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OpenTrials
Completed

NCT Number: NCT03434756

Stabilizer in Abdominal Wall Muscles

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults

Exclusion criteria

  • Body mass index higher than 31 kg/m2,
  • Hypocapnia,
  • Any musculoskeletal condition in lumbopelvic region,
  • Skin and lower limb pathology (i.e., fracture, surgery)

Treatment and study plan

Propioceptive training of the abdominal wall muscles

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Propioceptive StabilizerTM Training in the Abdominal Wall Muscles in Healthy Subjects: A Pilot Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2018
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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