasound images of the EO, IO and TrAb muscles will be taken with the patients in supine position, with a cross reference point placed between the iliac crest and the inferior border of subcostal line, and the midaxilary line on the right side ; RA muscle was aligned with the umbilicus; and interrecti distance (IRD) will be measured just under the umbilicus. The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. IRD will be described as the distance between the inside caliper lines of each RA muscles.
Once baseline measurements will be taken, the same measurements will make while the patients perform the exercise. This exercise specifically targets the abdominal wall muscles (EO, IO, TrA and RA). At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal draw in maneuver (ADIM) was developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject will be practiced the ADIM three times with an ultrasound image feedback.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propioceptive Training | Experimental | Other: Propioceptive training of the abdominal wall muscles |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (4 listed)
- Body mass index higher than 31 kg/m2,
- Hypocapnia,
- Any musculoskeletal condition in lumbopelvic region,
- Skin and lower limb pathology (i.e., fracture, surgery)
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 |
|---|---|---|
| Propioceptive training of the abdominal wall musclesAt the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal manoeuvre will be developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject practiced the abdominal manoeuvre three times with an ultrasound image feedback. | Other | Propioceptive Training |
Primary outcome
Thickness abdominal wall muscles
Time frame: 1 day
The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. IRD will be only evaluated in the midline. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. Interrecti distance will be described as the distance between the inside caliper lines of each Rectus Anterioris muscles.
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 18 Apr 2018.
- Background: PubMed 17877281Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
- Background: PubMed 25009124Miura T, Yamanaka M, Ukishiro K, Tohyama H, Saito H, Samukawa M, Kobayashi T, Ino T, Takeda N. Individuals with chronic low back pain do not modulate the level of transversus abdominis muscle contraction across different postures. Man Ther. 2014 Dec;19(6):534-40. doi: 10.1016/j.math.2014.05.010. Epub 2014 Jun 20.
- Individual participant dataSharing planned: Undecided
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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 Propioceptive training of the abdominal wall muscles in people with Healthy, run by Universidad Europea de Madrid 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 4 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 18 Apr 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?
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?
Thickness abdominal wall muscles (time frame: 1 day). 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 NCT03434756, 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 18 Apr 2018.